DrugPatentWatch Database Preview
FETZIMA Drug Profile
Which patents cover Fetzima, and when can generic versions of Fetzima launch?
Fetzima is a drug marketed by Allergan Sales Llc 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.
Summary for FETZIMA
| International Patents: | 54 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 55 |
| 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 |
|---|---|
| University of Ottawa | Phase 4 |
| Allergan | 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. AUROBINDO PHARMA USA, INC. | 2017-11-15 |
| FOREST LABORATORIES, LLC v. AMNEAL PHARMACEUTICALS LLC | 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 Sales Llc | FETZIMA | levomilnacipran hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 204168-001 | Jul 25, 2013 | RX | Yes | No | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Allergan Sales Llc | FETZIMA | levomilnacipran hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 204168-003 | Jul 25, 2013 | RX | Yes | No | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Allergan Sales Llc | FETZIMA | levomilnacipran hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 204168-002 | Jul 25, 2013 | RX | Yes | No | Start Trial | Start Trial | Y | Y | 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 | 401872 | Start Trial |
| Australia | 2004216452 | Start Trial |
| Poland | 219671 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
