You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: November 21, 2024

Albuterol sulfate; ipratropium bromide - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


What are the generic drug sources for albuterol sulfate; ipratropium bromide and what is the scope of freedom to operate?

Albuterol sulfate; ipratropium bromide is the generic ingredient in four branded drugs marketed by Boehringer Ingelheim, Aiping Pharm Inc, Apotex Inc, Cipla, Luoxin Aurovitas, Nephron, Ritedose Corp, Sun Pharm, Teva Pharms, Watson Labs Teva, and Norvium Bioscience, and is included in twelve NDAs. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Albuterol sulfate; ipratropium bromide has one hundred and eighteen patent family members in thirty-six countries.

Fifteen suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for albuterol sulfate; ipratropium bromide
Recent Clinical Trials for albuterol sulfate; ipratropium bromide

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
James J. Peters Veterans Affairs Medical CenterPhase 2
University of Texas Southwestern Medical CenterPhase 4
DeyPhase 3

See all albuterol sulfate; ipratropium bromide clinical trials

Generic filers with tentative approvals for ALBUTEROL SULFATE; IPRATROPIUM BROMIDE
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign UpEQ 0.083% BASE;0.017%SOLUTION;INHALATION

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for albuterol sulfate; ipratropium bromide
Paragraph IV (Patent) Challenges for ALBUTEROL SULFATE; IPRATROPIUM BROMIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
COMBIVENT RESPIMAT Inhalation Aerosol albuterol sulfate; ipratropium bromide 100 mcg/20 mcg per actuation 021747 1 2023-03-30

US Patents and Regulatory Information for albuterol sulfate; ipratropium bromide

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Watson Labs Teva ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE albuterol sulfate; ipratropium bromide SOLUTION;INHALATION 077063-001 Dec 31, 2007 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Teva Pharms ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE albuterol sulfate; ipratropium bromide SOLUTION;INHALATION 076724-001 Dec 31, 2007 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Nephron ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE albuterol sulfate; ipratropium bromide SOLUTION;INHALATION 076749-001 Dec 31, 2007 AN RX No Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sun Pharm ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE albuterol sulfate; ipratropium bromide SOLUTION;INHALATION 207875-001 Aug 7, 2017 AN RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for albuterol sulfate; ipratropium bromide

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Boehringer Ingelheim COMBIVENT RESPIMAT albuterol sulfate; ipratropium bromide SPRAY, METERED;INHALATION 021747-001 Oct 7, 2011 ⤷  Sign Up ⤷  Sign Up
Boehringer Ingelheim COMBIVENT RESPIMAT albuterol sulfate; ipratropium bromide SPRAY, METERED;INHALATION 021747-001 Oct 7, 2011 ⤷  Sign Up ⤷  Sign Up
Boehringer Ingelheim COMBIVENT RESPIMAT albuterol sulfate; ipratropium bromide SPRAY, METERED;INHALATION 021747-001 Oct 7, 2011 ⤷  Sign Up ⤷  Sign Up
Boehringer Ingelheim COMBIVENT albuterol sulfate; ipratropium bromide AEROSOL, METERED;INHALATION 020291-001 Oct 24, 1996 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for albuterol sulfate; ipratropium bromide

Country Patent Number Title Estimated Expiration
World Intellectual Property Organization (WIPO) 2004053362 ⤷  Sign Up
Serbia 50551 SREDSTVO ZA DRŽANJE FLUIDNE KOMPONENTE (DEVICE FOR HOLDING A FLUIDIC COMPONENT) ⤷  Sign Up
Japan 5046215 ⤷  Sign Up
Taiwan 200418541 Blocking device for a locking-stressing-mechanism having a spring-actuated output drive device ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.