FDA Orange Book

Generic for Spiriva

Spiriva contains tiotropium bromide. 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 Spiriva is tiotropium bromide. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

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Spiriva products in the Orange Book

Spiriva products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
powder, inhalation	EQ 0.018MG BASE/INH	Marketed (Rx)	AB	1	AB

NDA 021395, held by BOEHRINGER INGELHEIM PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic tiotropium bromide

Approved generic versions of Spiriva
Company	ANDA	TE code	Approved	Strengths
LUPIN INC	211287	AB (A-rated, therapeutically equivalent)	June 20, 2023	EQ 0.018MG BASE/INH

Spiriva patents

Patents listed for Spiriva
Patent	Expires	Covers	Use code	NDA
8022082	January 19, 2026	Drug product	U-1186	021395
8022082*PED	July 19, 2026	Method of use	None	021395

Spiriva NDC codes

Questions

Is there a generic for Spiriva?

Yes. The generic name for Spiriva is tiotropium bromide. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

What is the generic name for Spiriva?

The active ingredient in Spiriva is tiotropium bromide, per the FDA Orange Book.

When does the Spiriva patent expire?

The last patent listed for Spiriva in the Orange Book expires July 19, 2026. 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.