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Generic Growth Strategies - Manufacturers to Increase Focus on Super Generics and Biosimilars to Dri
Generic Growth Strategies - Manufacturers to Increase Focus on Super Generics and Biosimilars to Dri
Patent Expiries in Near Future Will Drive Generics’ Growth
London,
London,
United Kingdom
(prbd.net)
11/05/2011
The US generic industry has grown considerably ever since the enactment of the Hatch-Waxman Act, in 1984 which provided substantial power to generic companies to challenge drug patents and avail the benefit of a 180-day exclusivity period given to the first-to-file generic company. Since then, generic companies have used this Act to challenge the patents of branded drugs. Moreover, healthcare providers are under pressure from rising healthcare costs and prescription drug spending in particular. With increasing prices for the prescription drugs, healthcare providers such as federal and state-funded programs, employers, insurance companies, and even end-consumers under the co-pay agreements, are feeling the economic pressure. In such an environment, generic drugs provide several advantages over prescription drugs.
Available data from the Center for Drug Evaluation and Research (CDER) and U.S Food and Drug Administration (FDA) shows that since 2005 there had been 588 first-time generic drug approvals by 2010 in the US. First-time generics are defined as those drug products that are being approved for the first time as generic drug products and are therefore novel generic products to the market. The year 2009 saw the most first-time generic drug approvals since 2005, with 112 generic dug products approvals. There were 93 generic drug approvals in 2010. On average, there have been 98 first-time generic drug products approvals each year between 2005 and 2010.
Pharmaceutical products are not protected by only one patent, but by many. Sometimes a molecule is protected twice, once in a racemic form and once as an enantiomer; a specific salt may also be protected as well as a crystalline form (or lack of) for that salt. Each drug is guarded with more than one patent application, which in turn helps in extending patent life.
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GBI Research, the leading business intelligence provider, has released its latest research
“Generic Growth Strategies - Manufacturers to Increase Focus on Super Generics and
Biosimilars to Drive Revenues”. It provides a comprehensive overview of the generic drugs market, analysis of upcoming noteworthy patent expirations, and trends and issues facing the generics market. The report delves into much detail on the current landscape; changes that have structured the generic drugs market in the last 30 years; and the reason behind the players’ urgency in developing and implementing generic growth strategies. The report also contains impact analysis of the regulatory landscape in the major geographies pertaining to the generic drugs market. Major strategies adopted by the leading companies in the generic drugs market have been analyzed in much detail, along with an elaborate company portfolio and strategic analysis of leading generic players. This report is built using data and information sourced from proprietary databases, primary and secondary research and in-house analysis by GBI Research’s team of industry experts.
The pharmaceutical industry is going to experience major patent expiries during 2011-2014. Although generic drug companies are expected to experience lucrative opportunities due to the impending patent expiries, they are gearing up to face competition from entities such as innovator companies vying for a share of the generic drugs market, and intense competition from other generic companies.
GBI Research has found that the pharmaceutical industry in general and the generics sector in particular have turned out to be highly competitive of late. There is rampant consolidation; novel business models are developing such as hybrid models between generic and innovator companies; and generics companies partnering with third-party sales to increase growth. Such joint ventures and co-operations are being adapted to leverage each partner’s strengths. The benefits from these partnerships are wide ranging for the generics companies, from higher access to research and development (R&D) capabilities and innovator drugs access to wider penetration in new markets.
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