(PharmaNewsWire.Com, March 19, 2018 ) Generic drugs are copies of branded drugs that have same composition, effects, risks, and functions as the original drug but at a lower price and usually subject to government regulations in the countries where they are dispensed. Generic drugs are also known as abbreviated drugs. To sell a generic drug manufacturing company must submit an Abbreviated New Drug Application for approval. The Drug Price Competition and Patent Term Restoration Act of 1984, mostly known as the Hatch-Waxman Act, made ANDAs feasible by creating a compromise in the drug industry. Generic drug companies have obtained greater access to the market for prescription drugs, and branded companies have obtained restoration of patent life for their drugs lost during FDA's approval process.
Generic drugs market is segmented into Biosimilars, Simple generic and Super generic. Based on therapeutic drugs, they are further segmented into Cardiovascular products, anti infective products, anti-arthritis drugs, central nervous system drugs, anti-cancer drugs, respiratory products, and others. Super generics are sold at higher price than their pure generic counterpart. Super generics account for 18% of total spending on generic drugs. But biosimilars are comparatively cost effective even among generic drugs. Bio similar drugs are expected to have significant growth during the forecast period.
Drugs which are lifesaving and there patent gets expired fall under the category of generic drugs. The major factor that is giving lead to generic drugs compared to original drugs is its cost effectiveness.
The key challenge restraining the market is rigid rules setup by FDA for approval of these drugs and the threat of counterfeit drugs.
In Generic drugs market there are many vendors some of them Ranbaxy Laboratories, Ltd, Actavis, Mylan, Inc., Industries, Ltd., Dr. Reddy's Laboratories, Par Pharmaceutical, Inc., Sandoz International GmbH, Hospira, Inc., Apotex, Inc., Watson Pharmaceuticals, Ltd., Teva Pharmaceutical and others.
Regional Overview
North America dominates the market globally followed by Europe and Asia-pacific. Asia-Pacific is expected to grow significantly because of developing countries like India, China and Japan establishing pathways for approvals of generic drugs and their untapped market potential.
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