A generic drug is a duplicate copy of original branded drug, which has same dosage form, active pharma ingredients (API), strength, route of administration, and also same intended use as the branded one. Regulatory authorities and governments have mandated that an authorized generic drug has to medicinally correspond to the branded drug and sanctioned as an Abbreviated New Drug Application (ANDA) by the Food and Drug Administration (FDA). An authorized generic is the branded company’s individual product, but repackaged and marketed as generic drug either via subsidiary or third party. These are already approved as a New Drug Application by the FDA, only they are promoted via private label. The authorized generics market grew rapidly in the past few years as these provide consumers with branded quality drugs at generic prices. Presently, there is a growing trend of original maker giving approvals to a subsidiary or a private label distribution company to sell its brand name drug as a generic drug at a subsequently low price.
An example of authorized generic drug is Azithromycin Pak which is sold under by the company name Greenstone. Pfizer’s original branded drug Z-pak was approved by the FDA. Before patent expiry of Z-pak, Pfizer allowed Greenstone to sell Z-pak using authorized generic name Azithromycin Pak. Greenstone is a wholly owned subsidiary of Pfizer.
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The global authorized generics market is expected to witness strong growth. Authorized generic drugs are priced at significantly discounted rate i.e. 50% to 70% as compared to branded counterparts. Additionally, many of the popular branded drugs of pharma companies are losing patent protection rights, which is also termed as patent cliffs. This would pave the way for entry of new complex generics in the market. These factors are likely to drive the authorized generics market in the near future. Other factors driving the market are health care plans by governments across the world, rapidly increasing cost of branded drugs, and aging populations. On the other hand, possibility of side effects, and lack of regulatory awareness about products and quality management are factors likely to restrain the global authorized generics market.
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The global authorized generics market can be classified based on product type, application, end-user, and region.
In terms of product type, the global authorized generics market can be segmented into biosimilars, simple generic, super generic, and others. Based on applications the market can be classified into cardiovascular, anti-infective, anti-arthritis, central nervous system, anti-cancer, respiratory, and others.
Geographically, the global authorized generics market can be divided into North America, Asia Pacific, Europe, Latin America, and Middle East & Africa. North America accounted for the largest share of the market, primarily due to technological advancements, rise in demand for generic drugs, increase in overall cost of branded drugs, and presence of key players. Europe held a significant share of the market attributed to advancements in generic drugs, rise in various types of cancer, and blood related disorders. Asia Pacific, however, has been exhibiting high growth rate on account of growing demand for generic drugs, rise in geriatric population, increase in disposable income, and government initiatives to support generic drugs. Rapidly rising population in the region has increased demand for better health care and induced both private and government players to meet the demand. Developing economies such as India and China have also made a significant contribution to the rise of the global authorized generics market by focusing on establishing a better health care infrastructure.
Key players in the market are Teva Pharmaceuticals, Sandoz, Allergan, Mylan, Sun Pharmaceuticals, and STADA Arzneimittel. Other prominent vendors in the market are Abbott, Amgen, Apotex, Aspen, AstraZeneca, Aurobindo Pharma, Baxter, Berlin-Chemie, Biocon, Biogen, Boehringer Ingelheim, Celltrion, Cipla, Coherus Biosciences, Dr. Reddy’s Laboratories, Daiichi Sankyo, Eli Lilly and Company, Emcure Pharmaceuticals, Eurofarma Laboratories, Gedeon Richter, Gilead Sciences, and GlaxoSmithKline.