Schering-Plough Announces Resolution of Litigations on U.S. Marketing of Generic Forms of Solid Oral Dosage Forms of CLARINEX(R)
12 Août 2009 - 12:08AM
PR Newswire (US)
KENILWORTH, N.J., Aug. 11 /PRNewswire-FirstCall/ -- Schering-Plough
Corporation (NYSE:SGP) today announced an agreement with Orchid
Chemicals & Pharmaceuticals Ltd. and Orgenus Pharma, Inc.
("Orchid"), related to the generic manufacturing of certain
formulations of CLARINEX (desloratadine). The agreement marks the
end of all pending litigations filed and consolidated since 2006 in
the U.S. District Court for the District of New Jersey against
several generic drug manufacturing companies that had sought
approval to market solid oral dosage forms of desloratadine
products in the United States as generic brands prior to the
expiration of certain Schering Corporation patents. This agreement
resolves all pending patent infringement litigation filed by
Schering Corp. against Orchid and will allow Orchid to introduce a
generic version of the CLARINEX brand REDITABS
(orally-disintegrating tablets) to be introduced into the U.S.
market on January 1, 2012, and CLARINEX brand 5 milligram tablets
to be introduced on July 1, 2012. Schering holds various patents
related to CLARINEX that extend to 2022. Beginning in September of
2006, Schering Corp. filed complaints for patent infringement
against generic drug manufacturing companies that sought U.S.
marketing rights for generic versions of CLARINEX tablets, CLARINEX
REDITABS and/or CLARINEX-D12/-D 24 Extended Release Tablets. Since
then, consent orders have been entered and/or settlements now have
been reached in the cases against Anchen Pharmaceuticals, Inc.,
Belcher Pharmaceuticals, Inc., Caraco Pharmaceutical Laboratories,
Ltd., Dr. Reddy's Laboratories, Inc. and Dr. Reddy's Laboratories,
Ltd., GeoPharma, Inc., Glenmark Pharmaceuticals Inc., USA, Glenmark
Pharmaceuticals, Ltd., Lupin Pharmaceuticals, Inc. and Lupin Ltd.,
Mylan Pharmaceuticals Inc., Orchid Chemicals & Pharmaceuticals
Ltd. and Orgenus Pharma, Inc., Perrigo Co., L. Perrigo, Co.,
Ranbaxy Inc., Ranbaxy Laboratories Limited, Sandoz Inc., Sun
Pharmaceutical Industries Ltd., Watson Laboratories, Inc. and
Watson Pharmaceuticals, Inc. and Zydus Pharmaceuticals, USA, Inc.,
thereby resolving the actions between Schering Corp. and these
parties. The terms agreed to with Orchid on timing of market
introduction in the U.S. will apply retroactively as appropriate to
the previously negotiated agreements. Also, the Orchid agreement
provides for potential modification of its terms. The law suit is
still pending until an order of dismissal is signed by the court.
Under current law, the agreement can be reviewed by the U.S.
Federal Trade Commission and U.S. Department of Justice. CLARINEX
brand 5 mg tablets and REDITABS, a nonsedating antihistamine,
offers relief from seasonal allergic rhinitis and perennial
allergic rhinitis, as well as chronic idiopathic urticaria, or
hives of unknown cause. CLARINEX-D 24 Extended Release Tablets is
the only once-daily prescription antihistamine and decongestant
combination treatment on the market to provide 24-hour relief of
nasal and non-nasal allergy symptoms. Total U.S. sales for CLARINEX
products were $295 million in 2008. Schering-Plough is an
innovation-driven, science-centered global health care company.
Through its own biopharmaceutical research and collaborations with
partners, Schering-Plough creates therapies that help save and
improve lives around the world. The company applies its
research-and-development platform to human prescription, animal
health and consumer health care products. Schering-Plough's vision
is to "Earn Trust, Every Day" with the doctors, patients, customers
and other stakeholders served by its colleagues around the world.
The company is based in Kenilworth, N.J., and its Web site is
http://www.schering-plough.com/. DATASOURCE: Schering-Plough
Corporation CONTACT: Media: Fred Malley, +1-908-298-7428;
Investors: Janet M. Barth, or Joe Romanelli, +1-908-298-7436 Web
Site: http://www.schering-plough.com/
Copyright
Schering Plough (NYSE:SGP)
Graphique Historique de l'Action
De Déc 2024 à Jan 2025
Schering Plough (NYSE:SGP)
Graphique Historique de l'Action
De Jan 2024 à Jan 2025