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:	6,778
Drug Prices:	Drug price trends for trifluridine
What excipients (inactive ingredients) are in trifluridine?	trifluridine excipients list
DailyMed Link:	trifluridine at DailyMed

See drug prices for trifluridine

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

See all trifluridine clinical trials

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

Antimetabolites
Antiviral Agents

Anatomical Therapeutic Chemical (ATC) Classes for trifluridine

S01AD	Antivirals
S01A	ANTIINFECTIVES
S01	OPHTHALMOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for trifluridine

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Glossary

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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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