Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

McKinsey
UBS
Mallinckrodt
Citi
Boehringer Ingelheim
AstraZeneca
Healthtrust
Moodys
Teva
Farmers Insurance

Generated: February 18, 2018

DrugPatentWatch Database Preview

DOXEPIN HYDROCHLORIDE - Generic Drug Details

« Back to Dashboard

What are the generic 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 Bio Ag, Actavis Elizabeth, and Pernix Theraps Llc, and is included in sixty NDAs. There are eight 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
➤ Try a Free Trial➤ Try a Free Trial3MGTABLET; ORAL
➤ Try a Free Trial➤ Try a Free Trial6MGTABLET; ORAL
➤ Try a Free Trial➤ Try a Free Trial6MGTABLET; ORAL

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
Pfizer SINEQUAN doxepin hydrochloride CONCENTRATE;ORAL 017516-001 Approved Prior to Jan 1, 1982 DISCN Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Pernix Theraps Llc SILENOR doxepin hydrochloride TABLET;ORAL 022036-002 Mar 17, 2010 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Sun Pharm Industries DOXEPIN HYDROCHLORIDE doxepin hydrochloride CAPSULE;ORAL 071502-001 Feb 18, 1988 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Watson Labs DOXEPIN HYDROCHLORIDE doxepin hydrochloride CAPSULE;ORAL 071763-001 Feb 9, 1988 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Watson Labs DOXEPIN HYDROCHLORIDE doxepin hydrochloride CAPSULE;ORAL 070955-001 May 15, 1986 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Pernix Theraps Llc SILENOR doxepin hydrochloride TABLET;ORAL 022036-001 Mar 17, 2010 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Mylan Pharms Inc DOXEPIN HYDROCHLORIDE doxepin hydrochloride TABLET;ORAL 202337-001 Jan 20, 2016 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Par Pharm DOXEPIN HYDROCHLORIDE doxepin hydrochloride CAPSULE;ORAL 071669-001 Nov 9, 1987 RX No Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
New River DOXEPIN HYDROCHLORIDE doxepin hydrochloride CAPSULE;ORAL 016987-001 Approved Prior to Jan 1, 1982 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Par Pharm DOXEPIN HYDROCHLORIDE doxepin hydrochloride CAPSULE;ORAL 071697-001 Nov 9, 1987 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

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 016987-006 Approved Prior to Jan 1, 1982 ➤ Try a Free Trial ➤ Try a Free Trial
Pernix Theraps Llc SILENOR doxepin hydrochloride TABLET;ORAL 022036-001 Mar 17, 2010 ➤ Try a Free Trial ➤ Try a Free Trial
Pfizer SINEQUAN doxepin hydrochloride CONCENTRATE;ORAL 017516-001 Approved Prior to Jan 1, 1982 ➤ Try a Free Trial ➤ Try a Free Trial
Pfizer SINEQUAN doxepin hydrochloride CAPSULE;ORAL 016798-007 Approved Prior to Jan 1, 1982 ➤ Try a Free Trial ➤ Try a Free Trial
Pernix Theraps Llc SILENOR doxepin hydrochloride TABLET;ORAL 022036-001 Mar 17, 2010 ➤ Try a Free Trial ➤ Try a Free Trial
Pernix Theraps Llc SILENOR doxepin hydrochloride TABLET;ORAL 022036-001 Mar 17, 2010 ➤ Try a Free Trial ➤ Try a Free Trial
Pfizer SINEQUAN doxepin hydrochloride CAPSULE;ORAL 016798-005 Approved Prior to Jan 1, 1982 ➤ Try a Free Trial ➤ Try a Free Trial
New River DOXEPIN HYDROCHLORIDE doxepin hydrochloride CAPSULE;ORAL 016987-001 Approved Prior to Jan 1, 1982 ➤ Try a Free Trial ➤ Try a Free Trial
Pernix Theraps Llc SILENOR doxepin hydrochloride TABLET;ORAL 022036-002 Mar 17, 2010 ➤ Try a Free Trial ➤ Try a Free Trial
Mylan Pharms Inc ZONALON doxepin hydrochloride CREAM;TOPICAL 020126-001 Apr 1, 1994 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

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

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

International Patents for DOXEPIN HYDROCHLORIDE

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Merck
QuintilesIMS
Medtronic
US Department of Justice
Daiichi Sankyo
Boehringer Ingelheim
Express Scripts
Farmers Insurance
McKinsey

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.

botpot