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Doxepin hydrochloride - Generic Drug Details

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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, Delcor Asset Corp, Quantum Pharmics, Pernix Theraps Llc, Mylan Pharms Inc, Actavis Elizabeth, Dava Pharms Inc, and New River, and is included in fifty-nine NDAs. There are four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

This ingredient has twelve patent family members in four countries.

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

Summary for Generic Name: doxepin hydrochloride

Tradenames:4
Patents:4
Applicants:17
NDAs:59
Drug Master File Entries: see list7
Suppliers / Packaging: see list27
Therapeutic Class:Antidepressants
Anxiolytics
Dermatological Agents
Formulation / Manufacturing:see details

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
Dava Pharms Inc
DOXEPIN HYDROCHLORIDE
doxepin hydrochloride
CAPSULE;ORAL071673-001Jan 5, 1988DISCNNo<disabled><disabled>
Sandoz
DOXEPIN HYDROCHLORIDE
doxepin hydrochloride
CAPSULE;ORAL070827-001May 15, 1986DISCNNo<disabled><disabled>
Dava Pharms Inc
DOXEPIN HYDROCHLORIDE
doxepin hydrochloride
CAPSULE;ORAL071686-001Jan 5, 1988DISCNNo<disabled><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, 20105,585,115<disabled>
Pfizer
SINEQUAN
doxepin hydrochloride
CAPSULE;ORAL016798-006Approved Prior to Jan 1, 19823,420,851<disabled>
New River
DOXEPIN HYDROCHLORIDE
doxepin hydrochloride
CAPSULE;ORAL016987-001Approved Prior to Jan 1, 19823,420,851<disabled>
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International Patent Family for Ingredient: doxepin hydrochloride

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO)2008011150<disabled in preview>
Japan2009537554<disabled in preview>
Canada2687124<disabled in preview>
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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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