DrugPatentWatch Database Preview
FETZIMA Drug Profile
Which patents cover Fetzima, and when can generic versions of Fetzima launch?
This drug has fifty-four patent family members in twenty-seven countries.
The generic ingredient in FETZIMA is levomilnacipran hydrochloride. There are nine drug master file entries for this compound. One supplier is 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: | 43 |
| Clinical Trials: | 5 |
| Patent Applications: | 9 |
| Drug Prices: | see details |
| DailyMed Link: | FETZIMA at DailyMed |
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 |
| 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)- |
| D02XOK |
| D10072 |
| D10133 |
| Dalcipran |
| DB08918 |
| F 2695 |
| F 2695 hydrochloride |
| F-2207 |
| F-2695 |
| f2-695 |
| F2695 |
| 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 |
| MFCD18433402 |
| Midalcipran hydrochloride |
| Milnacipram |
| Milnacipran ((1S-cis) hydrochloride) |
| Milnacipran (1S-cis) hydrochloride |
| Milnacipran HCl |
| Milnacipran hydrochloride |
| Milnacipran Hydrochloride 1.0 mg/ml in Methanol (as free base) |
| MolPort-019-939-251 |
| Savella |
| SCHEMBL1148742 |
| SCHEMBL1414867 |
| TN-912 |
| Toledomin |
| UGM0326TXX |
| UNII-371U2ZK31U |
| UNII-G56VK1HF36 component GJJFMKBJSRMPLA-DZGCQCFKSA-N |
| UNII-RNZ43O5WW5 component XNCDYJFPRPDERF-NQQJLSKUSA-N |
| UNII-UGM0326TXX |
| ZINC506 |
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 | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Allergan Sales Llc | FETZIMA | levomilnacipran hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 204168-002 | Jul 25, 2013 | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | Y | Y | ➤ Sign Up | ||
| Allergan Sales Llc | FETZIMA | levomilnacipran hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 204168-001 | Jul 25, 2013 | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Allergan Sales Llc | FETZIMA | levomilnacipran hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 204168-003 | Jul 25, 2013 | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
Paragraph IV (Patent) Challenges for FETZIMA
| Drugname | Dosage | Strength | RLD | Submissiondate |
|---|---|---|---|---|
| ➤ Subscribe | Extended-release Capsules | 20 mg, 40 mg, 80 mg and 120 mg | ➤ Subscribe | 2017-07-25 |
Non-Orange Book US Patents for FETZIMA
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration |
|---|---|---|
| 7,005,452 | Use of the dextrogyral enantiomer of milnacipran for the preparation of a drug | ➤ Sign Up |
| 7,074,833 | Use of the (1S,2R) enantiomer of milnacipran for the preparation of a drug | ➤ Sign Up |
| 9,259,403 | Crystalline forms of (1S,2R)-2-(amino methyl)-N,N-diethyl-1-phenyl cyclopropane carboxamide | ➤ Sign Up |
| Patent No. | Title | Estimated Patent Expiration |
