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MEPHYTON Drug Profile
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Which patents cover Mephyton, and what generic alternatives are available?
Mephyton is a drug marketed by Bausch and is included in one NDA.
The generic ingredient in MEPHYTON is phytonadione. There are ten drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the phytonadione profile page.
US ANDA Litigation and Generic Entry Outlook for Mephyton
A generic version of MEPHYTON was approved as phytonadione by AMNEAL PHARMS CO on May 11th, 2018.
Summary for MEPHYTON
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 4 |
| Bulk Api Vendors: | 29 |
| Clinical Trials: | 1 |
| Patent Applications: | 1,009 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for MEPHYTON |
| Drug Sales Revenues: | Drug sales revenues for MEPHYTON |
| What excipients (inactive ingredients) are in MEPHYTON? | MEPHYTON excipients list |
| DailyMed Link: | MEPHYTON at DailyMed |
Recent Clinical Trials for MEPHYTON
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of North Carolina, Chapel Hill | N/A |
Pharmacology for MEPHYTON
| Drug Class | Vitamin K Warfarin Reversal Agent |
| Physiological Effect | Increased Prothrombin Activity Reversed Anticoagulation Activity |
US Patents and Regulatory Information for MEPHYTON
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Bausch | MEPHYTON | phytonadione | TABLET;ORAL | 010104-003 | Approved Prior to Jan 1, 1982 | AB | RX | Yes | Yes | 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 |
