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Last Updated: August 5, 2020

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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, Uspharma Windlas, and Allergan, and is included in three NDAs. There are four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Milnacipran hydrochloride has forty-nine patent family members in twenty-seven countries.

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

Recent Clinical Trials for milnacipran hydrochloride

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

SponsorPhase
Yousra Hisham Abdel FattahN/A
AllerganPhase 4
University of OttawaPhase 4

See all milnacipran hydrochloride clinical trials

Generic filers with tentative approvals for MILNACIPRAN HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial25MGTABLET;ORAL
  Start Trial  Start Trial12.5MGTABLET;ORAL
  Start Trial  Start Trial100MGTABLET;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
Paragraph IV (Patent) Challenges for MILNACIPRAN HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
SAVELLA TABLET;ORAL milnacipran hydrochloride 022256 2013-01-14

US Patents and Regulatory Information for milnacipran hydrochloride

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 022256-003 Jan 14, 2009 RX Yes Yes   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
Allergan SAVELLA milnacipran hydrochloride TABLET;ORAL 022256-004 Jan 14, 2009 RX Yes No   Start Trial   Start Trial   Start Trial
Amneal Pharms MILNACIPRAN HYDROCHLORIDE milnacipran hydrochloride TABLET;ORAL 205081-002 Apr 22, 2016 DISCN No No   Start Trial   Start Trial   Start Trial
Allergan SAVELLA milnacipran hydrochloride TABLET;ORAL 022256-004 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 022256-004 Jan 14, 2009 RX Yes No   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:

Medtronic
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Express Scripts

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