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Desvenlafaxine succinate - Generic Drug Details

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Desvenlafaxine succinate is the generic ingredient in two branded drugs marketed by Alembic Pharms Ltd, Sandoz Inc, Lupin Ltd, Roxane, Wyeth Pharms Inc, and Mylan Pharms Inc, and is included in seven 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 thirteen drug master file entries for desvenlafaxine succinate. Seven suppliers are listed for this compound.

Summary for Generic Name: desvenlafaxine succinate

Tradenames:2
Patents:2
Applicants:6
NDAs:7
Drug Master File Entries: see list13
Suppliers / Packaging: see list7
Formulation / Manufacturing:see details

Clinical Trials for: desvenlafaxine succinate

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Roxane
DESVENLAFAXINE SUCCINATE
desvenlafaxine succinate
TABLET, EXTENDED RELEASE;ORAL204082-001Feb 16, 2016RXNo<disabled><disabled>
Mylan Pharms Inc
DESVENLAFAXINE SUCCINATE
desvenlafaxine succinate
TABLET, EXTENDED RELEASE;ORAL204095-001Jun 29, 2015RXNo<disabled><disabled>
Lupin Ltd
DESVENLAFAXINE SUCCINATE
desvenlafaxine succinate
TABLET, EXTENDED RELEASE;ORAL204172-001Jun 29, 2015RXNo<disabled><disabled>
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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<disabled in preview>
7,026,508Succinate salt of O-desmethyl-venlafaxine<disabled in preview>
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International Patent Family for Ingredient: desvenlafaxine succinate

Country Document Number Estimated Expiration
Hungary0200898<disabled in preview>
Uruguay27175<disabled in preview>
Honduras2002000030<disabled in preview>
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