ALBUTEROL SULFATE Drug Patent 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 Armstrong Pharms, Cipla, Lupin, Padagis Us, Sandoz, Actavis Mid Atlantic, Apotex Inc, Bausch, Copley Pharm, Epic Pharma Llc, Landela Pharm, Lexenpharm, Luoxin Aurovitas, Nephron, Norvium Bioscience, Ritedose Corp, Roxane, Sentiss, Sun Pharm, Teva Pharms, Watson Labs, Watson Labs Inc, Wockhardt Eu Operatn, Amneal Pharms, Chartwell Molecular, Chartwell Rx, Cosette, Hikma, Mova, Quagen, Teva, Rising, Aizant, Am Therap, Amneal Pharms Co, Aurobindo Pharma Ltd, Dash Pharms Natco, Eywa, Pliva, Strides Pharma, Sun Pharm Industries, Ucb Inc, Virtus Pharm, Warner Chilcott, Zydus Pharms, Fosun Pharma, and Watson Labs Teva. and is included in eighty-two NDAs.
The generic ingredient in ALBUTEROL SULFATE is albuterol sulfate; ipratropium bromide. There are thirty-eight drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the albuterol sulfate; ipratropium bromide profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Albuterol Sulfate
A generic version of ALBUTEROL SULFATE was approved as albuterol sulfate; ipratropium bromide by CIPLA on December 31st, 2007.
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Summary for ALBUTEROL SULFATE
| US Patents: | 0 |
| Applicants: | 47 |
| NDAs: | 82 |
| Finished Product Suppliers / Packagers: | 40 |
| Raw Ingredient (Bulk) Api Vendors: | 81 |
| Clinical Trials: | 46 |
| Patent Applications: | 5,404 |
| Drug Prices: | Drug price information for ALBUTEROL SULFATE |
| Drug Sales Revenues: | Drug sales revenues for ALBUTEROL SULFATE |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ALBUTEROL SULFATE |
| What excipients (inactive ingredients) are in ALBUTEROL SULFATE? | ALBUTEROL SULFATE excipients list |
| DailyMed Link: | ALBUTEROL SULFATE at DailyMed |
See drug prices for ALBUTEROL SULFATE
Recent Clinical Trials for ALBUTEROL SULFATE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Bond Avillion 2 Development LP | Phase 3 |
| Parexel | Phase 3 |
| Aurobindo Pharma Ltd | 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 | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| PROVENTIL-HFA | Inhalation Aerosol | albuterol sulfate | 0.09 mg base per actuation | 020503 | 1 | 2015-05-20 |
| PROAIR HFA | Inhalation Aerosol | albuterol sulfate | 0.09 mg base per actuation | 021457 | 1 | 2012-05-18 |
| ACCUNEB | Inhalation Solution | albuterol sulfate | 0.021% | 020949 | 1 | 2005-10-19 |
| ACCUNEB | Inhalation Solution | albuterol sulfate | 0.042% | 020949 | 1 | 2004-04-06 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sun Pharm Industries | ALBUTEROL SULFATE | albuterol sulfate | TABLET;ORAL | 072637-002 | Dec 5, 1989 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Chartwell Rx | ALBUTEROL SULFATE | albuterol sulfate | SYRUP;ORAL | 077788-001 | Jun 26, 2007 | AA | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Sun Pharm | ALBUTEROL SULFATE | albuterol sulfate | SOLUTION;INHALATION | 207857-001 | Jul 21, 2017 | AN | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Watson Labs | ALBUTEROL SULFATE | albuterol sulfate | TABLET;ORAL | 072629-001 | Jan 31, 1991 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Rising | ALBUTEROL SULFATE | albuterol sulfate | TABLET, EXTENDED RELEASE;ORAL | 078092-001 | Jan 29, 2007 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
