Canada-based pharmaceutical company Duchesnay filed a suit against Dublin headquartered generic maker, Actavis on July 11, 2014, in the New Jersey District seeking to prevent Actavis from commercializing its ANDA product prior to the expiration of Duchesnay’s patent US6340695 entitled ‘Rapid onset formulation’. This action formally initiates the patent challenge process under the Hatch-Waxman Act, which grants a 30-month stay to drug companies that file suit against generic manufactures challenging their patents.
The patent was issued by USPTO to inventor Eric Gervais on Jan 22, 2002 and expires[i] by Jun 21, 2021. Duchesnay is the current assignee[ii] of the ‘695 patent (source: MaxVal’s Assignment Database).
Actavis filed an Abbreviated New Drug Application (ANDA) no. 205811 with the FDA seeking approval to market doxylamines and pyridoxine hydrochloride delayed-release tablets, 10 mg/10 mg. The complaint futher added that Actavis’s generic product labeled the same indications and dosage as the drug, Diclegis.
Duchesnay is the current holder[iii] of Diclegis (source: Patent Marker) with NDA no. 021876, approved by FDA on Apr 08, 2013. The active ingredients of the drug include: doxylamine succinate and pyridoxine hydrochloride.
Duchesnay alleged that Actavis' ANDA product is a generic version of Duchesnay‘s Diclegis, which is indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management.
See 2:14-cv-04384 for more details. To get alerts on cases filed/closed, subscribe to our Litigation Alerts.
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[i] Expected expiration date. Patent Term Estimator is a free web-based tool that automatically calculates patent terms and expiration dates for U.S. utility patents.
[ii] MaxVal offers Patent Assignment Alert service where subscribers receive email alerts when assignments relating to target applications, patents or entities of interest are recorded.
[iii] Patent Marker provides an online environment where patentees can virtually mark products and search products for patent-related information.