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Last Updated: October 7, 2022

DOXEPIN HYDROCHLORIDE Drug Patent Profile


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Which patents cover Doxepin Hydrochloride, and what generic alternatives are available?

Doxepin Hydrochloride is a drug marketed by Ajanta Pharma Ltd, Alembic Pharms Ltd, Amneal Pharms Co, Appco, Aurobindo Pharma Ltd, Chartwell Rx, Contract Pharmacal, Dava Pharms Inc, Edenbridge Pharms, Epic Pharma Llc, Jubilant Cadista, Lannett Co Inc, Leading Pharma Llc, Mankind Pharma, MSN, Mylan Pharms Inc, New River, Par Pharm, Purepac Pharm, Quantum Pharmics, Sandoz, Sun Pharm Industries, Taro Pharm Inds Ltd, Watson Labs, Watson Labs Teva, Pharm Assoc, Teva Pharms, Wockhardt Bio Ag, Actavis Elizabeth, Rk Pharma, and Strides Pharma. and is included in sixty-seven NDAs.

The generic ingredient in DOXEPIN HYDROCHLORIDE is doxepin hydrochloride. There are seven drug master file entries for this compound. Thirty-six 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

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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

DOXEPIN HYDROCHLORIDE is protected by zero US patents and one FDA Regulatory Exclusivity.

FDA Regulatory Exclusivity protecting DOXEPIN HYDROCHLORIDE

COMPETITIVE GENERIC THERAPY
Exclusivity Expiration: See Plans and Pricing

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Msn DOXEPIN HYDROCHLORIDE doxepin hydrochloride CAPSULE;ORAL 215113-004 Jun 24, 2022 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Quantum Pharmics DOXEPIN HYDROCHLORIDE doxepin hydrochloride CAPSULE;ORAL 072375-001 Mar 15, 1989 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Dava Pharms Inc DOXEPIN HYDROCHLORIDE doxepin hydrochloride CAPSULE;ORAL 071676-001 Jan 5, 1988 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Contract Pharmacal DOXEPIN HYDROCHLORIDE doxepin hydrochloride CAPSULE;ORAL 213474-002 Jul 28, 2020 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 016987-004 Approved Prior to Jan 1, 1982 See Plans and Pricing See Plans and Pricing
New River DOXEPIN HYDROCHLORIDE doxepin hydrochloride CAPSULE;ORAL 016987-001 Approved Prior to Jan 1, 1982 See Plans and Pricing See Plans and Pricing
New River DOXEPIN HYDROCHLORIDE doxepin hydrochloride CAPSULE;ORAL 016987-006 Approved Prior to Jan 1, 1982 See Plans and Pricing See Plans and Pricing
New River DOXEPIN HYDROCHLORIDE doxepin hydrochloride CAPSULE;ORAL 016987-003 Approved Prior to Jan 1, 1982 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

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