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, Hikma, Intellipharmaceutics, Lupin Ltd, Norvium Bioscience, Rubicon, Yichang Humanwell, Zydus Pharms, and Pf Prism Cv, and is included in eleven NDAs. There is one patent protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Desvenlafaxine succinate has twenty-two patent family members in sixteen countries.

There are eleven drug master file entries for desvenlafaxine succinate. Twenty-two suppliers are listed for this compound.

Summary for DESVENLAFAXINE SUCCINATE

International Patents:	22
US Patents:	1
Tradenames:	2
Applicants:	10
NDAs:	11
Drug Master File Entries:	11
Finished Product Suppliers / Packagers:	22
Raw Ingredient (Bulk) Api Vendors:	44
Clinical Trials:	40
Patent Applications:	537
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DESVENLAFAXINE SUCCINATE
What excipients (inactive ingredients) are in DESVENLAFAXINE SUCCINATE?	DESVENLAFAXINE SUCCINATE excipients list
DailyMed Link:	DESVENLAFAXINE SUCCINATE at DailyMed

Recent Clinical Trials for DESVENLAFAXINE SUCCINATE

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

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

See all DESVENLAFAXINE SUCCINATE clinical trials

Pharmacology for DESVENLAFAXINE SUCCINATE

Drug Class	Serotonin and Norepinephrine Reuptake Inhibitor
Mechanism of Action	Cytochrome P450 2D6 Inhibitors Norepinephrine Uptake Inhibitors Serotonin Uptake Inhibitors

Medical Subject Heading (MeSH) Categories for DESVENLAFAXINE SUCCINATE

Antidepressive Agents
Serotonin and Noradrenaline Reuptake Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for DESVENLAFAXINE SUCCINATE

N06AX	Other antidepressants
N06A	ANTIDEPRESSANTS
N06	PSYCHOANALEPTICS
N	Nervous system

N06AX	Other antidepressants
N06A	ANTIDEPRESSANTS
N06	PSYCHOANALEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for DESVENLAFAXINE SUCCINATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
PRISTIQ	Extended-release Tablets	desvenlafaxine succinate	25 mg	021992	1	2015-05-08
PRISTIQ	Extended-release Tablets	desvenlafaxine succinate	50 mg and 100 mg	021992	12	2012-02-29

US Patents and Regulatory Information for DESVENLAFAXINE SUCCINATE

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Zydus Pharms	DESVENLAFAXINE SUCCINATE	desvenlafaxine succinate	TABLET, EXTENDED RELEASE;ORAL	204020-001	Oct 11, 2017	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Lupin Ltd	DESVENLAFAXINE SUCCINATE	desvenlafaxine succinate	TABLET, EXTENDED RELEASE;ORAL	204172-001	Jun 29, 2015	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Lupin Ltd	DESVENLAFAXINE SUCCINATE	desvenlafaxine succinate	TABLET, EXTENDED RELEASE;ORAL	204172-002	Jun 29, 2015	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hikma	DESVENLAFAXINE SUCCINATE	desvenlafaxine succinate	TABLET, EXTENDED RELEASE;ORAL	204082-002	Aug 28, 2017	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Rubicon	DESVENLAFAXINE SUCCINATE	desvenlafaxine succinate	TABLET, EXTENDED RELEASE;ORAL	204028-003	Dec 7, 2023	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Actavis Labs Fl	DESVENLAFAXINE SUCCINATE	desvenlafaxine succinate	TABLET, EXTENDED RELEASE;ORAL	204065-001	Jul 29, 2016	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for DESVENLAFAXINE SUCCINATE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pf Prism Cv	PRISTIQ	desvenlafaxine succinate	TABLET, EXTENDED RELEASE;ORAL	021992-002	Feb 29, 2008	⤷ Sign Up	⤷ Sign Up
Pf Prism Cv	PRISTIQ	desvenlafaxine succinate	TABLET, EXTENDED RELEASE;ORAL	021992-003	Aug 20, 2014	⤷ Sign Up	⤷ Sign Up
Pf Prism Cv	PRISTIQ	desvenlafaxine succinate	TABLET, EXTENDED RELEASE;ORAL	021992-002	Feb 29, 2008	⤷ Sign Up	⤷ Sign Up
Pf Prism Cv	PRISTIQ	desvenlafaxine succinate	TABLET, EXTENDED RELEASE;ORAL	021992-001	Feb 29, 2008	⤷ Sign Up	⤷ Sign Up
Pf Prism Cv	PRISTIQ	desvenlafaxine succinate	TABLET, EXTENDED RELEASE;ORAL	021992-001	Feb 29, 2008	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for DESVENLAFAXINE SUCCINATE

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Country	Patent Number	Title	Estimated Expiration
Poland	350924		⤷ Sign Up
European Patent Office	1905757		⤷ Sign Up
Cyprus	1108202		⤷ Sign Up
Hungary	0200898		⤷ Sign Up
Austria	397581		⤷ Sign Up
European Patent Office	2133325		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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