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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
Fetzima was eligible for patent challenges on December 31, 1968.
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: | 56 |
| 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 |
Recent Litigation for FETZIMA
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| ALLERGAN SALES, LLC v. MICRO LABS LTD. | 2019-04-12 |
| FOREST LABORATORIES, LLC v. AMNEAL PHARMACEUTICALS LLC | 2017-11-15 |
| FOREST LABORATORIES, LLC v. AUROBINDO PHARMA USA, INC. | 2017-11-15 |
Pharmacology for FETZIMA
| Drug Class | Serotonin and Norepinephrine Reuptake Inhibitor |
| Mechanism of Action | Norepinephrine Uptake Inhibitors Serotonin Uptake Inhibitors |
Synonyms for FETZIMA
| (+)-(1S,2R)-MILNACIPRAN |
| (+)-Milnacipran |
| (1R,2S)-rel-2-(Aminomethyl)-N,N-diethyl-1-phenylcyclopropanecarboxamide hydrochloride |
| (1R,2S)-rel-2-(Aminomethyl)-N,N-diethyl-1-phenylcyclopropanecarboxamide monohydrochloride |
| (1S-cis)-Milnacipran Hydrochloride |
| (1S,2R)-2-(aminomethyl)-N,N-diethyl-1-phenylcyclopropane-1-carboxamide |
| (1S,2R)-2-(aminomethyl)-N,N-diethyl-1-phenylcyclopropane-1-carboxamide hydrochloride |
| (1S,2R)-2-(aminomethyl)-N,N-diethyl-1-phenylcyclopropane-1-carboxamide;hydrochloride |
| (1S,2R)-2-(aminomethyl)-N,N-diethyl-1-phenylcyclopropanecarboxamide |
| (1S,2R)-2-(Aminomethyl)-N,N-diethyl-1-phenylcyclopropanecarboxamide Hydrochloride |
| (1S,2R)-2-Aminomethyl-1-phenyl-cyclopropanecarboxylic acid diethylamide |
| (1S,2R)-milnacipran |
| (1S,2R)-Milnacipran Hydrochloride |
| 101152-94-7 |
| 152M947 |
| 175131-60-9 |
| 371U2ZK31U |
| 96847-54-0 |
| 96847-55-1 |
| AC1OCEN6 |
| AC1OCEN8 |
| AK481450 |
| AKOS025311514 |
| API0003393 |
| AS-12868 |
| AT-28508 |
| BDBM50032379 |
| C15H22N2O.HCl |
| CCG-231710 |
| CHEBI:136040 |
| CHEMBL2105732 |
| CHEMBL99946 |
| cis-(+)-Milnacipran Hydrochloride |
| cis-2-(Aminomethyl)-N,N-diethyl-1-phenylcyclopropanecarboxamide Hydrochloride |
| CS-4972 |
| Cyclopropanecarboxamide, 2-(aminomethyl)-N,N-diethyl-1-phenyl-, (1S,2R)- |
| D10072 |
| D10133 |
| Dalcipran |
| DB08918 |
| F 2695 |
| F 2695 hydrochloride |
| F-2207 |
| F-2695 |
| f2-695 |
| Fetzima (TN) |
| GJJFMKBJSRMPLA-DZGCQCFKSA-N |
| GTPL7435 |
| HY-B0168B |
| Ixel |
| J10386 |
| Joncia |
| K-0218 |
| Levomilnacipran |
| Levomilnacipran (USAN/INN) |
| Levomilnacipran [USAN:INN] |
| Levomilnacipran HCl |
| LEVOMILNACIPRAN HYDROCHLORIDE |
| Levomilnacipran hydrochloride (USAN) |
| Levomilnacipran hydrochloride [USAN] |
| M2133 |
| MFCD00901293 |
| Midalcipran hydrochloride |
| Milnacipram |
| Milnacipran ((1S-cis) hydrochloride) |
| Milnacipran HCl |
| Milnacipran hydrochloride |
| Milnacipran Hydrochloride 1.0 mg/ml in Methanol (as free base) |
| MolPort-019-939-251 |
| rac-Milnacipran Hydrochloride |
| Savella |
| SB17447 |
| SB17448 |
| SCHEMBL1148742 |
| SCHEMBL1414867 |
| TN-912 |
| Toledomin |
| UGM0326TXX |
| UNII-371U2ZK31U |
| UNII-G56VK1HF36 component GJJFMKBJSRMPLA-DZGCQCFKSA-N |
| UNII-RNZ43O5WW5 component XNCDYJFPRPDERF-NQQJLSKUSA-N |
| UNII-UGM0326TXX |
| ZINC506 |
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 | ||||
| Allergan | FETZIMA | levomilnacipran hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 204168-003 | 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 | Start Trial | ||||
| Allergan | FETZIMA | levomilnacipran hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 204168-004 | Jul 25, 2013 | RX | Yes | Yes | 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 |
|---|---|---|
| Australia | 2004216452 | Start Trial |
| European Patent Office | 1908461 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2011088331 | Start Trial |
| Germany | 602004031893 | Start Trial |
| Austria | 401872 | Start Trial |
| Norway | 333987 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
