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Last Updated: March 28, 2024

Milnacipran hydrochloride - Generic Drug Details


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What are the generic drug 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 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.

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
Uspharma Windlas MILNACIPRAN HYDROCHLORIDE milnacipran hydrochloride TABLET;ORAL 205071-002 Jan 27, 2016 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Amneal Pharms MILNACIPRAN HYDROCHLORIDE milnacipran hydrochloride TABLET;ORAL 205081-003 Apr 22, 2016 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Amneal Pharms MILNACIPRAN HYDROCHLORIDE milnacipran hydrochloride TABLET;ORAL 205081-002 Apr 22, 2016 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Uspharma Windlas MILNACIPRAN HYDROCHLORIDE milnacipran hydrochloride TABLET;ORAL 205071-001 Jan 27, 2016 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Uspharma Windlas MILNACIPRAN HYDROCHLORIDE milnacipran hydrochloride TABLET;ORAL 205071-004 Jan 27, 2016 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Uspharma Windlas MILNACIPRAN HYDROCHLORIDE milnacipran hydrochloride TABLET;ORAL 205071-003 Jan 27, 2016 DISCN No 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 022256-004 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 022256-002 Jan 14, 2009 ⤷  Try a Trial ⤷  Try a Trial
Abbvie SAVELLA milnacipran hydrochloride TABLET;ORAL 022256-003 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
Singapore 10201807899P MILNACIPRAN FOR THE LONG-TERM TREATMENT OF FIBROMYALGIA SYNDROME ⤷  Try a Trial
New Zealand 593199 Milnacipran for the long-term treatment of fybromyalgia syndrome ⤷  Try a Trial
Russian Federation 2437661 МИЛНАЦИПРАН В КАЧЕСТВЕ СРЕДСТВА ДЛЯ ПРОДОЛЖИТЕЛЬНОГО ЛЕЧЕНИЯ СИНДРОМА ФИБРОМИАЛГИИ (MILNACIPRAN AS MEDICATION FOR CONTINUOUS TREATMENT OF FIBROMYALGIA SYNDROME) ⤷  Try a Trial
South Korea 20080055967 MILNACIPRAN FOR THE LONG-TERM TREATMENT OF FIBROMYALGIA SYNDROME ⤷  Try a Trial
Nicaragua 200800099 MILNACIPAN PARA EL TRATAMIENTO A LARGO PLAZO DEL SÍNDROME DE FIBROMALGIA ⤷  Try a Trial
Costa Rica 9882 MILNACIPRAN PARA EL TRATAMIENTO A LARGO PLAZO DEL SINDROME DE FIBROMIALGIA ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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