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Details for Generic Name: doxepin hydrochloride

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

This ingredient has fifty-three patent family members in seventeen countries.

There are seven drug master file entries for doxepin hydrochloride. Six suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for Generic Name: doxepin hydrochloride

Tradenames:4
Patents:10
Applicants:17
NDAs:58
Drug Master File Entries: see list7
Suppliers / Packaging: see list17
Therapeutic Class:Antidepressants
Anxiolytics
Dermatological Agents

Pharmacology for Ingredient: doxepin hydrochloride

Tentative approvals for DOXEPIN HYDROCHLORIDE

Applicant Application No. Form Dosage
<disabled><disabled>TABLET; ORAL3MG
<disabled><disabled>TABLET; ORAL6MG
<disabled><disabled>TABLET; ORAL3MG

Clinical Trials for: doxepin hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan Pharms Inc
DOXEPIN HYDROCHLORIDE
doxepin hydrochloride
CAPSULE;ORAL070791-001May 13, 1986RXNo<disabled><disabled>
New River
DOXEPIN HYDROCHLORIDE
doxepin hydrochloride
CAPSULE;ORAL016987-006Approved Prior to Jan 1, 1982DISCNNo<disabled><disabled>
Pernix Theraps Llc
SILENOR
doxepin hydrochloride
TABLET;ORAL022036-001Mar 17, 2010RXNo5,585,115<disabled>Y <disabled>
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Expired Orange Book Patents for Generic Ingredient: doxepin hydrochloride

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pernix Theraps Llc
SILENOR
doxepin hydrochloride
TABLET;ORAL022036-002Mar 17, 20105,502,047<disabled>
Pernix Theraps Llc
SILENOR
doxepin hydrochloride
TABLET;ORAL022036-001Mar 17, 20105,866,166<disabled>
Pernix Theraps Llc
SILENOR
doxepin hydrochloride
TABLET;ORAL022036-002Mar 17, 20106,103,219<disabled>
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International Patent Family for Ingredient: doxepin hydrochloride

Country Document Number Publication Date
JapanH10500426Jan 13, 1998
Germany69638054Nov 26, 2009
Finland963497Nov 06, 1996
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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 information. There is no warranty that the information contained herein is error free. 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.

Copyright 2002-2016 thinkBiotech LLC
ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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