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Albuterol sulfate - Generic Drug Details
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What are the generic drug sources for albuterol sulfate and what is the scope of patent protection?
Albuterol sulfate
is the generic ingredient in sixteen branded drugs marketed by Cipla, Lupin, Perrigo Pharms Co, Teva Branded Pharm, Kindeva, Glaxosmithkline, Mylan Speciality Lp, 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, Schering, Amneal Pharms, Chartwell Rx, Cosette, Lannett Co Inc, Mova, Quagen, Teva, Mylan, Muro, Dava Pharms Inc, Aizant, Am Therap, Amneal Pharms Co, Eywa, Pliva, Rising, Sun Pharm Industries, Ucb Inc, Virtus Pharm, Warner Chilcott, Yaopharma Co Ltd, Zydus Pharms, Boehringer Ingelheim, Fosun Pharma, and Watson Labs Teva, and is included in ninety-eight NDAs. There are thirty-eight patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Albuterol sulfate has four hundred and fifty-seven patent family members in thirty-two countries.
There are thirty-eight drug master file entries for albuterol sulfate. Forty-one suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for albuterol sulfate
| International Patents: | 457 |
| US Patents: | 38 |
| Tradenames: | 16 |
| Applicants: | 49 |
| NDAs: | 98 |
| Drug Master File Entries: | 38 |
| Suppliers / Packagers: | 41 |
| Bulk Api Vendors: | 60 |
| Clinical Trials: | 27 |
| Patent Applications: | 6,121 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price trends 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 |
Recent Clinical Trials for albuterol sulfate
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of California, Irvine | Phase 4 |
| Sun Pharmaceutical Industries Limited | Phase 3 |
| Amneal Ireland Limited | Phase 3 |
Generic filers with tentative approvals for ALBUTEROL SULFATE
| Applicant | Application No. | Strength | Dosage Form |
| Start Trial | Start Trial | EQ 0.083% BASE;0.017% | SOLUTION;INHALATION |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
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 |
| VOLMAX | TABLET, EXTENDED RELEASE;ORAL | albuterol sulfate | 019604 | |
| VENTOLIN | SYRUP;ORAL | albuterol sulfate | 019621 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mylan | ALBUTEROL SULFATE | albuterol sulfate | TABLET, EXTENDED RELEASE;ORAL | 078092-002 | Jan 29, 2007 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Teva Branded Pharm | PROAIR DIGIHALER | albuterol sulfate | POWDER, METERED;INHALATION | 205636-002 | Dec 21, 2018 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Ucb Inc | ALBUTEROL SULFATE | albuterol sulfate | TABLET;ORAL | 073121-001 | Sep 29, 1992 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Teva Branded Pharm | PROAIR DIGIHALER | albuterol sulfate | POWDER, METERED;INHALATION | 205636-002 | Dec 21, 2018 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for albuterol sulfate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Schering | PROVENTIL | albuterol sulfate | SOLUTION;INHALATION | 019243-002 | Jan 14, 1987 | Start Trial | Start Trial |
| Glaxosmithkline | VENTOLIN HFA | albuterol sulfate | AEROSOL, METERED;INHALATION | 020983-001 | Apr 19, 2001 | Start Trial | Start Trial |
| Glaxosmithkline | VENTOLIN HFA | albuterol sulfate | AEROSOL, METERED;INHALATION | 020983-001 | Apr 19, 2001 | Start Trial | Start Trial |
| Glaxosmithkline | VENTOLIN | albuterol sulfate | TABLET;ORAL | 019112-002 | Jul 10, 1986 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for albuterol sulfate
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Mexico | 2017002552 | Start Trial |
| Japan | 3908269 | Start Trial |
| Spain | 2544277 | Start Trial |
| China | 105903108 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
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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 verification 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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