Unlock all Features See Plans and Pricing

Serving leading biopharmaceutical companies globally:

Express Scripts
Baxter
Moodys
McKesson
Boehringer Ingelheim
Johnson and Johnson

Last Updated: December 8, 2022

Levomilnacipran hydrochloride - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard

▶ Start for $1
Remove trial restrictions


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

Levomilnacipran hydrochloride is the generic ingredient in two branded drugs marketed by Allergan, Amneal Pharms Co, and Hikma, and is included in three NDAs. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Levomilnacipran hydrochloride has fifty-four patent family members in twenty-seven countries.

There are ten drug master file entries for levomilnacipran hydrochloride. Two suppliers are listed for this compound.

Summary for levomilnacipran hydrochloride
Recent Clinical Trials for levomilnacipran hydrochloride

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

SponsorPhase
AllerganPhase 3
University of OttawaPhase 4
AllerganPhase 4

See all levomilnacipran hydrochloride clinical trials

Pharmacology for levomilnacipran hydrochloride
Paragraph IV (Patent) Challenges for LEVOMILNACIPRAN HYDROCHLORIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
FETZIMA Extended-release Capsules levomilnacipran hydrochloride 20 mg, 40 mg, 80 mg and 120 mg 204168 6 2017-07-25

US Patents and Regulatory Information for levomilnacipran hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Allergan FETZIMA levomilnacipran hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 204168-002 Jul 25, 2013 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Allergan FETZIMA levomilnacipran hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 204168-001 Jul 25, 2013 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Allergan FETZIMA levomilnacipran hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 204168-004 Jul 25, 2013 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y 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

International Patents for levomilnacipran hydrochloride

Country Patent Number Title Estimated Expiration
Denmark 1601349 See Plans and Pricing
Morocco 27655 UTILISATION DE L'ENANTIOMERE (1S,2R) DU MILNACIPRAN POUR LA PREPARATION D'UN MEDICAMENT See Plans and Pricing
European Patent Office 2536688 FORMES POSOLOGIQUES STABLES DE LEVOMILNACIPRAN (STABLE DOSAGE FORMS OF LEVOMILNACIPRAN) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Merck
McKinsey
AstraZeneca
McKesson
Dow
Boehringer Ingelheim

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.