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^® Generic Entry Outlook for Savella

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

There have been four 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

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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:	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

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
Alla Landa	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 one US patents.

Patents protecting SAVELLA

Milnacipran for the long-term treatment of fibromyalgia syndrome
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Abbvie	SAVELLA	milnacipran hydrochloride	TABLET;ORAL	022256-004	Jan 14, 2009		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Abbvie	SAVELLA	milnacipran hydrochloride	TABLET;ORAL	022256-002	Jan 14, 2009		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Abbvie	SAVELLA	milnacipran hydrochloride	TABLET;ORAL	022256-003	Jan 14, 2009		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>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	022256-001	Jan 14, 2009	⤷ Try a Trial	⤷ Try a Trial
Abbvie	SAVELLA	milnacipran hydrochloride	TABLET;ORAL	022256-002	Jan 14, 2009	⤷ Try a Trial	⤷ Try a Trial
Abbvie	SAVELLA	milnacipran hydrochloride	TABLET;ORAL	022256-002	Jan 14, 2009	⤷ Try a Trial	⤷ Try a Trial
Abbvie	SAVELLA	milnacipran hydrochloride	TABLET;ORAL	022256-001	Jan 14, 2009	⤷ Try a Trial	⤷ Try a Trial
Abbvie	SAVELLA	milnacipran hydrochloride	TABLET;ORAL	022256-004	Jan 14, 2009	⤷ Try a Trial	⤷ Try a Trial
Abbvie	SAVELLA	milnacipran hydrochloride	TABLET;ORAL	022256-004	Jan 14, 2009	⤷ Try a Trial	⤷ Try a Trial
Abbvie	SAVELLA	milnacipran hydrochloride	TABLET;ORAL	022256-002	Jan 14, 2009	⤷ Try a Trial	⤷ Try a Trial
>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
Israel	228904	שימוש במילנקיפרן, או מלח מתאים פרמצבטי, בהכנת תרופה לטיפול בפיברומילג'יה (Use of milnacipran or a pharmaceutically acceptable salt thereof in the preparation of a medicament for treating fibromyalgia)	⤷ Try a Trial
Mexico	PA05000566	TRATAMIENTO DE DEPRESION SECUNDARIA AL DOLOR (DSP). (TREATMENT OF DEPRESSION SECONDARY TO PAIN (DSP).)	⤷ Try a Trial
Singapore	10201807899P	MILNACIPRAN FOR THE LONG-TERM TREATMENT OF FIBROMYALGIA SYNDROME	⤷ Try a Trial
New Zealand	567271	Milnacipran for the long-term treatment of fibromyalgia syndrome	⤷ Try a Trial
Portugal	2322225		⤷ Try a Trial
European Patent Office	2322225	Inhibiteurs sélectifs de récaptage de la norépinéphrine et de la sérotonine utilisés dans le traitement du syndrome de la fibromyosite, de l'encéphalo-myélite myalgique et de la douleur (Selective norepinephrine serotonin reuptake inhibitors for treating fibromyalgia syndrome, chronic fatigue syndrome and pain)	⤷ Try a Trial
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)	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration