PHYTONADIONE Drug Patent Profile
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Which patents cover Phytonadione, and what generic alternatives are available?
Phytonadione is a drug marketed by Cipla, Dr Reddys, Glaxosmithkline, Intl Medication, Agnitio, Amneal Pharms Co, Sciegen Pharms Inc, and Zydus. and is included in nine NDAs.
The generic ingredient in PHYTONADIONE is phytonadione. There are ten drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the phytonadione profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Phytonadione
A generic version of PHYTONADIONE was approved as phytonadione by AMNEAL PHARMS CO on May 11th, 2018.
Summary for PHYTONADIONE
US Patents: | 0 |
Applicants: | 8 |
NDAs: | 9 |
Finished Product Suppliers / Packagers: | 15 |
Raw Ingredient (Bulk) Api Vendors: | 103 |
Clinical Trials: | 7 |
Patent Applications: | 3,627 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for PHYTONADIONE |
What excipients (inactive ingredients) are in PHYTONADIONE? | PHYTONADIONE excipients list |
DailyMed Link: | PHYTONADIONE at DailyMed |
Recent Clinical Trials for PHYTONADIONE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Waitemata District Health Board | Phase 3 |
Salford Royal NHS Foundation Trust | Phase 3 |
University of Sydney | Phase 3 |
Pharmacology for PHYTONADIONE
Drug Class | Vitamin K Warfarin Reversal Agent |
Physiological Effect | Increased Prothrombin Activity Reversed Anticoagulation Activity |
US Patents and Regulatory Information for PHYTONADIONE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Cipla | PHYTONADIONE | phytonadione | INJECTABLE;INJECTION | 212424-001 | Apr 22, 2022 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Glaxosmithkline | PHYTONADIONE | phytonadione | INJECTABLE;INJECTION | 084060-002 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Cipla | PHYTONADIONE | phytonadione | INJECTABLE;INJECTION | 214596-002 | Apr 22, 2022 | RX | No | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Zydus | PHYTONADIONE | phytonadione | TABLET;ORAL | 210189-001 | Feb 20, 2019 | AB | RX | No | Yes | ⤷ 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 |