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Last Updated: February 22, 2024

Milnacipran hydrochloride - Generic Drug Details


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What are the generic sources for milnacipran hydrochloride and what is the scope of freedom to operate?

Milnacipran hydrochloride is the generic ingredient in two branded drugs marketed by Amneal Pharms, Uspharma Windlas, and Abbvie, and is included in three NDAs. There are two 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-six drug master file entries for milnacipran hydrochloride. Three 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
Mansoura UniversityN/A
Yousra Hisham Abdel FattahN/A
University of OttawaPhase 4

See all milnacipran hydrochloride clinical trials

Generic filers with tentative approvals for MILNACIPRAN HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial100MGTABLET;ORAL
⤷  Try a Trial⤷  Try a Trial50MGTABLET;ORAL
⤷  Try a Trial⤷  Try a Trial25MGTABLET;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 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 milnacipran hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Amneal Pharms MILNACIPRAN HYDROCHLORIDE milnacipran hydrochloride TABLET;ORAL 205081-004 Apr 22, 2016 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Amneal Pharms MILNACIPRAN HYDROCHLORIDE milnacipran hydrochloride TABLET;ORAL 205081-001 Apr 22, 2016 DISCN No 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 022256-004 Jan 14, 2009 RX Yes No ⤷  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 milnacipran hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Abbvie SAVELLA milnacipran hydrochloride TABLET;ORAL 022256-003 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 022256-002 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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for milnacipran hydrochloride

Country Patent Number Title Estimated Expiration
Morocco 31720 MILNACIPRAN POUR LE TRAITEMENT A LONG TERME DU SYNDROME DE LA FIBROMYALGIE ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2007038620 ⤷  Try a Trial
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
China 101355930 Milnacipran for the long- term treatment of fibromyalgia syndrome ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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