MILNACIPRAN HYDROCHLORIDE Drug Patent Profile
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Which patents cover Milnacipran Hydrochloride, and when can generic versions of Milnacipran Hydrochloride launch?
Milnacipran Hydrochloride is a drug marketed by Amneal Pharms and Uspharma Windlas and is included in two NDAs.
The generic ingredient in MILNACIPRAN HYDROCHLORIDE is milnacipran hydrochloride. There are twenty-eight drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the milnacipran hydrochloride profile page.
Summary for MILNACIPRAN HYDROCHLORIDE
Recent Clinical Trials for MILNACIPRAN HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Mansoura University | N/A |
Yousra Hisham Abdel Fattah | N/A |
University of Ottawa | Phase 4 |
Pharmacology for MILNACIPRAN HYDROCHLORIDE
Drug Class | Serotonin and Norepinephrine Reuptake Inhibitor |
Mechanism of Action | Norepinephrine Uptake Inhibitors Serotonin Uptake Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for MILNACIPRAN HYDROCHLORIDE
Paragraph IV (Patent) Challenges for MILNACIPRAN HYDROCHLORIDE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
SAVELLA | Tablets | milnacipran hydrochloride | 12.5 mg, 25 mg, 50 mg, and 100 mg | 022256 | 8 | 2013-01-14 |
US Patents and Regulatory Information for MILNACIPRAN 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 | MILNACIPRAN HYDROCHLORIDE | milnacipran hydrochloride | TABLET;ORAL | 205081-001 | Apr 22, 2016 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Uspharma Windlas | MILNACIPRAN HYDROCHLORIDE | milnacipran hydrochloride | TABLET;ORAL | 205071-003 | Jan 27, 2016 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Amneal Pharms | MILNACIPRAN HYDROCHLORIDE | milnacipran hydrochloride | TABLET;ORAL | 205081-004 | Apr 22, 2016 | 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 |