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Last Updated: November 26, 2020

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Albuterol sulfate; ipratropium bromide - Generic Drug Details

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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, Apotex Inc, Aurobindo Pharma Ltd, Cipla, Fosun Pharma, Nephron, Ritedose Corp, Sun Pharm, Teva Pharms, Watson Labs Teva, and Mylan Speciality Lp, and is included in twelve NDAs. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Albuterol sulfate; ipratropium bromide has two hundred and thirty-five patent family members in forty-five countries.

There are thirty-eight drug master file entries for albuterol sulfate; ipratropium bromide. Twelve suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for albuterol sulfate; ipratropium bromide
International Patents:235
US Patents:9
Tradenames:4
Applicants:11
NDAs:12
Drug Master File Entries: 38
Suppliers / Packagers: 12
Clinical Trials: 4
DailyMed Link:albuterol sulfate; ipratropium bromide at DailyMed
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
  Start Trial  Start 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 NDA Submissiondate
DUONEB SOLUTION;INHALATION albuterol sulfate; ipratropium bromide 020950

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
Ritedose Corp ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE albuterol sulfate; ipratropium bromide SOLUTION;INHALATION 202496-001 Oct 1, 2012 AN RX No No   Start Trial   Start Trial   Start Trial
Teva Pharms ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE albuterol sulfate; ipratropium bromide SOLUTION;INHALATION 076724-001 Dec 31, 2007 DISCN No No   Start Trial   Start Trial   Start Trial
Boehringer Ingelheim COMBIVENT RESPIMAT albuterol sulfate; ipratropium bromide SPRAY, METERED;INHALATION 021747-001 Oct 7, 2011 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Boehringer Ingelheim COMBIVENT RESPIMAT albuterol sulfate; ipratropium bromide SPRAY, METERED;INHALATION 021747-001 Oct 7, 2011 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Fosun Pharma ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE albuterol sulfate; ipratropium bromide SOLUTION;INHALATION 076867-001 Dec 21, 2006 DISCN No No   Start Trial   Start Trial   Start Trial
Cipla ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE albuterol sulfate; ipratropium bromide SOLUTION;INHALATION 077559-001 Dec 31, 2007 AN RX No No   Start Trial   Start Trial   Start 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

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