Phytonadione - Generic Drug Details
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What are the generic drug sources for phytonadione and what is the scope of patent protection?
Phytonadione
is the generic ingredient in five branded drugs marketed by Pai Holdings Pharm, Roche, Cipla, Dr Reddys, Glaxosmithkline, Intl Medication, Hospira, Bausch, Agnitio, Amneal Pharms Co, Sciegen Pharms Inc, and Zydus Lifesciences, and is included in fifteen NDAs. Additional information is available in the individual branded drug profile pages.There are ten drug master file entries for phytonadione. Seventeen suppliers are listed for this compound.
Summary for phytonadione
US Patents: | 0 |
Tradenames: | 5 |
Applicants: | 12 |
NDAs: | 15 |
Drug Master File Entries: | 10 |
Finished Product Suppliers / Packagers: | 17 |
Raw Ingredient (Bulk) Api Vendors: | 103 |
Clinical Trials: | 7 |
Patent Applications: | 5,478 |
Drug Prices: | Drug price trends 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 |
---|---|
University of Sydney | Phase 3 |
Australasian Kidney Trials Network | Phase 3 |
Waitemata District Health Board | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Hospira | VITAMIN K1 | phytonadione | INJECTABLE;INJECTION | 087955-001 | Jul 25, 1983 | AB1 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Bausch | MEPHYTON | phytonadione | TABLET;ORAL | 010104-003 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Dr Reddys | PHYTONADIONE | phytonadione | INJECTABLE;INJECTION | 207719-001 | May 22, 2019 | AB1 | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Glaxosmithkline | PHYTONADIONE | phytonadione | INJECTABLE;INJECTION | 084060-002 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Hospira | VITAMIN K1 | phytonadione | INJECTABLE;INJECTION | 087954-001 | Jul 25, 1983 | BP | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Cipla | PHYTONADIONE | phytonadione | INJECTABLE;INJECTION | 214596-002 | Apr 22, 2022 | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
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