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FETZIMA Drug Patent Profile
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Which patents cover Fetzima, and when can generic versions of Fetzima launch?
Fetzima is a drug marketed by Allergan and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.
This drug has fifty-four patent family members in twenty-seven countries.
The generic ingredient in FETZIMA is levomilnacipran hydrochloride. There are eleven drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the levomilnacipran hydrochloride profile page.
DrugPatentWatch® Generic Entry Outlook for Fetzima
There have been nine patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
Summary for FETZIMA
| International Patents: | 54 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 79 |
| Clinical Trials: | 7 |
| Patent Applications: | 386 |
| Drug Prices: | Drug price information for FETZIMA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for FETZIMA |
| What excipients (inactive ingredients) are in FETZIMA? | FETZIMA excipients list |
| DailyMed Link: | FETZIMA at DailyMed |
Recent Clinical Trials for FETZIMA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Ottawa | Phase 4 |
| Allergan | Phase 4 |
| National Institute of Mental Health (NIMH) | Phase 4 |
Pharmacology for FETZIMA
| Drug Class | Serotonin and Norepinephrine Reuptake Inhibitor |
| Mechanism of Action | Norepinephrine Uptake Inhibitors Serotonin Uptake Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for FETZIMA
Paragraph IV (Patent) Challenges for FETZIMA
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| FETZIMA | CAPSULE, EXTENDED RELEASE;ORAL | levomilnacipran hydrochloride | 204168 | 2017-07-25 |
US Patents and Regulatory Information for FETZIMA
FETZIMA is protected by three US patents and one FDA Regulatory Exclusivity.
Patents protecting FETZIMA
Stable dosage forms of levomilnacipran
Patent Number: ⤷ Sign up for a Free Trial
Patent Expiration: ⤷ Sign up for a Free Trial
Patented Use: TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD)
Crystalline forms of (1S,2R)-2-(amino methyl)-N,N-diethyl-1-phenyl cyclopropane carboxamide
Patent Number: ⤷ Sign up for a Free Trial
Patent Expiration: ⤷ Sign up for a Free Trial
Use of the dextrogyral enantiomer of milnacipran for the preparation of a drug
Patent Number: ⤷ Sign up for a Free Trial
Patent Expiration: ⤷ Sign up for a Free Trial
Patented Use: TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD)
FDA Regulatory Exclusivity protecting FETZIMA
INFORMATION ADDED TO THE LABELING TO DESCRIBE STUDY LVM-MD-15 TO FULFILL POSTMARKETING COMMITMENT 1943-4
Exclusivity Expiration: ⤷ Sign up for a Free Trial
International Patents for FETZIMA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Ukraine | 84697 | ⤷ Sign up for a Free Trial |
| Hong Kong | 1115329 | ⤷ Sign up for a Free Trial |
| World Intellectual Property Organization (WIPO) | 2004075886 | ⤷ Sign up for a Free Trial |
| Germany | 602004031893 | ⤷ Sign up for a Free Trial |
| Spain | 2359441 | ⤷ Sign up for a Free Trial |
| Denmark | 1601349 | ⤷ Sign up for a Free Trial |
| Slovenia | 1908461 | ⤷ Sign up for a Free Trial |
| >Country | >Patent Number | >Estimated Expiration |
