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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-six drug master file entries for albuterol sulfate; ipratropium bromide. Fifteen 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 list36
Suppliers / Packaging: see list15
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: albuterol sulfate; ipratropium bromide

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Boehringer Ingelheim
COMBIVENT RESPIMAT
albuterol sulfate; ipratropium bromide
SPRAY, METERED;INHALATION021747-001Oct 7, 2011RXYes7,802,568► subscribeY ► subscribe
Cipla Ltd
ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE
albuterol sulfate; ipratropium bromide
SOLUTION;INHALATION077559-001Dec 31, 2007RXNo► subscribe► subscribe
Boehringer Ingelheim
COMBIVENT RESPIMAT
albuterol sulfate; ipratropium bromide
SPRAY, METERED;INHALATION021747-001Oct 7, 2011RXYes6,149,054► subscribeY ► subscribe
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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, 20115,497,944► subscribe
Boehringer Ingelheim
COMBIVENT RESPIMAT
albuterol sulfate; ipratropium bromide
SPRAY, METERED;INHALATION021747-001Oct 7, 20117,246,615► subscribe
Boehringer Ingelheim
COMBIVENT
albuterol sulfate; ipratropium bromide
AEROSOL, METERED;INHALATION020291-001Oct 24, 19965,603,918► subscribe
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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
5,547,094 Method for producing atomizing nozzle assemblies► subscribe
6,402,055 Device for producing high pressure in a fluid in miniature► subscribe
6,007,676 Atomizing nozzle and filter and spray generating device► subscribe
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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
Japan2010138913► subscribe
Canada2473681► subscribe
Germany4236037► subscribe
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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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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