ALBUTEROL SULFATE - Generic Drug Details
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What are the generic 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, Padagis Us, Sandoz Inc, Teva Branded Pharm, Kindeva, Glaxosmithkline, Mylan Speciality Lp, Actavis Mid Atlantic, Akorn, Apotex Inc, Bausch And Lomb, Copley Pharm, Landela Pharm, Luoxin Aurovitas, 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, Rising, Muro, Strides Pharma, Am Therap, Amneal Pharms Co, Appco, Aurobindo Pharma Ltd, Eywa, Mylan, Pliva, Sun Pharm Industries, Ucb Inc, Virtus Pharm, Warner Chilcott, Zydus Pharms, Boehringer Ingelheim, Fosun Pharma, and Watson Labs Teva, and is included in ninety-nine NDAs. There are thirty-one 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-one patent family members in thirty-two countries.
There are eleven 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: | 451 |
US Patents: | 31 |
Tradenames: | 16 |
Applicants: | 50 |
NDAs: | 99 |
Drug Master File Entries: | 11 |
Finished Product Suppliers / Packagers: | 41 |
Raw Ingredient (Bulk) Api Vendors: | 70 |
Clinical Trials: | 43 |
Patent Applications: | 6,846 |
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 |
---|---|
Aurobindo Pharma Ltd | Phase 3 |
Wake Forest University Health Sciences | Early Phase 1 |
Teva Branded Pharmaceutical Products R&D, Inc. | Early Phase 1 |
Generic filers with tentative approvals for ALBUTEROL SULFATE
Applicant | Application No. | Strength | Dosage Form |
See Plans and Pricing | See Plans and Pricing | 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 | 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
Expired US Patents for ALBUTEROL SULFATE
International Patents for ALBUTEROL SULFATE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Australia | 2001270113 | See Plans and Pricing | |
Denmark | 1667627 | See Plans and Pricing | |
United Kingdom | 2365778 | Dose metering system for medicament inhaler | See Plans and Pricing |
Mexico | 339742 | CONTADORES DE DOSIS PARA INHALADORES, INHALADORES Y FLECHAS DE LOS MISMOS. (DOSE COUNTERS FOR INHALERS, INHALERS AND SHAFTS THEREOF.) | See Plans and Pricing |
Japan | 2010523184 | See Plans and Pricing | |
Spain | 2544278 | See Plans and Pricing | |
Cyprus | 1113531 | See Plans and Pricing | |
>Country | >Patent Number | >Title | >Estimated Expiration |
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