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Milnacipran hydrochloride - Generic Drug Details
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What are the generic sources for milnacipran hydrochloride and what is the scope of patent protection?
Milnacipran hydrochloride
is 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
International Patents: | 49 |
US Patents: | 4 |
Tradenames: | 2 |
Applicants: | 3 |
NDAs: | 3 |
Drug Master File Entries: | 28 |
Suppliers / Packagers: | 4 |
Bulk Api Vendors: | 152 |
Clinical Trials: | 54 |
Patent Applications: | 539 |
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
Sponsor | Phase |
---|---|
Yousra Hisham Abdel Fattah | N/A |
Allergan | Phase 4 |
University of Ottawa | Phase 4 |
Generic filers with tentative approvals for MILNACIPRAN HYDROCHLORIDE
Applicant | Application No. | Strength | Dosage Form |
Start Trial | Start Trial | 25MG | TABLET;ORAL |
Start Trial | Start Trial | 12.5MG | TABLET;ORAL |
Start Trial | Start Trial | 100MG | TABLET;ORAL |
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 |
Paragraph IV (Patent) Challenges for MILNACIPRAN HYDROCHLORIDE
Tradename | Dosage | Ingredient | NDA | Submissiondate |
---|---|---|---|---|
SAVELLA | TABLET;ORAL | milnacipran hydrochloride | 022256 | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Uspharma | MILNACIPRAN HYDROCHLORIDE | milnacipran hydrochloride | TABLET;ORAL | 205071-004 | Jan 27, 2016 | DISCN | No | No | 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 | ||||
Allergan | SAVELLA | milnacipran hydrochloride | TABLET;ORAL | 022256-004 | Jan 14, 2009 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
Allergan | SAVELLA | milnacipran hydrochloride | TABLET;ORAL | 022256-002 | Jan 14, 2009 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
Uspharma | MILNACIPRAN HYDROCHLORIDE | milnacipran hydrochloride | TABLET;ORAL | 205071-003 | Jan 27, 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 |
International Patents for milnacipran hydrochloride
Country | Patent Number | Estimated Expiration |
---|---|---|
Brazil | PI0617541 | Start Trial |
Tunisia | SN08129 | Start Trial |
Austria | 552856 | Start Trial |
Singapore | 183735 | Start Trial |
Costa Rica | 9882 | Start Trial |
Japan | 2012193216 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
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