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Last Updated: March 28, 2024

DOXEPIN HYDROCHLORIDE - Generic Drug Details


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What are the generic sources for doxepin hydrochloride and what is the scope of patent protection?

Doxepin hydrochloride is the generic ingredient in four branded drugs 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, Pfizer, Pharm Assoc, Pharmobedient Cnsltg, Teva Pharms, Amneal, Mylan, Actavis Elizabeth, Rk Pharma, Strides Pharma, Zydus Pharms, and Currax, and is included in seventy-nine NDAs. There are fifteen 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 is one drug master file entry for doxepin hydrochloride. Forty-eight suppliers are listed for this compound.

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
Par Pharm DOXEPIN HYDROCHLORIDE doxepin hydrochloride CAPSULE;ORAL 071422-006 Nov 9, 1987 AB RX No Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Chartwell Rx DOXEPIN HYDROCHLORIDE doxepin hydrochloride CAPSULE;ORAL 210268-005 Sep 4, 2020 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Currax SILENOR doxepin hydrochloride TABLET;ORAL 022036-002 Mar 17, 2010 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Mylan Pharms Inc DOXEPIN HYDROCHLORIDE doxepin hydrochloride CAPSULE;ORAL 070791-004 May 13, 1986 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Currax SILENOR doxepin hydrochloride TABLET;ORAL 022036-002 Mar 17, 2010 AB RX Yes Yes ⤷  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
Currax SILENOR doxepin hydrochloride TABLET;ORAL 022036-001 Mar 17, 2010 ⤷  Try a Trial ⤷  Try a Trial
Currax SILENOR doxepin hydrochloride TABLET;ORAL 022036-002 Mar 17, 2010 ⤷  Try a Trial ⤷  Try a Trial
Currax SILENOR doxepin hydrochloride TABLET;ORAL 022036-002 Mar 17, 2010 ⤷  Try a Trial ⤷  Try a Trial
Currax SILENOR doxepin hydrochloride TABLET;ORAL 022036-002 Mar 17, 2010 ⤷  Try a Trial ⤷  Try a Trial
Currax SILENOR doxepin hydrochloride TABLET;ORAL 022036-002 Mar 17, 2010 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for DOXEPIN HYDROCHLORIDE

Country Patent Number Title Estimated Expiration
Canada 2693992 METHODES DESTINEES A AMELIORER LA PHARMACOCINETIQUE DE LA DOXEPINE (METHODS OF IMPROVING THE PHARMACOKINETICS OF DOXEPIN) ⤷  Try a Trial
Japan 2013237694 METHOD OF USING LOW-DOSE DOXEPIN FOR IMPROVEMENT OF SLEEP ⤷  Try a Trial
European Patent Office 2026792 FORMULATIONS DE DOXÉPINE À FAIBLE DOSE, INCLUANT DES FORMULATIONS BUCCALES, SUBLINGUALES ET À DISSOLUTION RAPIDE, ET LEURS UTILISATIONS POUR TRAITER L'INSOMNIE (LOW DOSE DOXEPIN FORMULATIONS, INCLUDING BUCCAL, SUBLINGUAL AND FASTMELT FORMULATIONS, AND USES OF THE SAME TO TREAT INSOMNIA) ⤷  Try a Trial
Canada 2687124 FORMULATIONS DE DOXEPINE A FAIBLE DOSE, INCLUANT DES FORMULATIONS BUCCALES, SUBLINGUALES ET A DISSOLUTION RAPIDE, ET LEURS UTILISATIONS POUR TRAITER L'INSOMNIE (LOW DOSE DOXEPIN FORMULATIONS, INCLUDING BUCCAL, SUBLINGUAL AND FASTMELT FORMULATIONS, AND USES OF THE SAME TO TREAT INSOMNIA) ⤷  Try a Trial
Japan 2009537554 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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