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World Trust Pharmacy

  • Generic HIV drugs - Essential advice

    Viraday - generic version of HIV drug AtriplaGiven the increase in customers  ordering generic HIV drugs from our site, our pharmacy team have created this article to help consumers further understand:

    - their effectiveness

    - differences between brand and generics

    - why there are so few generic versions of HIV drugs available in the USA

    Effectiveness

    The first point to be clear on is that generic drugs are bio-equivalent copies of brand-name drugs. They have the same formulation, strength, quality, performance, dose, and method of administration.

    For generic HIV drugs to be accepted by the FDA as alternatives to their brand name counterparts, they have to satisfy those specifications.

    As a result, the generic drugs will have similar rates of absorption into the body. By satisfying these requirements, the generic HIV drug and the brand name drug will provide the same therapy.

    The widespread misconception, that generic drugs contain a lower concentration of the active ingredients in brand-name drugs, is based on a fallacy. They produce the same antiretroviral effects as their brand name counterparts.

    Clinical trials have shown that their use is safe and poses no harm to the human body. Even the side effects are similar due to their resembling chemical composition.

    Some of these generic HIV drugs are manufactured by brand name companies or in partnership with them.

    What is the difference between brand and generic HIV medication?

    Generic drugs (including those used against HIV) are only differentiated from their brand name counterparts by the inactive ingredients and physical properties. They may differ in the dyes used to color the drug, the shape of the drug and the size of the pill.

    Cost savings

    The biggest difference comes in their pricing. Generic versions of HIV drugs are significantly cheaper than brand name drugs. Sometimes the drugs might cost up to 2000 times less than the brand products.

    For instance, we sell generic Truvada (Tenvir-em) for just $1.99 when brand Truvada is at least $50 a tablet from top USA pharmacies.

    The majority of physicians in the UK have embraced the prescription of generic drugs to their patients. They are gradually gaining acceptance as low-cost treatment options. By using generic HIV medication you benefit from the same treatment results at a fraction of the cost.

    In the USA, around 88% of all prescription drugs dispensed are for generic drugs, however in terms of HIV drugs the number is much lower due to the lack of HIV generics available in the USA.

    A study was conducted by a team from Weill Cornell Medical under the guidance of Professor Bruce Schackman. Using accredited models they established that switching to generic versions of HIV drugs would result in the country saving close to 1 billion dollars during the first year.

    As it stands, a person living with HIV is expected to spend around 2600 dollars every month to buy a 30-day supply of pills. The price differs depending on the combination of the drugs.

    The centers for disease control estimates that you can rack up a staggering cost of up to $250,000 USD, depending on when you began antiretroviral therapy.

    Despite such revelations, the U.S has seen a low uptake of generic HIV drugs due to several impediments. The biggest among them is the drive for profit since all pharmaceutical companies are looking for money. Other factors politically motivated or touching on the science involved.

    Reasons why there are so few generic HIV drugs available in the U.S

    1. General skepticism

    Many patients, doctors, and pharmacists still think that HIV generic drugs perform poorly compared to brand name drugs. This is typical human behavior and stands as a barrier between generic HIV drugs and the market take-up of these products.

    Studies have shown that a majority of people hold this opinion. Also, pharmacists are more likely to view generic products as weaker than doctors. This makes prescription and reception a difficult achievement.

    2. Intellectual property rights

    Research and development is the most vital stage in the creation of drug process. Leading U.S drug companies spend a lot of money trying to come up with new HIV drugs ($1 billion is not uncommon) or make minor adjustments that will improve the drugs’ performance.

    A lot of this research is undertaken in the U.S through funding provided by the drug supply giants. By keeping the research in the country, they are in a position to protect their intellectual property rights from competing countries.

    In doing so, they get to be the sole beneficiaries of novel drugs for long periods of time before the drugs can be reproduced. The high cost of the patented drugs is sometimes attributed to the cost of research and development.

    Countries like India do not share the view on intellectual property law. Manufacturers are allowed to produce drugs which are patented in the U.S making it a leader in supplying generic drugs to developing countries.

    Since the formulas are protected, they end up making drugs which are chemically different. Although they might receive FDA or tentative approval, they are not fully trusted in the eyes of the public.

    3. Rapid technological advancements

    Patents on brand-name drugs normally expire after 20 years. After which, interested parties can be able to reproduce the drug for the mass market. Unfortunately, by the time the patent expires, the patent owners have made advancements and created a better product for the market.

    For example, Tenofovir alafenamide was released as an improvement of TDF in 2016. This happened right before the patent was set to lapse.

    When the generic version finally gets the FDA approval, the market will have moved on to a more current drug. At this point, trying to establish the generic brand in the U.S market is a daunting task. Science evolves so quickly rendering some medications obsolete.

    In the U.S market, currently, only a few generic drugs are used like Abacavir and Lamivudine.

    4. Poor government and healthcare provider motivation

    The HIV drug makers in the U.S enjoy a protected status in the market, internally and globally. Although there is completion in that space from generic drug manufacturers, they do not feel that pressure.

    This is primarily due to the popularity of one pill drug combinations. They are preferred by patients and doctors at treatment initiation. It a common perception, among practitioners, that one-pill combination is easier to take and may improve adherence. This is not a scientific fact but one-pill manufacturers are at an advantage since most patents for those drugs are far from expiry.

    Moving on from customer preferences is a government that leans more towards brand name HIV drugs. The biggest buyer of ARV drugs is the federal government. The U.S government is reluctant to put policies in place to facilitate generic drug entry into the market. Drug manufacturers sell directly to the government.

    The federal 340B drug pricing program ensures the customers get discounts. Pharmacies are reimbursed fully for selling brand-name drugs to customers.

    5. Department of Health

    Another blow to the generics industry is from the department of health. The AIDS drug assistance program operates based on guiding policies from the health department. Currently, one pill drug combinations are the guideline’s recommended option for HIV therapy initiation.

    A move inspired by studies that seem to indicate a better adherence ratio for one pill combinations than taking several pills. Though unintended, such moves discourage the penetration of HIV generics.

    6. Incentives from private drug companies

    The big drug companies recognize that financial constraints can be an impediment to their ability to sell. The HIV drug market also includes people who are underinsured or cannot afford insurance. For such individuals, the drugs are seemingly out of reach. In response, drug companies offer payment assistance or care subsidization for customers who are not covered.

    The generic HIV drug producers have no financial muscle to match them. Consequently, the brand name companies position themselves better to control the low income and high-income earners’ brackets. There is little to no protest against this open exploitation. Americans do not get to feel the pinch because of private and government subsidies among other plans.

    7. Low demand

    The demand for the generic drug is usually low because of newer drugs. The manufacturers of brand-name drugs usually have replacements or improvements ready by the time patents expire. These become the preferred drugs while the ones with expired patents are given lower priority. As a result, most generic manufacturers will be discouraged from going into their production.

    Luckily, due to the affordability of generic versions, they might still be recommended by insurance companies. This motivates production and as more players get into the industry then the cost can only go lower. For instance, the generic combination of abacavir and lamivudine is used as a first-line regimen. Parties have come in to produce more it for those who need it. So there is a ray of hope.

    Under such circumstances, it is easy to see why generic HIV medications are not readily available in the U.S market despite their benefits. Surprisingly, many big drug American drug companies have benefited or participated in the generic HIV drugs business.

    8. Brand drugs contain ingredients from China and India

    It is a known fact that the sources of ingredients for American drug companies are Chinese and Indian. Some go as far as importing the finished products from the same countries. In some cases, brand name companies partner with overseas drug makers to produce generic drugs.

    The irony is that these drugs are not availed to the American market even though they are made by their companies.

    A good example is the purchase of matrix laboratories in India by Mylan; a company based in Pennsylvania. Matrix is a leader in producing the active ingredients for generic drugs. As a result of the purchase, Mylan became one of the most instrumental players in the generic drugs industry. It is not an isolated case.

    The generic drug industry stakes owned by big American drug companies are quite significant. India companies take home a mere 2% of the annual global revenue.

    Popular generic versions of HIV brands include abacavir, lamivudine, Viraday, Instgra and Tenvir EM.

    An overview of the most popular generic HIV drugs

    Tenvir EM

    Tenvir EM is manufactured by Cipla and is a combination of Emtricitabine and Tenofovir. It is the most widely used of all generic versions of Truvada for HIV-1 in adults. A month’s supply of 30 tablets will only cost $59 USD, which is affordable compared to the Truvada equivalent cost of $1500.

    Because of the FDA’s tentative approval, it is not available in local pharmacies but can be purchased online.

    For optimum performance, it has to be taken with another drug. Clinical trials have shown a 75% efficiency rate in prevention of new infection. This is tied to proper adherence. The efficacy was affected by different behaviors among populations that are at risk of getting the virus. The study indicated that drug resistance was not observed and that to prevent it from occurring, a test should be done to ensure no traces of the virus can be found.

    There are a number of side effects experienced by users. They are similar to those shown by Truvada users such as nausea, diarrhea, dizziness, and fatigue and skin rash. Some have reported losing sleep and getting nightmares. It is not by breastfeeding or pregnant mothers, people with liver conditions and allergies.

    Viraday

    Also a product from Cipla, it is the generic version of Atripla. It combines Efavirenz, Emtricitabine, and Tenofovir.

    A month’s supply will cost you about $104 USD which is significantly lower than the $2800 USD charged for the same dose of Atripla tablets from most USA pharmacies. You are required to take one pill a day. If you forget, you can take one within 12 hours.

    It has the same side effects as Atripla with users mentioning nausea, abdominal pain, loss of appetite and diarrhea among others some allergic reactions may be difficulty breathing.

    Instgra

    The generic version of Tivicay contains dolutegravir as the active ingredient. It is manufactured by Emcure pharmaceuticals.

    For about $149 USD, you can get a 30 day supply.

    It should be taken once a day. If you happen to miss a dose, do it as soon as you remember but do not take two at once.

    Instgra should be administered with other HIV drugs for better results and works by It inhibing the integration of HIV in the body.

    Some of the side effects are fatigue, feeling dizzy, headaches and mild depression. It is not recommended for people with allergic reactions to its ingredients, pregnant and breastfeeding mothers or using iron and calcium supplements.

    Conclusion

    Generic HIV medication is now gaining acceptance as the drugs of choice for HIV therapy. The goal to have provided affordable ART therapy to citizens of the world is now more conceivable than ever.

    What is now needed is unity among governments to make generic drugs available to those who need them.

    As a result, the global cost of treatment will be reduced and resources can be redirected to supporting other health-related areas.

    Author: Mea - Senior Pharmacist at World Health Pharmacy

  • Why millions of people are alive thanks to affordable Indian generics

    India is now the world's largest provider of generic drugs to worldwide markets

    indian generic drugs sales growth graph

    India is now 4th biggest generic drug producer in the world and has 20% of the global generic drug market

    BRIC countries such as Brazil, Russia, India, China together with Mexico and Turkey are continuing to show strong growth in the generic drugs market. For example, Indian generics manufactured in India are already help millions of people reduce their healthcare costs by providing generic drugs at a significant discount to US brand counterparts.

    Indian drug manufacturers currently export their products to more than 65 countries worldwide.Their largest customer is the U.S., the world's biggest pharmaceutical market.

    Within the next 5 years emerging markets such as Brazil, Russia, India, China, Mexico and Turkey (BRIC-MT countries) are anticipated to account for $190 billion in sales growth, with approximately 40% from innovative drugs.

    Why are Indian generics so popular?

    “Thanks to the dexterity of the pharmaceutical industry, the presence of a huge number of trained chemists and a large domestic market, drugs are incredibly cheap in India, and India is one of the greatest producers of generic drugs,” said Sumit Ganguly, professor of political science at Indiana University.

    India is a shining light in the global pharmaceuticals industry with its unique blend of low-cost manufacturing, R&D infrastructure and skilled workforce. Foreign companies are also attracted to India’s production costs, which are significantly lower than in the U.S. and almost half that of Europe.

    India’s ability to manufacture low-cost generics also stems from economic factors favoring the industry, including competitive land rates, cheap labor, low-cost utilities and affordable equipment.

    Improvements to Indian generics drug safety

    As overseas companies manufacture drugs in India and market them around the world, they must still ensure their products meet the strict quality contorl standards set by their target country markets.

    On this note, India’s Pharmacopoeia Commission of the Ministry of Health and Family Welfare continues to increase medicine quality standards to help promote the growth of the pharma sector and improve public health.

    The Indian pharma industry has made significant investments in improving its manufacturing plants to meet international standards such as U.S. Food and Drug Administration (USFDA), according to a 2015 report from Deloitte.

    The FDA maintains 2 Indian inspection offices and has approved around 600 manufacturing facilities so far.

    Massive number of Indian FDA inspected manufacturing plants

    Amazing facts :

    1. India now has the most number of FDA inspected manufacturing plants outside the USA.
    2. The cost of establishing an FDA-inspected plant in India is approximately 50% percent less than it would be in developed countries.
    3. Operation and production costs run 40%-70%lower than in developed nations (factors include local equipment sourcing, tax incentives and a focus on process innovation) and labor costs are on average 60% to 70% less than developed countries such as America.

    To understand more about Generic Drugs, please visit our Generic Drug Information Center that will help answer many of your questions or concerns.

    Checkout our most popular tweet on this subject (3500 impressions)


  • Are prescription drugs from India safe? Brand and generic drugs

    Are prescription drugs from India safe?

    Key facts about prescription drugs made in India

    1. Over 9 million Americans buy their prescription drugs overseas every year!
    2. India’s pharmaceutical industry supplies 40% of over-the-counter and generic prescription drugs consumed in the United States, so the increased scrutiny could have profound implications for American consumers
    3. India is now the worlds largest provider of generic medications with a 20% market share (and growing)
    4. 88% of all prescription drugs prescribed in America are for generics

    Are prescription drugs from India safe?

    The vast majority of prescription drugs are now made outside the U.S, with India being the 2nd biggest exporter with 20% market share. Most of the active ingredients for prescription drugs are also imported from India and other overseas nations.

    Some drugs approved in America are either fully manufactured overseas, or have some of the ingredients imported from overseas.

    Given that there are now over 520 India pharmaceutical manufacturers making products for the American market, it is unfortunate that a small handful of these (whose drugs we do not sell) have fallen foul of various FDA inspections for specific drugs. However, the FDA also reports pharma companies from the USA and other countries so the issue is not just linked to India.

    Many officials would like to see a regulatory system in India that looks more like the European Union, where the central European Medicines Agency oversees the 28 member state regulatory framework.

    Last year a report from New Delhi found that medicines made in India were found to be safe and effective, after a year-long health ministry survey tested around 50,000 drug samples across India.

    The Central Drug Standard Control Organisation (CDSCO) stated that

    "What has come out in the survey is that the extent of not-of-standard-quality drugs in India is lesser than the not-of-standard-quality drugs elsewhere in the world. The largely held perception circulating and magnified many times over that India is one of the (biggest) producers of substandard quality of drugs has proven to be wrong,"

    In an ideal world this investigation would be done by an independent foreign body to ensure complete impartiality of the testing and results - but who would that be?


    What is being done by the FDA to improve the safety of prescription drugs from abroad?

    All drugs approved in the U.S.A, regardless of which country they were made, must be in compliance with the Federal Food, Drug, and Cosmetic Act. This ensures that drugs meet strict manufacturing standards to assure quality and product label requirements.

    The FDA also help ensure drug safety as listed below:

    1. The FDA is working on a major research programme with academic institutions, whose main purpose is to improve the availability and safety of U.S. generic drugs
    2. Their Globalization Initiative Programme helps ensures imported drugs are as effective and safe as those products made in America.
    3. The FDA continues to deploy more inspectors in those developing countries supplying more of the worlds medicine (such as India), to ensure they are following Current Good Manufacturing Practices (GMP).
    4. The agency is also working closer with all the relevant regulatory counterparts in these countries.
    5. The FDA routinely sample and tests drugs from manufacturing sites, retail outlets and wholesale distributors, the results of which help drive further drug safety regulations, education and surveillance.
    6. The FDA also monitors and evaluates complaints from doctor,nurses and consumers and drug defect reports to ensure drug recalls and improved safety.

    So are prescription drugs from India safe?

    Well yes, otherwise:

    1. Millions of people around the world (including America) wouldn't be buying medicines manufactured in India
    2. USA pharma manufacturers would not be importing their drugs active ingredients from India.
    3. We wouldn't be selling them! Two of our best selling drugs are from India - Viraday Cipla Tablets and Tenvir-EM Cipla tablets
    4. Since our launch, we have not had one customer refund request and that includes USA customers buying specialty and HIV drugs such as Glivec, Eliquis, Truvada, Viraday, Tenvir-EM, Isentress and thousands more.

    Why are prescription drugs from India so much cheaper than prescription drugs made in USA?

    We frequently have chats and emails with our customers who understandably ask why our prices are so low compared to what they are currently paying.

    They think surely the medication from India cannot be genuine or as effective as their USA counterpart.

    The answer is simple. 

    Our products are all 100% genuine and the reason they are so cheap is because they are manufactured and sold by the Indian pharmaceutical companies for the local Indian market. We therefore pass these savings on to our worldwide customers including the United States.

    Many of the brand medications have the same manufacturer in the USA and India (e.g. Novartis Gleevec/Glivec) and we just source from their Indian divisions to keep our prices low.

    Also please remember the same prescription drug from the USA and India has the same active ingredients and are therapeutically equivalent (the same applies to a brand or generic version).

    However, we also understand peoples concerns about not trusting the cheap brand and generic versions produced in India, even if they are the same as their counterparts manufactured in the USA.

    Always remember to make sure the online drugs you buy are from a legitimate pharmacy that always requests a valid prescription for your prescription drugs and does not sell fake or controlled drugs!

  • 2017 Formulary drug removals for Express Scripts and CVS

    The list of drugs below have been removed from CVS and Express scripts formulary for 2017. This list is effective January 1, 2017.

    If you continue using one of the drugs listed below that is identified as a Formulary Drug Removal, you may be required to pay the full cost.

    If you are currently using one of the formulary drug removals, ask your doctor to choose one of the generic or brand formulary options.

    We have provided links to our cheaper brand and generic versions of the drugs below, so that even if you have to pay full price, it will be upto 90% less than the typical USA pharmacy price.

    EXPRESS SCRIPTS 2017 EXCLUDED DRUG LIST

    Abbott (FreeStyle, Precision)
    Abstral
    Acuvail
    ADV MED TECH (TRUEtest, TRUEtrack)
    Advocate
    Alogliptin
    Alogliptin/Metformin
    Alvesco
    Apidra
    Aranesp
    Asacol HD
    Bayer (Breeze, Contour)
    Beconase AQ
    Bravelle
    Cetraxal
    Cimzia
    Colchicine
    Daklinza
    Delzicol
    Dipentum
    Doxycycline 40 MG Capsules
    Duexis
    Endometrin
    Epogen
    Estrogel
    Evzio
    Fentora
    Fluorouracil 0.5% Cream
    Follistim AQ
    Fortesta
    Ganirelix Acetate Gel-One
    Genvisc 850
    Glumetza
    Hyalgan
    Hymovis
    Istalol
    Kazano
    Kineret (Exclude for RA)
    Kombiglyze XR
    Levitra
    Mircera
    Natesto
    Nesina
    Novolin
    NovoLog
    Nutropin AQ
    Olysio
    Omnaris
    Omnis Health (Embrace, Victory)
    Omnitrope
    Onglyza
    Orencia
    Pancreaze
    Pertzye
    Proventil HFA
    Qsymia
    ribasphere
    ribapak
    RibaTab
    Roche (Accu-Chek)
    Saizen
    Simponi 50 MG
    Sovaldi
    Staxyn
    Stendra
    Subsys
    Supartz
    Supartz FX
    Synvisc
    Synvisc-One
    Taltz
    Tanzeum
    Testim
    Testosterone Gel
    Ultresa
    UniStrip
    Veltin
    Veramyst
    Victoza
    Vimovo
    Vogelxo
    Xopenex HFA
    Zepatier
    Zetonna
    Zioptan
    Zomacton
    Zyclara

    CVS 2017 EXCLUDED DRUG LIST

    Abstral;
    Alcortin A gel,
    All non-Becton Dickinson pen needles and syringes;
    Aloquin gel,
    Amitiza;
    Butalbital/APAP/Caffeine Capsules (All Brands and Generics, not tablets);
    Carnitor/ Carnitor SF oral solution (MSB);
    Crestor (MSB);
    Daklinza,
    DexPak oral tablets,
    Duexis,
    Dutoprol oral tablets;
    Dymista,
    Enablex (MSB),
    Evzio;
    Gelnique,
    Gleevec (MSB),
    Helixate FS,
    Klor-Con oral pack for solution;
    Lantus,
    Millipred/ Millipred DP oral tablets, dose pack and oral solution;
    Neupogen,
    Nexium (MSB),
    Nilandron oral tablets;
    Novacort gel;
    Olysio,
    Opsumit;
    Pradaxa;
    Proventil,
    SNRI’s Venlafaxine ER Tablets, except 225mg (All Brands and Generics);
    Tasigna;
    Technivie,
    Tobi Podhaler/ Tobi (MSB),
    Toujeo;
    Toviaz;
    Ventolin
    Vimovo;
    Xenazine (MSB);
    Xtandi,
    Zegerid oral suspension and capsules (MSB);
    Zepatier;

    For a full list of exclusions and further information please see here

    http://www.caremark.com/portal/asset/Formulary_Exclusion_Drug_List.pdf

    You can quickly check the price of any of your medications by entering the brand or generic name into the search bar at the top of our pages

  • Drugs going off patent through 2020

    Looking to find out more information about drugs going off patent through 2020?

    This post provides information on the "patent cliff" and links to what we consider the three best articles on the internet regarding patent cliffs and upcoming patent expirations.

    What is the Patent Cliff?

    The 1984 Hatch-Waxman Act of 1984 kick-started the generic drug industry and helped launch the notorious “patent cliff” era of 2010–2015, when patents for many blockbuster drugs expired. The main “patent cliff” era maybe over, but upcoming patent expirations still provide a massive potential market for new generic drugs.

    The patent cliff is a period when patents for many of the small molecule blockbuster drugs, such as Nexium (esomeprazole) and Lipitor (atorvastatin), expired. For example, between 2009 and 2014 over $120 billion in branded pharmaceutical sales were lost due to patent expirations.

    This then allows generic drug companies to make cheaper versions of the brand drugs, whilst still benefiting from the profits. The first generic company to gain approval benefits from an exclusive 180 day marketing period. After 180 days, other generics from other companies can also be released. This in turn should benefit consumers due to generic drug price drops due to this increased competition.

    However, given the recent increase in large molecule biologics, is the patent cliff really over?

    Main drugs going off patent through 2017

    This excellent infographic from Dicksondata shows the major drugs off patent through 2017

    Major drugs going off patent 2017 Major drugs off patent through 2017

     

    Upcoming Biologics Expiry Dates

    A brand biologic patent has to expire first before an approval on a generic bio-similar can be released. However, many biologics have a long waiting period before bio-similar competition can affect pricing.

    The Generics and Biosimilars Initiative has listed the following key upcoming biologic patent expirations:

    • Erbitux (cetuximab) - Feb 2016
    • Rituxan (rituximab) - Sept 2016
    • Herceptin (trastuzumab) - June 2019
    • Avastin (bevacizumab) - July 2019
    • Aranesp (darbepoetin alfa) - May 2024
    • Enbrel (etanercept) - Nov 2028

     

    Drugs going off patent through 2020 - Recommended links

    https://www.drugs.com/slideshow/looking-ahead-pharma-projections-for-2016-and-beyond-1230

    http://marketrealist.com/2016/03/drug-patent-expirations-190-billion-sales-grabs/

    https://newdrugapprovals.org/patent-expiry/

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