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Last Updated: July 28, 2021

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DESVENLAFAXINE SUCCINATE - Generic Drug Details

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What are the generic drug sources for desvenlafaxine succinate and what is the scope of freedom to operate?

Desvenlafaxine succinate is the generic ingredient in two branded drugs marketed by Actavis Labs Fl, Alembic Pharms Ltd, Hikma, Intellipharmaceutics, Lupin Ltd, Mylan, Rubicon, Yichang Humanwell, Zydus Pharms, and Pf Prism Cv, and is included in eleven NDAs. There are two patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Desvenlafaxine succinate has sixty-eight patent family members in thirty-two countries.

There are sixteen drug master file entries for desvenlafaxine succinate. Seventeen suppliers are listed for this compound.

Recent Clinical Trials for DESVENLAFAXINE SUCCINATE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Phase 3
Korea Cancer Center HospitalPhase 4
Seoul National University Bundang HospitalPhase 4

See all DESVENLAFAXINE SUCCINATE clinical trials

Medical Subject Heading (MeSH) Categories for DESVENLAFAXINE SUCCINATE
Paragraph IV (Patent) Challenges for DESVENLAFAXINE SUCCINATE
Tradename Dosage Ingredient NDA Submissiondate
PRISTIQ TABLET, EXTENDED RELEASE;ORAL desvenlafaxine succinate 021992 2015-05-08
PRISTIQ TABLET, EXTENDED RELEASE;ORAL desvenlafaxine succinate 021992 2012-02-29

US Patents and Regulatory Information for DESVENLAFAXINE SUCCINATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan DESVENLAFAXINE SUCCINATE desvenlafaxine succinate TABLET, EXTENDED RELEASE;ORAL 204095-001 Jun 29, 2015 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Mylan DESVENLAFAXINE SUCCINATE desvenlafaxine succinate TABLET, EXTENDED RELEASE;ORAL 204095-002 Jun 29, 2015 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Alembic Pharms Ltd DESVENLAFAXINE SUCCINATE desvenlafaxine succinate TABLET, EXTENDED RELEASE;ORAL 204003-003 Sep 14, 2018 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Express Scripts
Medtronic
Moodys
Dow
Mallinckrodt

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