subject: Controlled release technology to become an international generic drug company marketing Collection - Controlled Release - pharmaceutical industries [print this page] Controlled release technology to become an international generic drug company marketing Collection - Controlled Release - pharmaceutical industries
Global market research firm Espicom Business Consulting 8 announced the end of a paper entitled "Controlled Release of new opportunities for generics," the report. Report that the international generics business increased emphasis on controlled release technology, and generic companies as an important way to achieve competitive advantage.
Report points out that the reason why the generic pharmaceutical companies interested in controlled release formulations, partly because of the impending loss of patent protection, the increasing number of controlled release drugs. Moreover, sustained and controlled release drugs with the technical barriers to making this formula is difficult to develop, manufacture and sale of controlled release pharmaceutical enterprises less competitive, sustained and controlled release formulations than immediate release pricing too high. 2008 sales of controlled release of drugs has more than 15 billion U.S. dollars.
Report noted that some pharmaceutical companies have taken early in the product life cycle began to concern the development of controlled release dosage form, rather than product patents expiring in the development of controlled release formulation only the beginning. While some companies have begun listing immediate release and sustained release of two formulations.
Although many controlled release formulations are patented, but the U.S. pharmaceutical companies often have to under the "Drug Price Competition and Patent Term Amendment Act" (Hatch-Waxman) that "the fourth paragraph of Certification", and patent validity is often the subject of litigation . Sometimes, before the expiration of the relevant product patents, generic drug manufacturers and innovative manufacturing enterprises will enter into an agreement to allow generic drug companies limited the introduction of generic drugs. Agreement by restricting generic competition and the loss of revenue, will benefit from innovative drug companies, drug companies make generic products enter the market as soon as possible to shorten the competition period.
Recently, Wyeth's antidepressant drug EffexorXR (active ingredient as venlafaxine) has become the subject of patent litigation. In many enterprises EffexorXR simple generic new drug application submitted to the FDA (ANDA), the Wyeth company has launched a number of patent rights protection litigation. As of July, Sandoz Germany, the United States Mylan, India, Wockhardt and Torrent, Canada, and Apotex launched Biovail patent litigation is still pending, and Impax in the United States, California and Pennsylvania, the company Mylan companies received venlafaxine Xin generic test for controlled release capsules.
FDA also approved the company's U.S. Osmotica controlled release tablets of venlafaxine new drug application, but on the Osmotica company Wyeth has launched a patent infringement lawsuit, and finally by granting the company control of venlafaxine slow the right way release tablets of the drug in exchange for exclusive marketing rights. Meanwhile, Wyeth also Impax Corporation, India Lupin, the United States Anchen Pharmaceuticals and Teva Pharmaceutical Industries of Israel filed a patent infringement lawsuit.
Recent years, a large number of patent medicines due to generic does provide an excellent opportunity for development. 2007 alone, there are 35 kinds of world heavyweight drug patents expire, set aside as much as 80 billion U.S. dollars worth of the market. It is estimated that 2009 to 2013, the global generics market will be an annual increase of more than 9% growth in Asia will reach 12%, well above the global pharmaceutical industry, the overall pace of development.
In the generics industry a threat to the interests of the patent medicine companies, pharmaceutical giants have launched large-scale response to patent litigation patent challenges, as the largest generics consuming nations of China, he became a large number of vendors compete for place. It is expected that by 2012, China will become world's second largest generics market, compound annual growth rate of 14%.
Present, generic drug companies are the main threats facing the involvement of multinational pharmaceutical companies, and small Chinese enterprises and disorderly competition in existence. But we also have their own advantages and opportunities: First, lower production costs, most generic drug production enterprises have certain strength and the advantage; followed by the new opportunities brought about by the medical reform, the Government encourages the use of generic drugs to save medical costs; the third is "blockbuster" drug patent expiration opportunity. If through mergers and acquisitions, building strategic alliances to expand business scale and enhance their competitiveness, and appropriate technological transformation and innovation, then, companies do not invest too much money, you can significantly improve the profitability of generic drugs.
