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Generated: August 20, 2018

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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 albuterol sulfate; ipratropium bromide freedom to operate?

Albuterol sulfate; ipratropium bromide is the generic ingredient in four branded drugs marketed by Boehringer Ingelheim, Apotex Inc, Cipla Ltd, Fosun Pharma, Nephron, Ritedose Corp, Sun Pharma Global, Teva Pharms, Watson Labs Teva, and Mylan Speciality Lp, and is included in eleven NDAs. There are twelve patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

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

Summary for ALBUTEROL SULFATE; IPRATROPIUM BROMIDE
International Patents:291
US Patents:12
Tradenames:4
Applicants:10
NDAs:11
Drug Master File Entries: 38
Suppliers / Packagers: 16
Clinical Trials: 4
DailyMed Link:ALBUTEROL SULFATE; IPRATROPIUM BROMIDE at DailyMed
Pharmacology for ALBUTEROL SULFATE; IPRATROPIUM BROMIDE
Tentative approvals for ALBUTEROL SULFATE; IPRATROPIUM BROMIDE
Applicant Application No. Strength Dosage Form
➤ Sign Up➤ Sign UpEQ 0.083% BASE;0.017%SOLUTION;INHALATION

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
Mylan Speciality Lp DUONEB albuterol sulfate; ipratropium bromide SOLUTION;INHALATION 020950-001 Mar 21, 2001 DISCN Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Boehringer Ingelheim COMBIVENT RESPIMAT albuterol sulfate; ipratropium bromide SPRAY, METERED;INHALATION 021747-001 Oct 7, 2011 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Boehringer Ingelheim COMBIVENT RESPIMAT albuterol sulfate; ipratropium bromide SPRAY, METERED;INHALATION 021747-001 Oct 7, 2011 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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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
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for ALBUTEROL SULFATE; IPRATROPIUM BROMIDE

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,084,461 Albuterol and ipratropium inhalation solution, system, kit and method for relieving symptoms of chronic obstructive pulmonary disease ➤ Sign Up
6,503,440 Process for making a container with a pressure equalization opening and containers produced accordingly ➤ Sign Up
7,451,884 Container provided with a pressure equalization opening ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
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Julphar
Federal Trade Commission
Cantor Fitzgerald
US Department of Justice
Moodys
Baxter
Healthtrust

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