FDA Orange Book

Generic for Lonsurf

Lonsurf contains trifluridine and tipiracil. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.

Source: FDA Orange Book data file dated 2026-10-09. Publisher page

Yes. The generic name for Lonsurf is trifluridine and tipiracil. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

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Lonsurf products in the Orange Book

Lonsurf products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
tablet, oral	EQ 6.14MG BASE;15MG	Marketed (Rx)	AB	2	AB
tablet, oral	EQ 8.19MG BASE;20MG	Marketed (Rx)	AB	2	AB

NDA 207981, held by TAIHO ONCOLOGY INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic trifluridine and tipiracil

Approved generic versions of Lonsurf
Company	ANDA	TE code	Approved	Strengths
NATCO PHARMA LTD	214008	AB (A-rated, therapeutically equivalent)	June 13, 2023	EQ 6.14MG BASE;15MG, EQ 8.19MG BASE;20MG
MSN LABORATORIES PRIVATE LTD	214024	AB (A-rated, therapeutically equivalent)	January 8, 2025	EQ 6.14MG BASE;15MG, EQ 8.19MG BASE;20MG

Lonsurf patents

Patents listed for Lonsurf
Patent	Expires	Covers	Use code	NDA
RE46284	September 22, 2029	Method of use	U-2503	207981
RE46284	September 22, 2029	Method of use	U-1751	207981
RE46284	September 22, 2029	Method of use	U-3656	207981
9527833	June 17, 2034	Drug substance, Drug product	None	207981
10457666	June 17, 2034	Drug substance, Drug product	None	207981
9943537	September 5, 2034	Method of use	U-3659	207981
10456399	February 3, 2037	Method of use	U-3657	207981
10456399	February 3, 2037	Method of use	U-3658	207981
10960004	February 3, 2037	Method of use	U-3657	207981
10960004	February 3, 2037	Method of use	U-3658	207981
12728130	February 3, 2037	Drug product	U-3657	207981
12728130	February 3, 2037	Drug product	U-3658	207981

Lonsurf exclusivity

Exclusivity listed for Lonsurf
Code	Meaning	Expires	NDA
ODE-229	Orphan drug exclusivity	February 22, 2026	207981

Lonsurf NDC codes

Questions

Is there a generic for Lonsurf?

Yes. The generic name for Lonsurf is trifluridine and tipiracil. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

What is the generic name for Lonsurf?

The active ingredient in Lonsurf is trifluridine and tipiracil, per the FDA Orange Book.

When does the Lonsurf patent expire?

The last patent listed for Lonsurf in the Orange Book expires February 3, 2037. A listed patent expiry date is not a generic launch date.

What does a therapeutic equivalence code mean?

In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.