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Last Updated: March 28, 2024

Albuterol sulfate; ipratropium bromide - Generic Drug Details


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What are the generic sources for albuterol sulfate; ipratropium bromide and what is the scope of patent protection?

Albuterol sulfate; ipratropium bromide is the generic ingredient in four branded drugs marketed by Boehringer Ingelheim, Apotex Inc, Cipla, Fosun Pharma, Luoxin Aurovitas, Nephron, Ritedose Corp, Sun Pharm, Teva Pharms, Watson Labs Teva, and Mylan Speciality Lp, 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
⤷  Try a Trial⤷  Try a TrialEQ 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
Nephron ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE albuterol sulfate; ipratropium bromide SOLUTION;INHALATION 076749-001 Dec 31, 2007 AN RX No Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Cipla ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE albuterol sulfate; ipratropium bromide SOLUTION;INHALATION 077559-001 Dec 31, 2007 AN RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Apotex Inc ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE albuterol sulfate; ipratropium bromide SOLUTION;INHALATION 077117-001 Dec 31, 2007 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Luoxin Aurovitas ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE albuterol sulfate; ipratropium bromide SOLUTION;INHALATION 206532-001 Jul 8, 2020 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sun Pharm ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE albuterol sulfate; ipratropium bromide SOLUTION;INHALATION 207875-001 Aug 7, 2017 AN RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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

International Patents for albuterol sulfate; ipratropium bromide

Country Patent Number Title Estimated Expiration
Eurasian Patent Organization 008027 МИКРОСТРУКТУРИРОВАННАЯ СОПЛОВАЯ ГОЛОВКА ВЫСОКОГО ДАВЛЕНИЯ С ИНТЕГРИРОВАННОЙ ФИЛЬТРУЮЩЕЙ ФУНКЦИЕЙ (MICROSTRUCTURED HIGH PRESSURE NOZZLE WITH AN IN-BUILT FILTER FUNCTION) ⤷  Try a Trial
Hong Kong 1084909 Blocking device for a sprung lock with a spring operation ⤷  Try a Trial
Austria 485891 ⤷  Try a Trial
Denmark 1539368 ⤷  Try a Trial
Denmark 1641569 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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