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Last Updated: December 1, 2022

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 Allergan, 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
AllerganPhase 4

See all milnacipran hydrochloride clinical trials

Generic filers with tentative approvals for MILNACIPRAN HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing12.5MGTABLET;ORAL
See Plans and PricingSee Plans and Pricing100MGTABLET;ORAL
See Plans and PricingSee Plans and Pricing50MGTABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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
Allergan SAVELLA milnacipran hydrochloride TABLET;ORAL 022256-004 Jan 14, 2009 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Allergan SAVELLA milnacipran hydrochloride TABLET;ORAL 022256-003 Jan 14, 2009 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Allergan SAVELLA milnacipran hydrochloride TABLET;ORAL 022256-002 Jan 14, 2009 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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
Allergan SAVELLA milnacipran hydrochloride TABLET;ORAL 022256-003 Jan 14, 2009 See Plans and Pricing See Plans and Pricing
Allergan SAVELLA milnacipran hydrochloride TABLET;ORAL 022256-004 Jan 14, 2009 See Plans and Pricing See Plans and Pricing
Allergan SAVELLA milnacipran hydrochloride TABLET;ORAL 022256-001 Jan 14, 2009 See Plans and Pricing See Plans and Pricing
>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) See Plans and Pricing
Portugal 1463528 See Plans and Pricing
Spain 2433080 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.