MILNACIPRAN HYDROCHLORIDE Drug Patent Profile

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Which patents cover Milnacipran Hydrochloride, and when can generic versions of Milnacipran Hydrochloride launch?

Milnacipran Hydrochloride is a drug marketed by Amneal Pharms, Hetero Labs Ltd V, and Oryza. and is included in three NDAs.

The generic ingredient in MILNACIPRAN HYDROCHLORIDE is milnacipran hydrochloride. There are twenty-eight drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the milnacipran hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Milnacipran Hydrochloride

A generic version of MILNACIPRAN HYDROCHLORIDE was approved as milnacipran hydrochloride by HETERO LABS LTD V on October 3^rd, 2024.

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Summary for MILNACIPRAN HYDROCHLORIDE

US Patents:	0
Applicants:	3
NDAs:	3
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	187
Clinical Trials:	56
Patent Applications:	414
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for MILNACIPRAN HYDROCHLORIDE
DailyMed Link:	MILNACIPRAN HYDROCHLORIDE at DailyMed

Drug patent expirations by year for MILNACIPRAN HYDROCHLORIDE

Recent Clinical Trials for MILNACIPRAN HYDROCHLORIDE

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

Sponsor	Phase
Mansoura University	N/A
Yousra Hisham Abdel Fattah	N/A
University of Ottawa	Phase 4

See all MILNACIPRAN HYDROCHLORIDE clinical trials

Pharmacology for MILNACIPRAN HYDROCHLORIDE

Drug Class	Serotonin and Norepinephrine Reuptake Inhibitor
Mechanism of Action	Norepinephrine Uptake Inhibitors Serotonin Uptake Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for MILNACIPRAN HYDROCHLORIDE

N06AX	Other antidepressants
N06A	ANTIDEPRESSANTS
N06	PSYCHOANALEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for MILNACIPRAN HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SAVELLA	Tablets	milnacipran hydrochloride	12.5 mg, 25 mg, 50 mg, and 100 mg	022256	8	2013-01-14

US Patents and Regulatory Information for MILNACIPRAN HYDROCHLORIDE

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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
Amneal Pharms	MILNACIPRAN HYDROCHLORIDE	milnacipran hydrochloride	TABLET;ORAL	205081-001	Apr 22, 2016		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hetero Labs Ltd V	MILNACIPRAN HYDROCHLORIDE	milnacipran hydrochloride	TABLET;ORAL	205147-003	Oct 3, 2024	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Amneal Pharms	MILNACIPRAN HYDROCHLORIDE	milnacipran hydrochloride	TABLET;ORAL	205081-004	Apr 22, 2016		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Oryza	MILNACIPRAN HYDROCHLORIDE	milnacipran hydrochloride	TABLET;ORAL	205071-004	Jan 27, 2016		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hetero Labs Ltd V	MILNACIPRAN HYDROCHLORIDE	milnacipran hydrochloride	TABLET;ORAL	205147-004	Oct 3, 2024	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Amneal Pharms	MILNACIPRAN HYDROCHLORIDE	milnacipran hydrochloride	TABLET;ORAL	205081-002	Apr 22, 2016		DISCN	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