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Last Updated: March 29, 2024

DOXEPIN HYDROCHLORIDE Drug Patent Profile


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When do Doxepin Hydrochloride patents expire, and what generic alternatives are available?

Doxepin Hydrochloride is a drug marketed by Ajanta Pharma Ltd, Alembic, Amneal Pharms Co, Appco, Aurobindo Pharma Ltd, Chartwell Rx, Chemistry Hlth, Contract Pharmacal, Dava Pharms Inc, Edenbridge Pharms, Epic Pharma Llc, Jubilant Cadista, Lannett Co Inc, Leading, Mankind Pharma, Micro Labs, MSN, Mylan Pharms Inc, New River, Par Pharm, Purepac Pharm, Quantum Pharmics, Sandoz, Sun Pharm Industries, Taro, Unique Pharm, Watson Labs, Watson Labs Teva, Zydus Lifesciences, Pharm Assoc, Pharmobedient Cnsltg, Teva Pharms, Amneal, Actavis Elizabeth, Rk Pharma, Strides Pharma, and Zydus Pharms. and is included in seventy-five NDAs.

The generic ingredient in DOXEPIN HYDROCHLORIDE is doxepin hydrochloride. There are seven drug master file entries for this compound. Forty-eight suppliers are listed for this compound. Additional details are available on the doxepin hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Doxepin Hydrochloride

A generic version of DOXEPIN HYDROCHLORIDE was approved as doxepin hydrochloride by MYLAN PHARMS INC on May 13th, 1986.

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Drug patent expirations by year for DOXEPIN HYDROCHLORIDE
Recent Clinical Trials for DOXEPIN HYDROCHLORIDE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Hematology Center after Prof. R. YeolyanPhase 1/Phase 2
E2Bio Life Sciences, LLCPhase 1/Phase 2
State University of New York - Upstate Medical UniversityPhase 3

See all DOXEPIN HYDROCHLORIDE clinical trials

Pharmacology for DOXEPIN HYDROCHLORIDE
Medical Subject Heading (MeSH) Categories for DOXEPIN HYDROCHLORIDE
Paragraph IV (Patent) Challenges for DOXEPIN HYDROCHLORIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
SILENOR Tablets doxepin hydrochloride 3 mg and 6 mg 022036 2 2010-09-16

US Patents and Regulatory Information for DOXEPIN HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Micro Labs DOXEPIN HYDROCHLORIDE doxepin hydrochloride CAPSULE;ORAL 217688-004 Jun 27, 2023 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Purepac Pharm DOXEPIN HYDROCHLORIDE doxepin hydrochloride CAPSULE;ORAL 072387-001 Sep 8, 1988 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Dava Pharms Inc DOXEPIN HYDROCHLORIDE doxepin hydrochloride CAPSULE;ORAL 071685-001 Jan 5, 1988 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for DOXEPIN HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
New River DOXEPIN HYDROCHLORIDE doxepin hydrochloride CAPSULE;ORAL 016987-001 Approved Prior to Jan 1, 1982 ⤷  Try a Trial ⤷  Try a Trial
New River DOXEPIN HYDROCHLORIDE doxepin hydrochloride CAPSULE;ORAL 016987-002 Approved Prior to Jan 1, 1982 ⤷  Try a Trial ⤷  Try a Trial
New River DOXEPIN HYDROCHLORIDE doxepin hydrochloride CAPSULE;ORAL 016987-004 Approved Prior to Jan 1, 1982 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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