Trifluridine - Generic Drug Details
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What are the generic sources for trifluridine and what is the scope of patent protection?
Trifluridine
is the generic ingredient in two branded drugs marketed by Hikma, Sandoz, and Monarch Pharms, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.There are two drug master file entries for trifluridine. One supplier is listed for this compound. There is one tentative approval for this compound.
Summary for trifluridine
US Patents: | 0 |
Tradenames: | 2 |
Applicants: | 3 |
NDAs: | 3 |
Drug Master File Entries: | 2 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 91 |
Clinical Trials: | 65 |
Patent Applications: | 6,767 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends for trifluridine |
What excipients (inactive ingredients) are in trifluridine? | trifluridine excipients list |
DailyMed Link: | trifluridine at DailyMed |
Recent Clinical Trials for trifluridine
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
The First Affiliated Hospital with Nanjing Medical University | Phase 2 |
Sun Yat-sen University | Phase 2 |
Yonsei University | Phase 1/Phase 2 |
Generic filers with tentative approvals for TRIFLURIDINE
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 20MG/8.19MG | TABLET;ORAL |
⤷ Sign Up | ⤷ Sign Up | 15MG/6.14MG | 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 trifluridine
Drug Class | Nucleoside Analog Antiviral Nucleoside Metabolic Inhibitor |
Mechanism of Action | Nucleic Acid Synthesis Inhibitors |
Medical Subject Heading (MeSH) Categories for trifluridine
Anatomical Therapeutic Chemical (ATC) Classes for trifluridine
US Patents and Regulatory Information for trifluridine
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sandoz | TRIFLURIDINE | trifluridine | SOLUTION/DROPS;OPHTHALMIC | 074311-001 | Oct 6, 1995 | AT | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Monarch Pharms | VIROPTIC | trifluridine | SOLUTION/DROPS;OPHTHALMIC | 018299-001 | Approved Prior to Jan 1, 1982 | AT | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Hikma | TRIFLURIDINE | trifluridine | SOLUTION/DROPS;OPHTHALMIC | 205438-001 | Jul 28, 2017 | DISCN | No | No | ⤷ 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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