SAVELLA Drug Patent Profile

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

Savella is a drug marketed by Allergan and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has forty-nine patent family members in twenty-seven 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^® Generic Entry Outlook for Savella

Savella was eligible for patent challenges on January 14, 2013.

There have been thirteen patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There are five tentative approvals for the generic drug (milnacipran hydrochloride), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for SAVELLA

International Patents:	49
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	71
Clinical Trials:	27
Patent Applications:	367
Formulation / Manufacturing:	see details
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

See drug prices for SAVELLA

See drug sales revenues for SAVELLA

Recent Clinical Trials for SAVELLA

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

Sponsor	Phase
Allergan	Phase 4
University of Ottawa	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

Anatomical Therapeutic Chemical (ATC) Classes for SAVELLA

N06AX	Other antidepressants
N06A	ANTIDEPRESSANTS
N06	PSYCHOANALEPTICS
N	Nervous system

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 two US patents.

Patents protecting SAVELLA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Allergan	SAVELLA	milnacipran hydrochloride	TABLET;ORAL	022256-001	Jan 14, 2009		RX	Yes	No
Allergan	SAVELLA	milnacipran hydrochloride	TABLET;ORAL	022256-004	Jan 14, 2009		RX	Yes	No
Allergan	SAVELLA	milnacipran hydrochloride	TABLET;ORAL	022256-002	Jan 14, 2009		RX	Yes	No

Expired US Patents for SAVELLA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Allergan	SAVELLA	milnacipran hydrochloride	TABLET;ORAL	022256-002	Jan 14, 2009
Allergan	SAVELLA	milnacipran hydrochloride	TABLET;ORAL	022256-002	Jan 14, 2009
Allergan	SAVELLA	milnacipran hydrochloride	TABLET;ORAL	022256-001	Jan 14, 2009

International Patents for SAVELLA

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

Country	Patent Number	Title	Estimated Expiration
Singapore	10201706677T	MILNACIPRAN FOR THE LONG-TERM TREATMENT OF FIBROMYALGIA SYNDROME
El Salvador	2008002855	MILNACIPRAN PARA EL TRATAMIENTO A LARGO PLAZO DEL SINDROME DE FIBROMIALGIA
Russian Federation	2437661	МИЛНАЦИПРАН В КАЧЕСТВЕ СРЕДСТВА ДЛЯ ПРОДОЛЖИТЕЛЬНОГО ЛЕЧЕНИЯ СИНДРОМА ФИБРОМИАЛГИИ (MILNACIPRAN AS MEDICATION FOR CONTINUOUS TREATMENT OF FIBROMYALGIA SYNDROME)