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Generated: July 27, 2017
What are the generic sources for albuterol sulfate and what is the scope of albuterol sulfate patent protection?
Albuterol sulfate is the generic ingredient in fifteen branded drugs marketed by Mova, 3m Drug Delivery, Muro, Vintage, Copley Pharm, Glaxosmithkline, Pliva, Apotex Inc, Warner Chilcott, Teva, Ucb Inc, Roxane, Watson Labs, Dava Pharms Inc, Actavis Mid Atlantic, Teva Branded Pharm, Sun Pharm Inds, Ritedose Corp, Amneal Pharms, Hi Tech Pharma, Teva Pharms, Schering, Mylan Speciality Lp, Am Therap, Bausch And Lomb, Sandoz, Mylan Speclt, G And W Labs Inc, Nephron, Landela Pharm, Watson Labs Inc, Vistapharm, Mylan, Wockhardt Eu Operatn, Boehringer Ingelheim, Cipla Ltd, Watson Labs Teva, and Sandoz Inc, and is included in eighty-two NDAs. There are fifty-one patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.| Tradenames: | 15 |
| Patents: | 51 |
| Applicants: | 38 |
| NDAs: | 82 |
| Drug Master File Entries: see list | 37 |
| Suppliers / Packagers: see list | 41 |
| Bulk Api Vendors: see list | 135 |
| Clinical Trials: see list | 839 |
| Therapeutic Class: | Respiratory Tract Agents |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see low prices |
| DailyMed Link: | albuterol sulfate at DailyMed |
| Drug Class | beta2-Adrenergic Agonist |
| Mechanism of Action | Adrenergic beta2-Agonists |
| Applicant | Application No. | Strength | Dosage Form |
| ► Subscribe | ► Subscribe | EQ 0.083% BASE;0.017% | SOLUTION;INHALATION |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Schering | PROVENTIL | albuterol sulfate | TABLET;ORAL | 017853-001 | May 7, 1982 | DISCN | Yes | No | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
Sandoz Inc | ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE | albuterol sulfate; ipratropium bromide | SOLUTION;INHALATION | 076867-001 | Dec 21, 2006 | DISCN | No | No | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
Glaxosmithkline | VENTOLIN HFA | albuterol sulfate | AEROSOL, METERED;INHALATION | 020983-001 | Apr 19, 2001 | BX | RX | Yes | Yes | ► Subscribe | ► Subscribe | Y | ► Subscribe | ||||||||||||||||
Apotex Inc | ALBUTEROL SULFATE | albuterol sulfate | SOLUTION;INHALATION | 075717-001 | Feb 2, 2007 | DISCN | No | No | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
Schering | PROVENTIL | albuterol sulfate | SYRUP;ORAL | 018062-001 | Jan 19, 1983 | DISCN | Yes | No | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Schering | PROVENTIL | albuterol sulfate | TABLET;ORAL | 017853-001 | May 7, 1982 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Schering | PROVENTIL | albuterol sulfate | SYRUP;ORAL | 018062-001 | Jan 19, 1983 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Schering | PROVENTIL | albuterol sulfate | TABLET;ORAL | 017853-002 | May 7, 1982 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
3m Drug Delivery | PROVENTIL-HFA | albuterol sulfate | AEROSOL, METERED;INHALATION | 020503-001 | Aug 15, 1996 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Muro | VOLMAX | albuterol sulfate | TABLET, EXTENDED RELEASE;ORAL | 019604-001 | Dec 23, 1992 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
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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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 9,526,851 | Dose counters for inhalers, inhalers and methods of assembly thereof | ► Subscribe | |||||||||||||||||||||||||||
| 5,290,539 | Device for delivering an aerosol | ► Subscribe | |||||||||||||||||||||||||||
| 6,656,453 | Medicaments | ► Subscribe | |||||||||||||||||||||||||||
| 9,108,010 | Dose counters for inhalers, inhalers and methods of assembly thereof | ► Subscribe | |||||||||||||||||||||||||||
| 9,526,850 | Dose counters for inhalers, inhalers and methods of assembly thereof | ► 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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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Japan | 4794701 | ► Subscribe | |||||||||||||||||||||||||||
| South Korea | 20130101171 | ► Subscribe | |||||||||||||||||||||||||||
| China | 105903113 | ► Subscribe | |||||||||||||||||||||||||||
| United Kingdom | 0115519 | ► Subscribe | |||||||||||||||||||||||||||
| Hong Kong | 1219067 | ► 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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Serving 500+ biopharmaceutical companies globally:
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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