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Desvenlafaxine succinate - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for desvenlafaxine succinate?

Desvenlafaxine succinate is the generic ingredient in two branded drugs marketed by Alembic Pharms Ltd, Sandoz Inc, Actavis Labs Fl Inc, Lupin Ltd, West-ward Pharms Int, Wyeth Pharms Inc, and Mylan Pharms Inc, and is included in eight NDAs. There are two patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has sixty-two patent family members in thirty-two countries.

There are fifteen drug master file entries for desvenlafaxine succinate. Thirteen suppliers are listed for this compound.

Summary for Generic Name: desvenlafaxine succinate

Tradenames:2
Patents:3
Applicants:7
NDAs:8
Drug Master File Entries: see list15
Suppliers / Packagers: see list13
Clinical Trials: see list62
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:desvenlafaxine succinate at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Actavis Labs Fl Inc
DESVENLAFAXINE SUCCINATE
desvenlafaxine succinate
TABLET, EXTENDED RELEASE;ORAL204065-003Jul 29, 2016RXNoNo► Subscribe► Subscribe
Alembic Pharms Ltd
DESVENLAFAXINE SUCCINATE
desvenlafaxine succinate
TABLET, EXTENDED RELEASE;ORAL204003-002Jun 29, 2015RXNoNo► Subscribe► Subscribe
West-ward Pharms Int
DESVENLAFAXINE SUCCINATE
desvenlafaxine succinate
TABLET, EXTENDED RELEASE;ORAL204082-001Feb 16, 2016RXNoNo► Subscribe► Subscribe
Mylan Pharms Inc
DESVENLAFAXINE SUCCINATE
desvenlafaxine succinate
TABLET, EXTENDED RELEASE;ORAL204095-002Jun 29, 2015RXNoNo► Subscribe► Subscribe
Wyeth Pharms Inc
PRISTIQ
desvenlafaxine succinate
TABLET, EXTENDED RELEASE;ORAL021992-002Feb 29, 2008RXYesYes6,673,838► SubscribeY ► Subscribe
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Non-Orange Book Patents for Generic Ingredient: desvenlafaxine succinate

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
7,291,347Succinate salt of O-desmethyl-venlafaxine► Subscribe
7,026,508Succinate salt of O-desmethyl-venlafaxine► 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: desvenlafaxine succinate

Country Document Number Estimated Expiration
Norway20033538► Subscribe
Denmark1466889► Subscribe
Australia4062700► Subscribe
European Patent Office1905757► Subscribe
European Patent Office1466889► 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.

Export unavailable in trial.
Subscribe for complete access.

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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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