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Serving leading biopharmaceutical companies globally:

US Army
Express Scripts
Medtronic
US Department of Justice
Argus Health
Federal Trade Commission
AstraZeneca
Fuji
Colorcon
Accenture

Generated: January 17, 2018

DrugPatentWatch Database Preview

Doxepin hydrochloride - Generic Drug Details

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

Doxepin hydrochloride
is the generic ingredient in four branded drugs marketed by Amneal Pharms Co, Dava Pharms Inc, Mylan Pharms Inc, New River, Par Pharm, Purepac Pharm, Quantum Pharmics, Sandoz, Sun Pharm Industries, Watson Labs, Watson Labs Teva, Pfizer, Pharm Assoc, Silarx, Teva Pharms, Wockhardt, Actavis Elizabeth, and Pernix Theraps Llc, and is included in sixty NDAs. There are seven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Doxepin hydrochloride has fifteen patent family members in four countries.

There are seven drug master file entries for doxepin hydrochloride. Thirty suppliers are listed for this compound. There are two tentative approvals for this compound.
Summary for doxepin hydrochloride
Pharmacology for doxepin hydrochloride
Medical Subject Heading (MeSH) Categories for doxepin hydrochloride
Tentative approvals for DOXEPIN HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
➤ Subscribe➤ Subscribe3MGTABLET; ORAL
➤ Subscribe➤ Subscribe6MGTABLET; ORAL
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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
Mylan Pharms Inc DOXEPIN HYDROCHLORIDE doxepin hydrochloride TABLET;ORAL 202337-002 Jan 20, 2016 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Sun Pharm Industries DOXEPIN HYDROCHLORIDE doxepin hydrochloride CAPSULE;ORAL 071654-001 Feb 18, 1988 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Watson Labs DOXEPIN HYDROCHLORIDE doxepin hydrochloride CAPSULE;ORAL 072985-001 Mar 29, 1991 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Pernix Theraps Llc SILENOR doxepin hydrochloride TABLET;ORAL 022036-001 Mar 17, 2010 AB RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Mylan Pharms Inc DOXEPIN HYDROCHLORIDE doxepin hydrochloride CAPSULE;ORAL 070791-004 May 13, 1986 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Watson Labs DOXEPIN HYDROCHLORIDE doxepin hydrochloride CAPSULE;ORAL 070955-001 May 15, 1986 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Teva Pharms DOXEPIN HYDROCHLORIDE doxepin hydrochloride CONCENTRATE;ORAL 071609-001 Nov 9, 1987 AA RX No Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Pfizer SINEQUAN doxepin hydrochloride CAPSULE;ORAL 016798-003 Approved Prior to Jan 1, 1982 DISCN Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Pernix Theraps Llc SILENOR doxepin hydrochloride TABLET;ORAL 022036-001 Mar 17, 2010 AB RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Par Pharm DOXEPIN HYDROCHLORIDE doxepin hydrochloride CAPSULE;ORAL 071697-001 Nov 9, 1987 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for doxepin hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pernix Theraps Llc SILENOR doxepin hydrochloride TABLET;ORAL 022036-002 Mar 17, 2010 ➤ Subscribe ➤ Subscribe
New River DOXEPIN HYDROCHLORIDE doxepin hydrochloride CAPSULE;ORAL 016987-004 Approved Prior to Jan 1, 1982 ➤ Subscribe ➤ Subscribe
Pfizer SINEQUAN doxepin hydrochloride CAPSULE;ORAL 016798-007 Approved Prior to Jan 1, 1982 ➤ Subscribe ➤ Subscribe
Pernix Theraps Llc SILENOR doxepin hydrochloride TABLET;ORAL 022036-001 Mar 17, 2010 ➤ Subscribe ➤ Subscribe
New River DOXEPIN HYDROCHLORIDE doxepin hydrochloride CAPSULE;ORAL 016987-001 Approved Prior to Jan 1, 1982 ➤ Subscribe ➤ Subscribe
Pernix Theraps Llc SILENOR doxepin hydrochloride TABLET;ORAL 022036-001 Mar 17, 2010 ➤ Subscribe ➤ Subscribe
Pfizer SINEQUAN doxepin hydrochloride CAPSULE;ORAL 016798-002 Approved Prior to Jan 1, 1982 ➤ Subscribe ➤ Subscribe
Pernix Theraps Llc SILENOR doxepin hydrochloride TABLET;ORAL 022036-002 Mar 17, 2010 ➤ Subscribe ➤ Subscribe
Pernix Theraps Llc SILENOR doxepin hydrochloride TABLET;ORAL 022036-002 Mar 17, 2010 ➤ Subscribe ➤ Subscribe
Pernix Theraps Llc SILENOR doxepin hydrochloride TABLET;ORAL 022036-001 Mar 17, 2010 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for doxepin hydrochloride

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
9,463,181 Doxepin isomers and isomeric mixtures and methods of using the same to treat sleep disorders ➤ Subscribe
9,498,462 Doxepin trans isomers and isomeric mixtures and methods of using the same to treat sleep disorders ➤ Subscribe
9,801,847 Doxepin isomers and isomeric mixtures and methods of using the same to treat sleep disorders ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for doxepin hydrochloride

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Novartis
Chubb
UBS
Harvard Business School
Medtronic
QuintilesIMS
Cerilliant
Express Scripts

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 verifification 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.

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