PHYTONADIONE Drug Patent Profile
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Which patents cover Phytonadione, and what generic alternatives are available?
Phytonadione is a drug marketed by Alembic, Amneal, Baxter Hlthcare Corp, Caplin, Cipla, Dr Reddys, Gland, Glaxosmithkline, Intl Medication, Orbicular, Sunny, Agnitio, Amneal Pharms Co, Hikma, Sciegen Pharms, Sinotherapeutics Inc, and Zydus Lifesciences. and is included in twenty-one NDAs.
The generic ingredient in PHYTONADIONE is phytonadione. There are ten drug master file entries for this compound. Thirty 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.
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Questions you can ask:
- What is the 5 year forecast for PHYTONADIONE?
- What are the global sales for PHYTONADIONE?
- What is Average Wholesale Price for PHYTONADIONE?
Summary for PHYTONADIONE
| US Patents: | 0 |
| Applicants: | 17 |
| NDAs: | 21 |
| Finished Product Suppliers / Packagers: | 29 |
| Raw Ingredient (Bulk) Api Vendors: | 1 |
| Clinical Trials: | 7 |
| Patent Applications: | 3,600 |
| 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 |
|---|---|
| Salford Royal NHS Foundation Trust | Phase 3 |
| University of Sydney | Phase 3 |
| Australasian Kidney Trials Network | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Alembic | PHYTONADIONE | phytonadione | INJECTABLE;INJECTION | 216444-001 | Sep 8, 2025 | AB1 | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Sunny | PHYTONADIONE | phytonadione | INJECTABLE;INJECTION | 215090-001 | Jan 9, 2026 | AB1 | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Zydus Lifesciences | PHYTONADIONE | phytonadione | TABLET;ORAL | 210189-001 | Feb 20, 2019 | AB | RX | No | 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 |
