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 patent protection?

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:	57
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
Sun Yat-sen University	Phase 2
The First Affiliated Hospital with Nanjing Medical University	Phase 2
Yonsei University	Phase 1/Phase 2

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
Natco	TIPIRACIL HYDROCHLORIDE AND TRIFLURIDINE	tipiracil hydrochloride; trifluridine	TABLET;ORAL	214008-002	Jun 13, 2023	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Taiho Oncology	LONSURF	tipiracil hydrochloride; trifluridine	TABLET;ORAL	207981-001	Sep 22, 2015	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Taiho Oncology	LONSURF	tipiracil hydrochloride; trifluridine	TABLET;ORAL	207981-001	Sep 22, 2015	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Taiho Oncology	LONSURF	tipiracil hydrochloride; trifluridine	TABLET;ORAL	207981-002	Sep 22, 2015	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Taiho Oncology	LONSURF	tipiracil hydrochloride; trifluridine	TABLET;ORAL	207981-001	Sep 22, 2015	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Taiho Oncology	LONSURF	tipiracil hydrochloride; trifluridine	TABLET;ORAL	207981-002	Sep 22, 2015	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
>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	⤷ Sign Up	⤷ Sign Up
Taiho Oncology	LONSURF	tipiracil hydrochloride; trifluridine	TABLET;ORAL	207981-001	Sep 22, 2015	⤷ Sign Up	⤷ Sign Up
Taiho Oncology	LONSURF	tipiracil hydrochloride; trifluridine	TABLET;ORAL	207981-002	Sep 22, 2015	⤷ Sign Up	⤷ Sign Up
Taiho Oncology	LONSURF	tipiracil hydrochloride; trifluridine	TABLET;ORAL	207981-001	Sep 22, 2015	⤷ Sign Up	⤷ Sign Up
>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
Singapore	10201710916Y	STABLE CRYSTAL FORM OF TIPIRACIL HYDROCHLORIDE AND CRYSTALLIZATION METHOD FOR THE SAME	⤷ Sign Up
Canada	2914999	CRISTAL STABILISE DE CHLORHYDRATE DE TIPIRACIL, ET SON PROCEDE DE CRISTALLISATION (STABLE CRYSTAL FORM OF TIPIRACIL HYDROCHLORIDE AND CRYSTALLIZATION METHOD FOR THE SAME)	⤷ Sign Up
Mexico	2015016986	FORMA DE CRISTAL ESTABLE DE CLORHIDRATO DE TIPIRACIL, Y METODO DE CRISTALIZACION DEL MISMO. (STABILIZED CRYSTAL OF TIPIRACIL HYDROCHLORIDE, AND CRYSTALLIZATION METHOD FOR SAME.)	⤷ Sign Up
Australia	2014282281	Stabilized crystal of tipiracil hydrochloride, and crystallization method for same	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2006080327		⤷ Sign Up
New Zealand	714090	Stable crystal form of tipiracil hydrochloride and crystallization method for the same	⤷ Sign Up
>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	300889	Netherlands	⤷ Sign Up	PRODUCT NAME: TRIFLURIDINE IN COMBINATIE MET TIPIRACILHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/16/1096 20160427
1849470	2017C/028	Belgium	⤷ Sign Up	PRODUCT NAME: LONSURF - TRIFLURIDINE/TIPIRACIL; AUTHORISATION NUMBER AND DATE: EU/1/16/1096 20160427
1849470	CA 2017 00036	Denmark	⤷ Sign Up	PRODUCT NAME: TRIFLURIDINE IN COMBINATION WITH TIPIRACIL OR A PHARMACEUTICALLY ACCEPTABLE SALT OF TIPIRACIL; REG. NO/DATE: EU/1/16/1096 20160427
1849470	PA2017024,C1849470	Lithuania	⤷ Sign Up	PRODUCT NAME: TRIFLURIDINAS/TIPIRACILAS; REGISTRATION NO/DATE: EU/1/16/1096 20160425
1849470	34/2017	Austria	⤷ Sign Up	PRODUCT NAME: TRIFLURIDIN / TIPIRACIL ODER DEREN PHARMAZEUTISCH WIRKSAMEN SALZE; REGISTRATION NO/DATE: EU/1/16/1096 (MITTEILUNG) 20160427
1849470	132017000102371	Italy	⤷ Sign Up	PRODUCT NAME: TRIFLURDINA IN COMBINAZIONE CON TIPIRACILE O UN SALE DI TIPIRACILE QUALE TIPIRACILE IDROCLORURO(LONSURF); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1096, 20160427
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.