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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
Drug Prices:see low prices

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
Pernix Theraps Llc
SILENOR
doxepin hydrochloride
TABLET;ORAL022036-002Mar 17, 2010RXYes8,513,299Sep 7, 2030
Pfizer
SINEQUAN
doxepin hydrochloride
CAPSULE;ORAL016798-001Approved Prior to Jan 1, 1982DISCNNo
Pharm Assoc
DOXEPIN HYDROCHLORIDE
doxepin hydrochloride
CONCENTRATE;ORAL075924-001Jan 15, 2004DISCNNo
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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
Pfizer
SINEQUAN
doxepin hydrochloride
CAPSULE;ORAL016798-006Approved Prior to Jan 1, 19823,420,851<disabled>
Pfizer
SINEQUAN
doxepin hydrochloride
CAPSULE;ORAL016798-005Approved Prior to Jan 1, 19823,420,851<disabled>
Pernix Theraps Llc
SILENOR
doxepin hydrochloride
TABLET;ORAL022036-002Mar 17, 20105,866,166<disabled>
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International Patent Family for Ingredient: doxepin hydrochloride

Country Document Number Estimated Expiration
Japan2013237694<disabled in preview>
Japan2016041757<disabled in preview>
Canada2693992<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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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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