FDA Orange Book

Generic for Dexilant

Dexilant contains dexlansoprazole. 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 Dexilant is dexlansoprazole. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

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Dexilant products in the Orange Book

Dexilant products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
capsule, delayed release, oral	30MG	Marketed (Rx)	AB	4	AB
capsule, delayed release, oral	60MG	Marketed (Rx)	AB	4	AB

NDA 022287, held by TAKEDA PHARMACEUTICALS USA INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic dexlansoprazole

Approved generic versions of Dexilant
Company	ANDA	TE code	Approved	Strengths
PH HEALTH LTD	202294	AB (A-rated, therapeutically equivalent)	June 16, 2022	30MG, 60MG
TWI PHARMACEUTICALS INC	202666	AB (A-rated, therapeutically equivalent)	September 16, 2022	30MG, 60MG
MYLAN PHARMACEUTICALS INC	205205	AB (A-rated, therapeutically equivalent)	January 19, 2024	30MG, 60MG
ALEMBIC PHARMACEUTICALS LTD	219115	AB (A-rated, therapeutically equivalent)	November 12, 2025	30MG, 60MG

Dexilant patents

Patents listed for Dexilant
Patent	Expires	Covers	Use code	NDA
9238029	January 17, 2026	Drug product	None	022287
8461187	January 17, 2026	Drug product	None	022287
9011926	February 24, 2026	Drug product	None	022287
8461187*PED	July 17, 2026	Method of use	None	022287
7790755	August 2, 2026	Drug product	None	022287
8105626	September 27, 2026	Drug product	None	022287
7790755*PED	February 2, 2027	Method of use	None	022287
8105626*PED	March 27, 2027	Method of use	None	022287
8871273	January 11, 2028	Drug product	None	022287
8173158	March 17, 2030	Method of use	U-951	022287
8173158	March 17, 2030	Method of use	U-949	022287
8173158	March 17, 2030	Method of use	U-950	022287
8173158*PED	September 17, 2030	Method of use	None	022287
9233103	March 5, 2032	Method of use	U-1805	022287

Dexilant NDC codes

Questions

Is there a generic for Dexilant?

Yes. The generic name for Dexilant is dexlansoprazole. 4 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 Dexilant?

The active ingredient in Dexilant is dexlansoprazole, per the FDA Orange Book.

When does the Dexilant patent expire?

The last patent listed for Dexilant in the Orange Book expires March 5, 2032. 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.