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Generated: October 23, 2017

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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 Sun Pharm Inds, Par Pharm, Purepac Pharm, Teva Pharms, Pfizer, Wockhardt, Silarx, Pharm Assoc, Sandoz, Watson Labs, Mylan Pharms Inc, Quantum Pharmics, Pernix Theraps Llc, Actavis Elizabeth, Dava Pharms Inc, Amneal Pharms Co, New River, and Watson Labs Teva, 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 Generic Name: doxepin hydrochloride

US Patents:7
Tradenames:4
Applicants:18
NDAs:60
Drug Master File Entries: see list7
Suppliers / Packagers: see list30
Bulk Api Vendors: see list42
Clinical Trials: see list2,296
Patent Applications: see list1,635
Therapeutic Class:Dermatological Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:doxepin hydrochloride at DailyMed

Pharmacology for Ingredient: doxepin hydrochloride

Tentative approvals for DOXEPIN HYDROCHLORIDE

Applicant Application No. Strength Dosage Form
u► Subscribe3MGTABLET; ORAL
u► Subscribe6MGTABLET; ORAL
u► Subscribe6MGTABLET; ORAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Watson Labs
DOXEPIN HYDROCHLORIDE
doxepin hydrochloride
CAPSULE;ORAL071238-001Apr 30, 1987DISCNNoNo► Subscribe► Subscribe► Subscribe
Pernix Theraps Llc
SILENOR
doxepin hydrochloride
TABLET;ORAL022036-001Mar 17, 2010ABRXYesNo► Subscribe► Subscribe ► Subscribe
Pfizer
SINEQUAN
doxepin hydrochloride
CAPSULE;ORAL016798-001Approved Prior to Jan 1, 1982DISCNYesNo► Subscribe► Subscribe► Subscribe
Pernix Theraps Llc
SILENOR
doxepin hydrochloride
TABLET;ORAL022036-001Mar 17, 2010ABRXYesNo► Subscribe► SubscribeY ► Subscribe
Wockhardt
DOXEPIN HYDROCHLORIDE
doxepin hydrochloride
CONCENTRATE;ORAL071918-001Jul 20, 1988AARXNoNo► Subscribe► Subscribe► Subscribe
Mylan Pharms Inc
DOXEPIN HYDROCHLORIDE
doxepin hydrochloride
CAPSULE;ORAL070791-002May 13, 1986ABRXNoNo► Subscribe► Subscribe► Subscribe
Purepac Pharm
DOXEPIN HYDROCHLORIDE
doxepin hydrochloride
CAPSULE;ORAL072109-001Dec 28, 1990DISCNNoNo► Subscribe► Subscribe► Subscribe
Purepac Pharm
DOXEPIN HYDROCHLORIDE
doxepin hydrochloride
CAPSULE;ORAL072386-001Sep 8, 1988DISCNNoNo► Subscribe► Subscribe► Subscribe
New River
DOXEPIN HYDROCHLORIDE
doxepin hydrochloride
CAPSULE;ORAL016987-003Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Pfizer
SINEQUAN
doxepin hydrochloride
CAPSULE;ORAL016798-006Approved Prior to Jan 1, 1982DISCNYesNo► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: doxepin hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer
SINEQUAN
doxepin hydrochloride
CAPSULE;ORAL016798-006Approved Prior to Jan 1, 1982► Subscribe► Subscribe
New River
DOXEPIN HYDROCHLORIDE
doxepin hydrochloride
CAPSULE;ORAL016987-006Approved Prior to Jan 1, 1982► Subscribe► Subscribe
Pfizer
SINEQUAN
doxepin hydrochloride
CONCENTRATE;ORAL017516-001Approved Prior to Jan 1, 1982► Subscribe► Subscribe
Pfizer
SINEQUAN
doxepin hydrochloride
CAPSULE;ORAL016798-005Approved Prior to Jan 1, 1982► Subscribe► Subscribe
Pernix Theraps Llc
SILENOR
doxepin hydrochloride
TABLET;ORAL022036-002Mar 17, 2010► Subscribe► Subscribe
Pernix Theraps Llc
SILENOR
doxepin hydrochloride
TABLET;ORAL022036-002Mar 17, 2010► Subscribe► Subscribe
Pernix Theraps Llc
SILENOR
doxepin hydrochloride
TABLET;ORAL022036-002Mar 17, 2010► Subscribe► Subscribe
Pernix Theraps Llc
SILENOR
doxepin hydrochloride
TABLET;ORAL022036-002Mar 17, 2010► Subscribe► Subscribe
Pfizer
SINEQUAN
doxepin hydrochloride
CAPSULE;ORAL016798-007Approved Prior to Jan 1, 1982► Subscribe► Subscribe
New River
DOXEPIN HYDROCHLORIDE
doxepin hydrochloride
CAPSULE;ORAL016987-004Approved Prior to Jan 1, 1982► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: 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
9,463,181Doxepin isomers and isomeric mixtures and methods of using the same to treat sleep disorders► Subscribe
9,498,462Doxepin trans isomers and isomeric mixtures and methods of using the same to treat sleep disorders► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: doxepin hydrochloride

Country Document Number Estimated Expiration
Japan2009537553► Subscribe
World Intellectual Property Organization (WIPO)2008011150► Subscribe
World Intellectual Property Organization (WIPO)2007136845► Subscribe
Japan2009537554► Subscribe
World Intellectual Property Organization (WIPO)2007142811► Subscribe
World Intellectual Property Organization (WIPO)2008128115► Subscribe
Canada2687124► Subscribe
World Intellectual Property Organization (WIPO)2007142810► Subscribe
Canada2687118► Subscribe
European Patent Office2026792► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
UBS
Cipla
Federal Trade Commission
Daiichi Sankyo
Deloitte
McKinsey
Moodys
Citi
Boehringer Ingelheim

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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