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ALBUTEROL SULFATE Drug Profile
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Which patents cover Albuterol Sulfate, and when can generic versions of Albuterol Sulfate launch?
Albuterol Sulfate is a drug marketed by Cipla, Lupin, Perrigo Pharms Co, Actavis Mid Atlantic, Akorn, Apotex Inc, Aurobindo Pharma Ltd, Bausch And Lomb, Copley Pharm, Landela Pharm, Mylan Speclt, Nephron, Ritedose Corp, Roxane, Sun Pharm, Teva Pharms, Watson Labs, Watson Labs Inc, Wockhardt Eu Operatn, Amneal Pharms, Chartwell Rx, Cosette, Lannett Co Inc, Mova, Quagen, Teva, Mylan, Aizant, Am Therap, Amneal Pharms Co, Dava Pharms Inc, Eywa, Pliva, Rising, Sun Pharm Industries, Ucb Inc, Virtus Pharm, Warner Chilcott, Yaopharma Co Ltd, Zydus Pharms, Fosun Pharma, and Watson Labs Teva. and is included in seventy-nine NDAs.
The generic ingredient in ALBUTEROL SULFATE is albuterol sulfate; ipratropium bromide. There are thirty-eight drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the albuterol sulfate; ipratropium bromide profile page.
Summary for ALBUTEROL SULFATE
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Recent Clinical Trials for ALBUTEROL SULFATE
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| Sponsor | Phase |
|---|---|
| University of California, Irvine | Phase 4 |
| Sun Pharmaceutical Industries Limited | Phase 3 |
| Amneal Ireland Limited | Phase 3 |
Pharmacology for ALBUTEROL SULFATE
| Drug Class | beta2-Adrenergic Agonist |
| Mechanism of Action | Adrenergic beta2-Agonists |
Paragraph IV (Patent) Challenges for ALBUTEROL SULFATE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| PROVENTIL-HFA | AEROSOL, METERED;INHALATION | albuterol sulfate | 020503 | 2015-05-20 |
| PROAIR HFA | AEROSOL, METERED;INHALATION | albuterol sulfate | 021457 | 2012-05-18 |
| ACCUNEB | SOLUTION;INHALATION | albuterol sulfate | 020949 | 2005-10-19 |
| VENTOLIN | SYRUP;ORAL | albuterol sulfate | 019621 | |
| VOLMAX | TABLET, EXTENDED RELEASE;ORAL | albuterol sulfate | 019604 |
US Patents and Regulatory Information for ALBUTEROL SULFATE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Ucb Inc | ALBUTEROL SULFATE | albuterol sulfate | TABLET;ORAL | 073120-001 | Sep 29, 1992 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Watson Labs | ALBUTEROL SULFATE | albuterol sulfate | SYRUP;ORAL | 073165-001 | Apr 29, 1993 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Actavis Mid Atlantic | ALBUTEROL SULFATE | albuterol sulfate | SYRUP;ORAL | 075262-001 | Mar 30, 1999 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
