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Last Updated: February 26, 2021

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SAVELLA Drug Profile

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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 four 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. Four suppliers are listed for this compound. Additional details are available on the milnacipran hydrochloride profile page.

US ANDA Litigation and Generic Entry Outlook for Savella

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

There have been eight 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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Drug patent expirations by year for SAVELLA
Drug Prices for SAVELLA

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Drug Sales Revenue Trends for SAVELLA

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Recent Clinical Trials for SAVELLA

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SponsorPhase
University of OttawaPhase 4
AllerganPhase 4
Spencer Dorn, MD, MPHPhase 2

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Paragraph IV (Patent) Challenges for SAVELLA
Tradename Dosage Ingredient NDA Submissiondate
SAVELLA TABLET;ORAL milnacipran hydrochloride 022256 2013-01-14

US Patents and Regulatory Information for 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   Start Trial   Start Trial   Start Trial
Allergan SAVELLA milnacipran hydrochloride TABLET;ORAL 022256-002 Jan 14, 2009 RX Yes No   Start Trial   Start Trial   Start Trial
Allergan SAVELLA milnacipran hydrochloride TABLET;ORAL 022256-001 Jan 14, 2009 RX Yes No   Start Trial   Start Trial   Start Trial
Allergan SAVELLA milnacipran hydrochloride TABLET;ORAL 022256-003 Jan 14, 2009 RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

McKesson
Johnson and Johnson
Dow
Mallinckrodt
Moodys
AstraZeneca

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