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Last Updated: March 29, 2024

Doxepin hydrochloride - Generic Drug Details


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What are the generic sources for doxepin hydrochloride and what is the scope of freedom to operate?

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
E2Bio Life Sciences, LLCPhase 1/Phase 2
Hematology Center after Prof. R. YeolyanPhase 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
Amneal Pharms Co DOXEPIN HYDROCHLORIDE doxepin hydrochloride CAPSULE;ORAL 207482-004 Jun 28, 2017 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Chemistry Hlth DOXEPIN HYDROCHLORIDE doxepin hydrochloride CAPSULE;ORAL 211619-003 Mar 9, 2021 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Currax SILENOR doxepin hydrochloride TABLET;ORAL 022036-001 Mar 17, 2010 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Appco DOXEPIN HYDROCHLORIDE doxepin hydrochloride CAPSULE;ORAL 214908-004 Apr 1, 2021 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Pfizer SINEQUAN doxepin hydrochloride CAPSULE;ORAL 016798-002 Approved Prior to Jan 1, 1982 DISCN Yes 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
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
World Intellectual Property Organization (WIPO) 2007142810 ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2007136845 ⤷  Try a Trial
Canada 2687118 PROCEDES D'UTILISATION DE DOXEPINE FAIBLEMENT DOSEE POUR AMELIORER LE SOMMEIL (METHODS OF USING LOW-DOSE DOXEPIN FOR THE IMPROVEMENT OF SLEEP) ⤷  Try a Trial
Canada 2721133 FORMULATIONS DE DOXEPINE A FAIBLE DOSE ET PROCEDE DE PREPARATION ET D'UTILISATION DE CELLE-CI (LOW-DOSE DOXEPIN FORMULATIONS AND METHODS OF MAKING AND USING THE SAME) ⤷  Try a Trial
Japan 2018044006 睡眠改善のための低用量ドキセピンの使用法 (METHODS OF USING LOW DOSE DOXEPIN FOR SLEEP IMPROVEMENT) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.