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FDA Orange Book · active-ingredient family

Ipratropium bromide

Ipratropium bromide is approved as 5 brand and 28 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:ATROVENT HFA · NDA 021527

5

Brand (NDA)

28

Generics (ANDA)

1

Listed patents

1

Exclusivity periods

Brand (NDA) products · aerosol, metered, solution, spray, metered

ProductApplicantApplicationTEApproved
ATROVENT HFARLDBOEHRINGER INGELHEIMNDA 021527ABNov 27, 2004
ATROVENTRLDBOEHRINGER INGELHEIMNDA 020393—Oct 20, 1995
ATROVENTRLDBOEHRINGER INGELHEIMNDA 020394—Oct 20, 1995
ATROVENTRLDBOEHRINGER INGELHEIMNDA 020228—Sep 29, 1993
ATROVENTBOEHRINGER INGELHEIMNDA 019085—Dec 29, 1986

Generic (ANDA) products (28)

ProductApplicantApplicationTEApproved
IPRATROPIUM BROMIDEARMSTRONG PHARMSANDA 217953ABFeb 23, 2026
IPRATROPIUM BROMIDELUPINANDA 217912ABFeb 07, 2025
IPRATROPIUM BROMIDELUPINANDA 217886ABJan 27, 2025
IPRATROPIUM BROMIDERUBICON RESEARCHANDA 219222ABJan 14, 2025
IPRATROPIUM BROMIDERUBICON RESEARCHANDA 219221ABNov 15, 2024
IPRATROPIUM BROMIDEAMNEALANDA 215104ABAug 16, 2022
IPRATROPIUM BROMIDEAMNEALANDA 215105ABAug 16, 2022
IPRATROPIUM BROMIDESUN PHARMANDA 207903—Jan 03, 2017
IPRATROPIUM BROMIDELUOXIN AUROVITASANDA 206543ANOct 27, 2016
IPRATROPIUM BROMIDELANDELA PHARMANDA 077072—Jul 19, 2005
IPRATROPIUM BROMIDEWATSON LABSANDA 076291—May 09, 2005
IPRATROPIUM BROMIDEHIKMAANDA 076664ABNov 05, 2003
IPRATROPIUM BROMIDEHIKMAANDA 076598ABNov 05, 2003
IPRATROPIUM BROMIDEAPOTEX INCANDA 076156ABApr 18, 2003
IPRATROPIUM BROMIDEAPOTEX INCANDA 076155ABApr 18, 2003
IPRATROPIUM BROMIDEAUROBINDO PHARMA USAANDA 075552—Mar 31, 2003
IPRATROPIUM BROMIDEAUROBINDO PHARMA USAANDA 075553—Mar 31, 2003
IPRATROPIUM BROMIDEBAUSCHANDA 076025ABMar 31, 2003
IPRATROPIUM BROMIDEBAUSCHANDA 076103ABMar 31, 2003
IPRATROPIUM BROMIDEROXANEANDA 075867—Jul 22, 2002
IPRATROPIUM BROMIDEBAUSCHANDA 075835—Oct 15, 2001
IPRATROPIUM BROMIDENEPHRONANDA 075562ANSep 27, 2001
IPRATROPIUM BROMIDEAPOTEX INCANDA 075441—Mar 28, 2001
IPRATROPIUM BROMIDERITEDOSE CORPANDA 075693ANJan 26, 2001
IPRATROPIUM BROMIDEZENNOVAANDA 075507—Jan 19, 2001
IPRATROPIUM BROMIDETEVA PHARMS USAANDA 075313—Feb 07, 2000
IPRATROPIUM BROMIDEACTAVIS MID ATLANTICANDA 075111—Apr 22, 1999
IPRATROPIUM BROMIDEPHARMOBEDIENTANDA 074755—Jan 10, 1997

Marketing exclusivity (1)

  • PCPatent-challenge (180-day generic) exclusivity

    Oct 13, 2026

    in 4 mo

Listed patents (1)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8474447Jan 17, 2030in 3 yr 8 mo
ProductDelisted

Ipratropium bromide — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

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