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Doxepin hydrochlorideis the generic ingredient in four branded drugs marketed by Ajanta Pharma Ltd, Alembic Pharms Ltd, Amneal Pharms Co, Appco, Aurobindo Pharma Ltd, Chartwell Rx, Contract Pharmacal, Dava Pharms Inc, Epic Pharma Llc, Lannett Co Inc, Leading Pharma Llc, Mylan Pharms Inc, New River, Par Pharm, Purepac Pharm, Quantum Pharmics, Sandoz, Sun Pharm Industries, Taro Pharm Inds Ltd, Watson Labs, Watson Labs Teva, Pfizer, Pharm Assoc, Teva Pharms, Wockhardt Bio Ag, Mylan, Actavis Elizabeth, Par Pharm Inc, Rk Pharma, and Currax, and is included in sixty-seven NDAs. There are twelve patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.
Doxepin hydrochloride has sixteen patent family members in four countries.
There are seven drug master file entries for doxepin hydrochloride. Thirty-one suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for doxepin hydrochloride
|Drug Master File Entries:||7|
|Finished Product Suppliers / Packagers:||31|
|Raw Ingredient (Bulk) Api Vendors:||69|
|Formulation / Manufacturing:||see details|
|Patent Litigation and PTAB cases:||See patent lawsuits and PTAB cases for doxepin hydrochloride|
|What excipients (inactive ingredients) are in doxepin hydrochloride?||doxepin hydrochloride excipients list|
|DailyMed Link:||doxepin hydrochloride at DailyMed|
Recent Clinical Trials for doxepin hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
|University of Balamand||Phase 4|
|Haining Health-Coming Biotech Co., Ltd.||Phase 2|
Generic filers with tentative approvals for DOXEPIN HYDROCHLORIDE
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for doxepin hydrochloride
|Drug Class||Tricyclic Antidepressant |
Medical Subject Heading (MeSH) Categories for doxepin hydrochloride
|Country||Patent Number||Estimated Expiration|
|Canada||2721133||⤷ Free Forever Trial|
|Japan||2016041757||⤷ Free Forever Trial|
|Canada||2687118||⤷ Free Forever Trial|
|Japan||2009537553||⤷ Free Forever Trial|
|World Intellectual Property Organization (WIPO)||2007136845||⤷ Free Forever Trial|
|World Intellectual Property Organization (WIPO)||2008128115||⤷ Free Forever Trial|
|World Intellectual Property Organization (WIPO)||2008011150||⤷ Free Forever Trial|
|>Country||>Patent Number||>Estimated Expiration|
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