Milnacipran hydrochloride - Generic Drug Details

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What are the generic sources for milnacipran hydrochloride and what is the scope of patent protection?

Milnacipran hydrochloride is the generic ingredient in two branded drugs marketed by Amneal Pharms, Hetero Labs Ltd V, Oryza, and Abbvie, and is included in four NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Milnacipran hydrochloride has thirty-three patent family members in twenty-three countries.

There are twenty-six drug master file entries for milnacipran hydrochloride. Three suppliers are listed for this compound. There are five tentative approvals for this compound.

Summary for milnacipran hydrochloride

International Patents:	33
US Patents:	1
Tradenames:	2
Applicants:	4
NDAs:	4
Drug Master File Entries:	26
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	187
Clinical Trials:	56
Patent Applications:	654
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for milnacipran hydrochloride
What excipients (inactive ingredients) are in milnacipran hydrochloride?	milnacipran hydrochloride excipients list
DailyMed Link:	milnacipran hydrochloride at DailyMed

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

Generic filers with tentative approvals for MILNACIPRAN HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	100MG	TABLET;ORAL
⤷ Sign Up	⤷ Sign Up	50MG	TABLET;ORAL
⤷ Sign Up	⤷ Sign Up	25MG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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
Oryza	MILNACIPRAN HYDROCHLORIDE	milnacipran hydrochloride	TABLET;ORAL	205071-002	Jan 27, 2016		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Oryza	MILNACIPRAN HYDROCHLORIDE	milnacipran hydrochloride	TABLET;ORAL	205071-001	Jan 27, 2016		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hetero Labs Ltd V	MILNACIPRAN HYDROCHLORIDE	milnacipran hydrochloride	TABLET;ORAL	205147-002	Oct 3, 2024	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 milnacipran hydrochloride

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	SAVELLA	milnacipran hydrochloride	TABLET;ORAL	022256-004	Jan 14, 2009	⤷ Sign Up	⤷ Sign Up
Abbvie	SAVELLA	milnacipran hydrochloride	TABLET;ORAL	022256-001	Jan 14, 2009	⤷ Sign Up	⤷ Sign Up
Abbvie	SAVELLA	milnacipran hydrochloride	TABLET;ORAL	022256-002	Jan 14, 2009	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for milnacipran hydrochloride

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Country	Patent Number	Title	Estimated Expiration
European Patent Office	2682114	Milnacipran pour le traitement a long terme du syndrome de la fibromyalgie (Milnacipran for the long-term treatment of fibromyalgia syndrome)	⤷ Sign Up
Costa Rica	9882	MILNACIPRAN PARA EL TRATAMIENTO A LARGO PLAZO DEL SINDROME DE FIBROMIALGIA	⤷ Sign Up
European Patent Office	1928446	MILNACIPRAN POUR LE TRAITEMENT A LONG TERME DU SYNDROME DE LA FIBROMYALGIE (MILNACIPRAN FOR THE LONG-TERM TREATMENT OF FIBROMYALGIA SYNDROME)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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