Generic Oral Liquid Drug Dosage Forms Evolving as Competitors Seek Opportunities

(Amherst, NH) – The generic oral liquid dosage form drug segment is a rapidly evolving and fluid environment that has been a challenge to decision makers attempting to map strategies for success in this segment. Generic drugs are re-shaping the pharmaceutical industry, and the pace of activity shows no signs of slowing.

There are currently 309 distinct APIs for which there is at least one approved generic oral liquid dosage form ANDA. These 309 APIs account for 1,083 approved ANDAs. Including all approved doses, the current universe of generic oral liquid dosage forms consists of 1,283 unique solution, suspension and syrup products. These products are marketed and supplied by 282 companies. Competition among the various drug and therapeutic classes is uneven, with the top eight segments accounting for a disproportionate level of activity and revenue. Understanding the underlying factors affecting business performance is key to attaining financial targets.

As competition among generics suppliers for new products accelerates and would-be ANDA filers become increasingly aggressive in attempting to identify future opportunities, their ANDA filing strategies have come to reflect this. It’s is no longer uncommon for the owners of brand drug NDAs to find a list of tentative ANDA approvals in the FDA queue as their patent and/or exclusivity protection comes to an end.

The provisions of the Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Amendments) which govern the generic drug approval process give 180 days of marketing exclusivity to certain generic drug applicants. The 180-day generic drug exclusivity provision is one component of the complex patent listing and certification process, which also provides for a 30-month stay on generic drug approvals while certain patent infringement issues are litigated. So-called P (iv) filings are now routine for most brand drugs, requiring NDA holders to decide on a legal strategy to protect their brand often many years before existing patents for their products are due to expire.

Generic oral liquid dosage forms are detailed in a new and comprehensive report researched and written by Greystone Research Associates. Generic Oral Liquid Dosage Forms: Products, Markets, Players and Outlook analyzes generic oral solution, suspension and syrup products and the indications and therapeutic classes in which they compete. The report includes analysis of competitive factors, ANDA filing strategies, market growth trends and strategic and economic factors, and provides assessments of the market presence of sector participants.

More information is available at http://www.greystoneassociates.org



Source: Greystone Research Associates

About Greystone

Greystone Research Associates is a medical technology consulting firm focused on the areas of medical market strategy, product commercialization, venture development, and market research. We assist medical and healthcare market participants in achieving their business objectives through the creation of detailed development strategies, product commercialization programs, and comprehensive market and technology research and analysis. Our market research publications are designed, researched and written to provide timely and insightful information and data on focused market segments, with the aim of providing market participants with the essential knowledge to refine and execute their marketing plans and financial targets.

Contact:

Mark Smith
Greystone Research Associates
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Amherst, NH 03031 USA
Voice: 603-595-4340
Fax: 603-218-7020
www.greystoneassociates.org

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