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Milnacipran hydrochlorideis the generic ingredient in two branded drugs marketed by Amneal Pharms, Uspharma, and Allergan, and is included in three NDAs. There are four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.
Milnacipran hydrochloride has forty-nine patent family members in twenty-seven countries.
There are twenty-eight drug master file entries for milnacipran hydrochloride. Four suppliers are listed for this compound. There are five tentative approvals for this compound.
Summary for milnacipran hydrochloride
|Drug Master File Entries:||28|
|Suppliers / Packagers:||4|
|Bulk Api Vendors:||147|
|Formulation / Manufacturing:||see details|
|Patent Litigation and PTAB cases:||See patent lawsuits and PTAB cases for milnacipran hydrochloride|
|What excipients (inactive ingredients) are in milnacipran hydrochloride?||milnacipran hydrochloride excipients list|
|DailyMed Link:||milnacipran hydrochloride at DailyMed|
Recent Clinical Trials for milnacipran hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
|Yousra Hisham Abdel Fattah||N/A|
|University of Ottawa||Phase 4|
Generic filers with tentative approvals for MILNACIPRAN HYDROCHLORIDE
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for milnacipran hydrochloride
|Drug Class||Serotonin and Norepinephrine Reuptake Inhibitor |
|Mechanism of Action||Norepinephrine Uptake Inhibitors |
Serotonin Uptake Inhibitors
|Applicant||Tradename||Generic Name||Dosage||NDA||Approval Date||TE||Type||RLD||RS||Patent No.||Patent Expiration||Product||Substance||Delist Req.||Exclusivity Expiration|
|Allergan||SAVELLA||milnacipran hydrochloride||TABLET;ORAL||022256-002||Jan 14, 2009||RX||Yes||No||Start Trial||Start Trial||Start Trial|
|Allergan||SAVELLA||milnacipran hydrochloride||TABLET;ORAL||022256-003||Jan 14, 2009||RX||Yes||Yes||Start Trial||Start Trial||Start Trial|
|Amneal Pharms||MILNACIPRAN HYDROCHLORIDE||milnacipran hydrochloride||TABLET;ORAL||205081-001||Apr 22, 2016||DISCN||No||No||Start Trial||Start Trial||Start Trial|
|Amneal Pharms||MILNACIPRAN HYDROCHLORIDE||milnacipran hydrochloride||TABLET;ORAL||205081-004||Apr 22, 2016||DISCN||No||No||Start Trial||Start Trial||Start Trial|
|Allergan||SAVELLA||milnacipran hydrochloride||TABLET;ORAL||022256-001||Jan 14, 2009||RX||Yes||No||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|
|Country||Patent Number||Estimated Expiration|
|Russian Federation||2437661||Start Trial|
|New Zealand||593199||Start Trial|
|Georgia, Republic of||P20125595||Start Trial|
|>Country||>Patent Number||>Estimated Expiration|
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