Is Alupent still available?

Alupent (NDA 015874) is listed as Discontinued in the FDA Orange Book — it is no longer marketed. A discontinued status is not, by itself, a determination that the drug was withdrawn for safety or effectiveness.

Does Alupent have a generic?

Yes. The Orange Book lists 31 approved generic (ANDA) applications sharing Alupent's active ingredient (Metaproterenol Sulfate). A generic with an "A"-rated therapeutic-equivalence code is considered substitutable for the brand.

What is Alupent's FDA application number?

Alupent is approved under NDA 015874, held by Boehringer Ingelheim.

Orange Book product · Brand (NDA)

Alupent

Metaproterenol Sulfate

Brand (NDA)NDA 015874Discontinued Boehringer Ingelheim

Approved

Approved Prior to Jan 1, 1982

Application

Brand (NDA)

TE code

Not listed

Listed patents

Alupent (Metaproterenol Sulfate) is Boehringer Ingelheim's brand-name drug, approved by the FDA under NDA 015874. Its marketing status is listed as discontinued; a discontinued listing is not, by itself, a finding that the drug was withdrawn for safety or effectiveness. 31 approved generics share this drug's active ingredient.

Sourced from the FDA Orange Book

Approval, patents, exclusivity

Key dates

No patent or exclusivity dates are listed for this product.

FDA product record

Pharmaceutical detail

Active ingredient

METAPROTERENOL SULFATE

Strength

20MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 015874

Product number

001

Marketing status

Discontinued

Reference listed drug (RLD)

Reference standard (RS)

Same application

Other strengths in NDA 015874

10MGTABLET

Brand + generics

Active-ingredient family

This is a brand (NDA) product. Other products sharing this active ingredient are listed below.

View full Metaproterenol Sulfate family

Orange Book patent file

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Alupent — frequently asked questions

Approval, therapeutic equivalence, patents, and exclusivity for this product, from the FDA Orange Book.

Built directly from the FDA Orange Book data file. This product page links back to the Metaproterenol Sulfate active-ingredient family, which is the canonical reference for generics, patents, and exclusivity across all strengths.

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