LEVOMILNACIPRAN HYDROCHLORIDE Drug Patent Profile
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Which patents cover Levomilnacipran Hydrochloride, and when can generic versions of Levomilnacipran Hydrochloride launch?
Levomilnacipran Hydrochloride is a drug marketed by Amneal Pharms Co, Aurobindo Pharma Ltd, Hikma, and Prinston Inc. and is included in four NDAs.
The generic ingredient in LEVOMILNACIPRAN HYDROCHLORIDE 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® Litigation and Generic Entry Outlook for Levomilnacipran Hydrochloride
A generic version of LEVOMILNACIPRAN HYDROCHLORIDE was approved as levomilnacipran hydrochloride by PRINSTON INC on March 20th, 2023.
Summary for LEVOMILNACIPRAN HYDROCHLORIDE
Recent Clinical Trials for LEVOMILNACIPRAN HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Allergan | Phase 3 |
| University of Ottawa | Phase 4 |
| Allergan | Phase 4 |
Pharmacology for LEVOMILNACIPRAN HYDROCHLORIDE
| Drug Class | Serotonin and Norepinephrine Reuptake Inhibitor |
| Mechanism of Action | Norepinephrine Uptake Inhibitors Serotonin Uptake Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for LEVOMILNACIPRAN HYDROCHLORIDE
Paragraph IV (Patent) Challenges for LEVOMILNACIPRAN HYDROCHLORIDE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| FETZIMA | Extended-release Capsules | levomilnacipran hydrochloride | 20 mg, 40 mg, 80 mg and 120 mg | 204168 | 6 | 2017-07-25 |
US Patents and Regulatory Information for LEVOMILNACIPRAN HYDROCHLORIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Amneal Pharms Co | LEVOMILNACIPRAN HYDROCHLORIDE | levomilnacipran hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 210790-001 | Feb 4, 2019 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Aurobindo Pharma Ltd | LEVOMILNACIPRAN HYDROCHLORIDE | levomilnacipran hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 210826-003 | Jan 6, 2023 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Amneal Pharms Co | LEVOMILNACIPRAN HYDROCHLORIDE | levomilnacipran hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 210790-004 | Feb 4, 2019 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
