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FETZIMA Drug 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.
US ANDA Litigation and Generic Entry Outlook for Fetzima
There have been eight 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 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 60 |
| Clinical Trials: | 6 |
| Patent Applications: | 34 |
| Drug Prices: | Drug price information for FETZIMA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for FETZIMA |
| DailyMed Link: | FETZIMA at DailyMed |
Recent Clinical Trials for FETZIMA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Allergan | Phase 4 |
| University of Ottawa | Phase 4 |
| University of California, Los Angeles | Phase 3 |
Pharmacology for FETZIMA
| Drug Class | Serotonin and Norepinephrine Reuptake Inhibitor |
| Mechanism of Action | Norepinephrine Uptake Inhibitors Serotonin Uptake Inhibitors |
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
| 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 | 204168-001 | Jul 25, 2013 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Allergan | FETZIMA | levomilnacipran hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 204168-002 | Jul 25, 2013 | RX | Yes | No | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Allergan | FETZIMA | levomilnacipran hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 204168-001 | Jul 25, 2013 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| >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 FETZIMA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Austria | 501716 | Start Trial |
| Canada | 2514948 | Start Trial |
| Denmark | 1601349 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
