SAVELLA Drug Patent Profile

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When do Savella patents expire, and what generic alternatives are available?

Savella is a drug marketed by Abbvie and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has thirty-three patent family members in twenty-three countries.

The generic ingredient in SAVELLA 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 Savella

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

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Summary for SAVELLA

International Patents:	33
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	74
Clinical Trials:	27
Patent Applications:	405
Drug Prices:	Drug price information for SAVELLA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SAVELLA
What excipients (inactive ingredients) are in SAVELLA?	SAVELLA excipients list
DailyMed Link:	SAVELLA at DailyMed

Drug patent expirations by year for SAVELLA

Recent Clinical Trials for SAVELLA

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

Sponsor	Phase
University of Ottawa	Phase 4
Allergan	Phase 4
Research Foundation for Mental Hygiene, Inc.	N/A

See all SAVELLA clinical trials

Pharmacology for SAVELLA

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

Paragraph IV (Patent) Challenges for SAVELLA

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 SAVELLA

SAVELLA is protected by one US patents.

Patents protecting SAVELLA

Milnacipran for the long-term treatment of fibromyalgia syndrome
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: MANAGEMENT OF FIBROMYALGIA

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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
Abbvie	SAVELLA	milnacipran hydrochloride	TABLET;ORAL	022256-001	Jan 14, 2009	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Abbvie	SAVELLA	milnacipran hydrochloride	TABLET;ORAL	022256-004	Jan 14, 2009	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Abbvie	SAVELLA	milnacipran hydrochloride	TABLET;ORAL	022256-002	Jan 14, 2009	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Abbvie	SAVELLA	milnacipran hydrochloride	TABLET;ORAL	022256-003	Jan 14, 2009	AB	RX	Yes	Yes	⤷ 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 SAVELLA

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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
Abbvie	SAVELLA	milnacipran hydrochloride	TABLET;ORAL	022256-002	Jan 14, 2009	⤷ Sign Up	⤷ Sign Up
Abbvie	SAVELLA	milnacipran hydrochloride	TABLET;ORAL	022256-003	Jan 14, 2009	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for SAVELLA

See the table below for patents covering SAVELLA around the world.

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Country	Patent Number	Title	Estimated Expiration
Russian Federation	2437661	МИЛНАЦИПРАН В КАЧЕСТВЕ СРЕДСТВА ДЛЯ ПРОДОЛЖИТЕЛЬНОГО ЛЕЧЕНИЯ СИНДРОМА ФИБРОМИАЛГИИ (MILNACIPRAN AS MEDICATION FOR CONTINUOUS TREATMENT OF FIBROMYALGIA SYNDROME)	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2004009069		⤷ Sign Up
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
World Intellectual Property Organization (WIPO)	2007038620		⤷ Sign Up
Japan	6014702		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration