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Last Updated: March 18, 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 freedom to operate?

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
Boehringer Ingelheim COMBIVENT RESPIMAT albuterol sulfate; ipratropium bromide SPRAY, METERED;INHALATION 021747-001 Oct 7, 2011 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Mylan Speciality Lp DUONEB albuterol sulfate; ipratropium bromide SOLUTION;INHALATION 020950-001 Mar 21, 2001 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Boehringer Ingelheim COMBIVENT RESPIMAT albuterol sulfate; ipratropium bromide SPRAY, METERED;INHALATION 021747-001 Oct 7, 2011 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Fosun Pharma ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE albuterol sulfate; ipratropium bromide SOLUTION;INHALATION 076867-001 Dec 21, 2006 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Boehringer Ingelheim COMBIVENT RESPIMAT albuterol sulfate; ipratropium bromide SPRAY, METERED;INHALATION 021747-001 Oct 7, 2011 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  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
Cyprus 1107900 ⤷  Try a Trial
Mexico PA05013878 BOQUILLA MICROESTRUCTURADA DE ALTA PRESION CON FUNCION DE FILTRO INCORPORADA. (MICROSTRUCTURED HIGH PRESSURE NOZZLE WITH AN IN-BUILT FILTER FUNCTION.) ⤷  Try a Trial
Colombia 5720979 DISPOSITIVO BLOQUEADOR PARA UN MECANISMO TENSOR DE BLOQUEO CON UNA TOMA DE FUERZA ACCIONADA POR RESORTE ⤷  Try a Trial
Argentina 041060 DISPOSITIVO BLOQUEADOR PARA UN MECANISMO TENSOR DE BLOQUEO CON UNA TOMA DE FUERZA ACCIONADA POR RESORTE ⤷  Try a Trial
Japan 4411209 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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