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Generic drug industry

  • 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

  • Are prescription drugs from India safe? Brand and generics

    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

    Easily share these amazing facts ! Click here to tweet them

    Drugs from India - are they really safe?

    You've probably come to this page as you've heard that you can save a massive amount on your healthcare costs by buying prescription drugs from overseas pharmacies, such as from India.

    Whilst this is certainly true, let us explain some essential points you need to be aware of.

    First of all,

    We are very proud of this fact:

    Since our launch, we have not had one customer refund request. Zero!

    This includes USA customers buying Indian sourced drugs (brand and generics), such as anti-cancer, HIV drugs and ED drugs.

    Examples include Glivec (Gleevec), Eliquis, Truvada (Tenvir-EM), Atripla (Viraday), and hundreds more.

    More importantly,

    1. The vast majority of prescription drugs are now made outside the U.S, with India being the 2nd biggest exporter with 20% market share.
    2.  Most of the active ingredients for prescription drugs are also imported from India and other overseas nations.
    3. Some drugs approved in America are either fully manufactured overseas, or have some of the ingredients imported from overseas.

    Whats the real story?

    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 from 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 really safe?

    In general 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! Most of our best selling drugs are from India - e.g. Viraday Cipla Tablets and Tenvir-EM Cipla tablets

    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. 

    Firstly, our products are all 100% genuine.

    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.

    Is the cheaper India version as effective as the USA version?

    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.

    This ensures they 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!

    Even if you decide not to purchase from our site, good luck with your search for cheaper medication, but be careful!

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  • The rising cost of prescription drugs compared

    The rising cost of prescription drugs is shown in this excellent interactive infographic, highlighting how the top 100 prescription drugs have increased in price since 2012.

    For example, Tetracycline has increased by 12,100% since 2016 !

    Simply highlight a circle to see prices of each drug or type in the name of the drug in the search bar.

  • Future generic drugs - India and China growth

    Future generic drugs - Emerging markets threaten the dominance of the USA Generics market 

    A new 2016 report The Future of Generic Drugs and Strategies for Commercial Success explains how emerging economies including India, China, Brazil, Russia, Mexico, Indonesia, Nigeria and Turkey pose a threat to the dominance of the US in the global generics market.

    The survey report predicts that the US will gradually lose its position as the biggest generic drugs market by global revenue with emerging economies such as India, China and Brazil taking a much larger share of the market.

    The survey of 47 industry experts in the future generic drugs report concluded :

    1. 29% believed China would become the biggest generics emerging market by revenue in the next 5 years
    2. 23% felt that India would lead in 5 years.

    Future generic drugs and emerging markets

    Deekshita Allavarapu, Analyst for GBI Research says "Emerging markets have substantially driven the growth of generics despite the US being a dominant geography". One example is India, where a significant number of pharmaceutical companies have exhibited advanced technological capabilities coupled with lower marketing and manufacturing costs.

    Deekshita explains further: “Despite emerging economies having relatively lower healthcare spending than developed economies, their healthcare costs are expected to significantly rise in the near future, driven by the adoption or expansion of universal healthcare and a growing incidence of lifestyle diseases.

    In countries such as China, obesity and diabetes are on the rise and disposable incomes are increasing through the expansion of the middle classes.

    "In this way, the adoption of generic drugs is very likely to be seen as a strategy to control costs, given the potential savings these types of drugs can represent.”

    So the future of generic drugs will be dominated by India and China... lets see!

    2017 Update : India is now the largest provider of generic drugs to worldwide markets and has the most number of FDA inspected manufacturing plants outside the U.S.A.

    Other posts of interest

    The rise of the Indian generic drug industry - affordable Indian generics

    What lies ahead in the generic drug market - Future generics

    How will this impact you?

    We see this as great news for consumers, since generic drugs produced in these emerging countries tend to be significantly cheaper than those produced in the USA.

    Also increased generic drugs competition can only be good news for consumers as it offers more choice and accessibility.

  • Pharma companies move into generic drugs market

    The global generic drug industry has witnessed an almost decade-long sales euphoria and volumes and sales growth of prescription generic drugs continued to increase in 2009.

    In the 12 months ended September 2009, global prescription sales growth of generic drugs climbed by 7.7%, up from 3.6% in 2008, according to US-based health care information and consulting company IMS Health. This compares with the 5.7% growth seen within the overall global pharmaceutical universe last year, says Doug Long, vice-president, industry relations at IMS Health.

    During that 12-month period, global generic products generated $83bn (€59.8bn) in audited sales, according to IMS. US market data provider BCC Research estimates that the global market was worth $84bn in 2009.

    "The global industry virtually had 10 years in a row of good growth - not only in prescriptions but also in sales," says Long. "All the dynamics of the generics industry were strong and it seems to have even prospered more during the economic slowdown."

    Generics now account for 72% of the total US pharmaceutical market volume, reaching an all-time high in 2009, he adds. However, they still only account for 17% of total sales, despite generics sales having more than tripled since 2000. In the 12 months ended November 2009, the US generics market was valued by IMS at $31bn. BCC Research estimates the US market in 2009 at $34bn.

    BCC analyst Paul Evers notes continued volatility. "The demand for generics is increasing steadily because of pressure to control health care costs. But at the same time, fierce price competition is resulting in slashed profit margins for participating companies," he says. "A major growth driver for the generics sector is that several blockbuster pharmaceutical brands are coming off patent and therefore open to generic competition."

    BCC notes that Israel-based Teva Pharmaceutical Industries‘ (18% global market share), Switzerland-headquartered Novartis‘s US generics business, Sandoz (10%), and both US-based Mylan (6%), and Watson (6%) are leading generics manufacturers, already occupying 40% of the global market. IMS estimates that sales from the top 10 US generic players grew at an average of 13.2% last year.

    Source: http://www.icis.com/Articles/2010/02/15/9333169/generic-drugs-sales-continue-to-climb.html


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