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Last Updated: April 26, 2024

Tipiracil hydrochloride; trifluridine - Generic Drug Details

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What are the generic drug sources for tipiracil hydrochloride; trifluridine and what is the scope of freedom to operate?

Tipiracil hydrochloride; trifluridine is the generic ingredient in two branded drugs marketed by Taiho Oncology and Natco, and is included in two NDAs. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Tipiracil hydrochloride; trifluridine has one hundred and eighteen patent family members in thirty-three countries.

One supplier is listed for this compound.

Summary for tipiracil hydrochloride; trifluridine

International Patents:	118
US Patents:	6
Tradenames:	2
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	1
Clinical Trials:	54
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for tipiracil hydrochloride; trifluridine
DailyMed Link:	tipiracil hydrochloride; trifluridine at DailyMed

Recent Clinical Trials for tipiracil hydrochloride; trifluridine

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Yonsei University	Phase 1/Phase 2
Merck Sharp & Dohme LLC	Phase 3
Bristol-Myers Squibb	Phase 3

See all tipiracil hydrochloride; trifluridine clinical trials

Pharmacology for tipiracil hydrochloride; trifluridine

Drug Class	Nucleoside Analog Antiviral Nucleoside Metabolic Inhibitor Thymidine Phosphorylase Inhibitor
Mechanism of Action	Nucleic Acid Synthesis Inhibitors Thymidine Phosphorylase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for tipiracil hydrochloride; trifluridine

S01AD	Antivirals
S01A	ANTIINFECTIVES
S01	OPHTHALMOLOGICALS
S	Sensory organs

Paragraph IV (Patent) Challenges for TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
LONSURF	Tablets	tipiracil hydrochloride; trifluridine	15 mg/6.14 mg and 20 mg/8.19 mg	207981	4	2019-09-23

US Patents and Regulatory Information for tipiracil hydrochloride; 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
Taiho Oncology	LONSURF	tipiracil hydrochloride; trifluridine	TABLET;ORAL	207981-001	Sep 22, 2015	AB	RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Taiho Oncology	LONSURF	tipiracil hydrochloride; trifluridine	TABLET;ORAL	207981-002	Sep 22, 2015	AB	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Taiho Oncology	LONSURF	tipiracil hydrochloride; trifluridine	TABLET;ORAL	207981-002	Sep 22, 2015	AB	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y	Y		⤷ 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

Expired US Patents for tipiracil hydrochloride; trifluridine

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Taiho Oncology	LONSURF	tipiracil hydrochloride; trifluridine	TABLET;ORAL	207981-002	Sep 22, 2015	⤷ Try a Trial	⤷ Try a Trial
Taiho Oncology	LONSURF	tipiracil hydrochloride; trifluridine	TABLET;ORAL	207981-002	Sep 22, 2015	⤷ Try a Trial	⤷ Try a Trial
Taiho Oncology	LONSURF	tipiracil hydrochloride; trifluridine	TABLET;ORAL	207981-001	Sep 22, 2015	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for tipiracil hydrochloride; trifluridine

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Country	Patent Number	Title	Estimated Expiration
Hong Kong	1203071	地匹福林鹽酸鹽的穩定型晶體及其結晶化方法 (STABILIZED CRYSTAL OF TIPIRACIL HYDROCHLORIDE, AND CRYSTALLIZATION METHOD FOR SAME)	⤷ Try a Trial
South Korea	20160050026	항 종양제 및 항 종양 효과 증강제 (ANTITUMOR AGENT AND ANTITUMOR EFFECT ENHANCER)	⤷ Try a Trial
Russian Federation	2674441	СТАБИЛЬНАЯ КРИСТАЛЛИЧЕСКАЯ ФОРМА ТИПИРАЦИЛА ГИДРОХЛОРИДА И СПОСОБ ЕЕ КРИСТАЛЛИЗАЦИИ (STABLE CRYSTALLINE FORM OF TIPIRACIL HYDROCHLORIDE AND METHOD FOR ITS CRYSTALLIZATION)	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for tipiracil hydrochloride; trifluridine

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1849470	PA2017024	Lithuania	⤷ Try a Trial	PRODUCT NAME: TRIFLURIDINAS/TIPIRACILAS; REGISTRATION NO/DATE: EU/1/16/1096 20160425
1849470	322 20-2017	Slovakia	⤷ Try a Trial	PRODUCT NAME: TRIFLURIDIN/TIPIRACIL VO VSETKYCH FORMACH CHRA- NENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/16/1096 20160427
1849470	SPC/GB17/049	United Kingdom	⤷ Try a Trial	PRODUCT NAME: TRIFLURIDINE WITH TIPACRIL HYDROCHLORIDE; REGISTERED: UK EU/1/16/1096/001(NI) 20160427; UK EU/1/16/1096/002(NI) 20160427; UK EU/1/16/1096/003(NI) 20160427; UK EU/1/16/1096/004(NI) 20160427; UK EU/1/16/1096/005(NI) 20160427; UK EU/1/16/1096/006(NI) 20160427; UK PLGB 05815/0112 20160427; UK PLGB 05815/0113 20160427
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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