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Albuterol sulfate - Generic Drug Details
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This ingredient has three hundred and sixty-three patent family members in forty-two countries.
There are thirty-five drug master file entries for albuterol sulfate. Forty-three suppliers are listed for this compound.
Summary for Generic Name: albuterol sulfate
| Tradenames: | 15 |
| Patents: | 52 |
| Applicants: | 36 |
| NDAs: | 83 |
| Drug Master File Entries: see list | 35 |
| Suppliers / Packaging: see list | 43 |
| Therapeutic Class: | Respiratory Tract Agents |
| Drug Prices: | see low prices |
Pharmacology for Ingredient: albuterol sulfate
| Drug Class | beta2-Adrenergic Agonist |
| Mechanism of Action | Adrenergic beta2-Agonists |
Clinical Trials for: albuterol sulfate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Type | RLD | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Nephron | ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE | albuterol sulfate; ipratropium bromide | SOLUTION;INHALATION | 076749-001 | Dec 31, 2007 | RX | No | ||||||||||||||||||||||
Dava Pharms Inc | ALBUTEROL SULFATE | albuterol sulfate | TABLET;ORAL | 072860-001 | Dec 20, 1989 | DISCN | No | ||||||||||||||||||||||
Glaxosmithkline | VENTOLIN HFA | albuterol sulfate | AEROSOL, METERED;INHALATION | 020983-001 | Apr 19, 2001 | RX | Yes | 6,997,349*PED | Jul 16, 2018 | Y | |||||||||||||||||||
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Expired Orange Book Patents for Generic Ingredient: albuterol sulfate
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Glaxosmithkline | VENTOLIN | albuterol sulfate | TABLET;ORAL | 019112-001 | Jul 10, 1986 | 3,705,233 | <disabled> | ||||||||||||||||||||||
Glaxosmithkline | VENTOLIN HFA | albuterol sulfate | AEROSOL, METERED;INHALATION | 020983-001 | Apr 19, 2001 | 6,596,260*PED | <disabled> | ||||||||||||||||||||||
Schering | PROVENTIL | albuterol sulfate | SYRUP;ORAL | 018062-001 | Jan 19, 1983 | 3,705,233 | <disabled> | ||||||||||||||||||||||
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Non-Orange Book Patents for Generic Ingredient: albuterol sulfate
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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 7,101,534 | Suspension aerosol formulations | <disabled in preview> | |||||||||||||||||||||||||||
| 9,108,010 | Dose counters for inhalers, inhalers and methods of assembly thereof | <disabled in preview> | |||||||||||||||||||||||||||
| 9,174,013 | Dose counters for inhalers, inhalers and methods of assembly thereof | <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
| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Spain | 2520966 | <disabled in preview> | |||||||||||||||||||||||||||
| Denmark | 1415934 | <disabled in preview> | |||||||||||||||||||||||||||
| Portugal | 2502644 | <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.
Export unavailable in trial.
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How are People Using DrugPatentWatch?
To know about the patents in my country
— Sales and marketing chief, pharmaceutical importing, Colombia
To find patent expirations in Russia
— Pharmaceutical company, Russia
To identify APIs going off-patent in the next few years
— API manufacturer, India
To review IP for certain products that are set to expire shortly
— Senior vice president, pharmaceutical wholesaler, Canada
information on patent expiries and potential generic entrants
— Consultant, USA
To get the patent status of key drugs
— Marketing manager, Chile
For paragraph IV challenge research
— Pharmaceutical company, USA
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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