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Last Updated: November 2, 2024

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 Abbvie, and is included in three NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Milnacipran hydrochloride has thirty-three patent family members in twenty-three 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.

Summary for milnacipran hydrochloride
Recent Clinical Trials for milnacipran hydrochloride

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

SponsorPhase
Mansoura UniversityN/A
Yousra Hisham Abdel FattahN/A
AllerganPhase 4

See all milnacipran hydrochloride clinical trials

Generic filers with tentative approvals for MILNACIPRAN HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign Up100MGTABLET;ORAL
⤷  Sign Up⤷  Sign Up50MGTABLET;ORAL
⤷  Sign Up⤷  Sign Up25MGTABLET;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
Anatomical Therapeutic Chemical (ATC) Classes 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
Abbvie SAVELLA milnacipran hydrochloride TABLET;ORAL 022256-001 Jan 14, 2009 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Abbvie SAVELLA milnacipran hydrochloride TABLET;ORAL 022256-003 Jan 14, 2009 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Uspharma Windlas MILNACIPRAN HYDROCHLORIDE milnacipran hydrochloride TABLET;ORAL 205071-004 Jan 27, 2016 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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 022256-002 Jan 14, 2009 ⤷  Sign Up ⤷  Sign Up
Abbvie SAVELLA milnacipran hydrochloride TABLET;ORAL 022256-004 Jan 14, 2009 ⤷  Sign Up ⤷  Sign Up
Abbvie SAVELLA milnacipran hydrochloride TABLET;ORAL 022256-001 Jan 14, 2009 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for milnacipran hydrochloride

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) ⤷  Sign Up
Japan 2012193216 MILNACIPRAN FOR LONG-TERM TREATMENT OF FIBROMYALGIA SYNDROME ⤷  Sign Up
Tunisia SN08129 MILNACIPRAN FOR THE LONG-TERM TREATMENT OF FIBROMYALGIA SYNDROME ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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