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Albuterol sulfate; ipratropium bromide - Generic Drug Details

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Albuterol sulfate; ipratropium bromide is the generic ingredient in four branded drugs marketed by Apotex Inc, Teva Pharms, Boehringer Ingelheim, Nephron, Mylan Speclt, Cipla Ltd, Watson Labs, Sandoz Inc, and Ritedose Corp, and is included in ten NDAs. There are nineteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has four hundred and ninety-one patent family members in forty-six countries.

There are thirty-five drug master file entries for albuterol sulfate; ipratropium bromide. Fourteen suppliers are listed for this compound.

Summary for Generic Name: albuterol sulfate; ipratropium bromide

Tradenames:4
Patents:19
Applicants:9
NDAs:10
Drug Master File Entries: see list35
Suppliers / Packaging: see list14
Formulation / Manufacturing:see details

Pharmacology for Ingredient: albuterol sulfate; ipratropium bromide

Clinical Trials for: albuterol sulfate; ipratropium bromide

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Watson Labs
ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE
albuterol sulfate; ipratropium bromide
SOLUTION;INHALATION077063-001Dec 31, 2007RXNo<disabled><disabled>
Boehringer Ingelheim
COMBIVENT RESPIMAT
albuterol sulfate; ipratropium bromide
SPRAY, METERED;INHALATION021747-001Oct 7, 2011RXYes6,846,413<disabled>Y <disabled>
Boehringer Ingelheim
COMBIVENT RESPIMAT
albuterol sulfate; ipratropium bromide
SPRAY, METERED;INHALATION021747-001Oct 7, 2011RXYes7,104,470<disabled>Y <disabled>
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Expired Orange Book Patents for Generic Ingredient: albuterol sulfate; ipratropium bromide

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Boehringer Ingelheim
COMBIVENT RESPIMAT
albuterol sulfate; ipratropium bromide
SPRAY, METERED;INHALATION021747-001Oct 7, 20115,662,271<disabled>
Boehringer Ingelheim
COMBIVENT RESPIMAT
albuterol sulfate; ipratropium bromide
SPRAY, METERED;INHALATION021747-001Oct 7, 20116,007,676<disabled>
Boehringer Ingelheim
COMBIVENT
albuterol sulfate; ipratropium bromide
AEROSOL, METERED;INHALATION020291-001Oct 24, 19965,603,918<disabled>
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Non-Orange Book Patents for Generic Ingredient: 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
5,472,143 Atomising nozzle and filter and spray generation device<disabled in preview>
6,007,676 Atomizing nozzle and filter and spray generating device<disabled in preview>
5,911,851 Atomizing nozzle and filter and spray generating device<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: albuterol sulfate; ipratropium bromide

Country Document Number Estimated Expiration
Slovakia89098<disabled in preview>
Estonia200100439<disabled in preview>
Hungary9900741<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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