Is there a generic for Ipratropium bromide?

Yes. The FDA Orange Book lists 28 approved generic (ANDA) applications for Ipratropium bromide, referencing the brand ATROVENT HFA. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Ipratropium bromide?

ATROVENT HFA (NDA 021527, BOEHRINGER INGELHEIM) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What patents protect Ipratropium bromide?

The Orange Book lists 1 patent against Ipratropium bromide products, with the earliest listed expiry in 2030. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

Does Ipratropium bromide have FDA marketing exclusivity?

Yes. The Orange Book records 1 marketing-exclusivity period for Ipratropium bromide. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

What dosage forms of Ipratropium bromide are approved?

Ipratropium bromide is approved in the following dosage forms: aerosol, metered, solution, spray, metered.

FDA Orange Book · active-ingredient family

Ipratropium bromide

Ipratropium bromide: 5 brands, 28 generics; first approved Dec 29, 1986; generic available.

Generic available1 exclusivity periodHas discontinued products

Generic status & protection

Generic available: 28 ANDA applications approved.

Earliest patent expiry Jan 17, 2030Latest exclusivity ends Oct 13, 2026

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Jan 17, 2030

in 3 yr 3 mo

Brand (NDA) products

Originator applications

Ask AI

ATROVENT HFARLDRS
BOEHRINGER INGELHEIMNDA 0215272004
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.021MG/INH AEROSOL, METERED INHALATION Rx AB
ATROVENTRLD
BOEHRINGER INGELHEIMNDA 0203931995
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.021MG/SPRAY SPRAY, METERED NASAL Discontinued -
ATROVENTRLD
BOEHRINGER INGELHEIMNDA 0203941995
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.042MG/SPRAY SPRAY, METERED NASAL Discontinued -
ATROVENTRLD
BOEHRINGER INGELHEIMNDA 0202281993
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.02% SOLUTION INHALATION Discontinued -
ATROVENT
BOEHRINGER INGELHEIMNDA 0190851986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.018MG/INH AEROSOL, METERED INHALATION Discontinued -

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.021MG/INH	AEROSOL, METERED	INHALATION	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.021MG/SPRAY	SPRAY, METERED	NASAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.042MG/SPRAY	SPRAY, METERED	NASAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.02%	SOLUTION	INHALATION	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.018MG/INH	AEROSOL, METERED	INHALATION	Discontinued	-

Generic (ANDA) products (28)

Abbreviated applications

Ask AI

IPRATROPIUM BROMIDE
ARMSTRONG PHARMSANDA 2179532026
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.021MG/INH AEROSOL, METERED INHALATION Rx AB
IPRATROPIUM BROMIDE
LUPINANDA 2179122025
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.021MG/SPRAY SPRAY, METERED NASAL Rx AB
IPRATROPIUM BROMIDE
LUPINANDA 2178862025
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.042MG/SPRAY SPRAY, METERED NASAL Rx AB
IPRATROPIUM BROMIDE
RUBICON RESEARCHANDA 2192222025
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.021MG/SPRAY SPRAY, METERED NASAL Rx AB
IPRATROPIUM BROMIDE
RUBICON RESEARCHANDA 2192212024
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.042MG/SPRAY SPRAY, METERED NASAL Rx AB
IPRATROPIUM BROMIDE
AMNEALANDA 2151042022
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.021MG/SPRAY SPRAY, METERED NASAL Rx AB
IPRATROPIUM BROMIDE
AMNEALANDA 2151052022
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.042MG/SPRAY SPRAY, METERED NASAL Rx AB
IPRATROPIUM BROMIDE
SUN PHARMANDA 2079032017
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.02% SOLUTION INHALATION Discontinued -
IPRATROPIUM BROMIDE
LUOXIN AUROVITASANDA 2065432016
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.02% SOLUTION INHALATION Rx AN
IPRATROPIUM BROMIDE
LANDELA PHARMANDA 0770722005
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.02% SOLUTION INHALATION Discontinued -
IPRATROPIUM BROMIDE
WATSON LABSANDA 0762912005
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.02% SOLUTION INHALATION Discontinued -
IPRATROPIUM BROMIDERS
HIKMAANDA 0766642003
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.021MG/SPRAY SPRAY, METERED NASAL Rx AB
IPRATROPIUM BROMIDERS
HIKMAANDA 0765982003
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.042MG/SPRAY SPRAY, METERED NASAL Rx AB
IPRATROPIUM BROMIDE
APOTEX INCANDA 0761562003
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.021MG/SPRAY SPRAY, METERED NASAL Rx AB
IPRATROPIUM BROMIDE
APOTEX INCANDA 0761552003
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.042MG/SPRAY SPRAY, METERED NASAL Rx AB
IPRATROPIUM BROMIDE
AUROBINDO PHARMA USAANDA 0755522003
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.021MG/SPRAY SPRAY, METERED NASAL Discontinued -
IPRATROPIUM BROMIDE
AUROBINDO PHARMA USAANDA 0755532003
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.042MG/SPRAY SPRAY, METERED NASAL Discontinued -
IPRATROPIUM BROMIDE
BAUSCHANDA 0760252003
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.021MG/SPRAY SPRAY, METERED NASAL Rx AB
IPRATROPIUM BROMIDE
BAUSCHANDA 0761032003
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.042MG/SPRAY SPRAY, METERED NASAL Rx AB
IPRATROPIUM BROMIDE
ROXANEANDA 0758672002
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.02% SOLUTION INHALATION Discontinued -
IPRATROPIUM BROMIDE
BAUSCHANDA 0758352001
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.02% SOLUTION INHALATION Discontinued -
IPRATROPIUM BROMIDE
NEPHRONANDA 0755622001
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.02% SOLUTION INHALATION Rx AN
IPRATROPIUM BROMIDE
APOTEX INCANDA 0754412001
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.02% SOLUTION INHALATION Discontinued -
IPRATROPIUM BROMIDERS
RITEDOSE CORPANDA 0756932001
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.02% SOLUTION INHALATION Rx AN
IPRATROPIUM BROMIDE
ZENNOVAANDA 0755072001
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.02% SOLUTION INHALATION Discontinued -
IPRATROPIUM BROMIDE
TEVA PHARMS USAANDA 0753132000
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.02% SOLUTION INHALATION Discontinued -
IPRATROPIUM BROMIDE
ACTAVIS MID ATLANTICANDA 0751111999
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.02% SOLUTION INHALATION Discontinued -
IPRATROPIUM BROMIDE
PHARMOBEDIENTANDA 0747551997
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.02% SOLUTION INHALATION Discontinued -

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.021MG/INH	AEROSOL, METERED	INHALATION	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.021MG/SPRAY	SPRAY, METERED	NASAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.042MG/SPRAY	SPRAY, METERED	NASAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.021MG/SPRAY	SPRAY, METERED	NASAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.042MG/SPRAY	SPRAY, METERED	NASAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.021MG/SPRAY	SPRAY, METERED	NASAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.042MG/SPRAY	SPRAY, METERED	NASAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.02%	SOLUTION	INHALATION	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.02%	SOLUTION	INHALATION	Rx	AN

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.02%	SOLUTION	INHALATION	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.02%	SOLUTION	INHALATION	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.021MG/SPRAY	SPRAY, METERED	NASAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.042MG/SPRAY	SPRAY, METERED	NASAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.021MG/SPRAY	SPRAY, METERED	NASAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.042MG/SPRAY	SPRAY, METERED	NASAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.021MG/SPRAY	SPRAY, METERED	NASAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.042MG/SPRAY	SPRAY, METERED	NASAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.021MG/SPRAY	SPRAY, METERED	NASAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.042MG/SPRAY	SPRAY, METERED	NASAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.02%	SOLUTION	INHALATION	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.02%	SOLUTION	INHALATION	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.02%	SOLUTION	INHALATION	Rx	AN

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.02%	SOLUTION	INHALATION	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.02%	SOLUTION	INHALATION	Rx	AN

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.02%	SOLUTION	INHALATION	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.02%	SOLUTION	INHALATION	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.02%	SOLUTION	INHALATION	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.02%	SOLUTION	INHALATION	Discontinued	-

Patent & exclusivity timeline

Protection horizon

Ask AI

Patent expiryExclusivity endToday

Marketing exclusivity

Hatch-Waxman

Ask AI

PCPatent-challenge (180-day generic) exclusivity
Oct 13, 2026
10 d ago

Listed patents

Orange Book patent file

Ask AI

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

Approval history

FDA approval span

Ask AI

First approval

Dec 29, 1986

40 yr 5 mo ago

Most recent approval

Feb 23, 2026

8 mo ago

Approvals span 1986–2026 across 33 FDA applications.

Brand (NDA) 515%

Generic (ANDA) 2885%

Ipratropium bromide: frequently asked questions

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

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Ask AI about Ipratropium bromide

Key facts