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TIPIRACIL HYDROCHLORIDE AND TRIFLURIDINE

ANDA

TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE | A214008 | NATCO PHARMA LTD

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: LONSURF(TE code: AB)

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Taiho Pharmaceutical Co., Ltd. et al v. Natco Pharma Ltd. et al 1:2019cv02368 3 patentsANDA 214008trifluridine and tipiracil	D. Del.	2019-12-30	Terminated 2024-04-11	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jul 13, 2023	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

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#001 — EQ 6.14MG BASE;15MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jun 13, 2023

No patent or exclusivity listings for this strength.

#002 — EQ 8.19MG BASE;20MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jun 13, 2023