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 seventeen branded drugs marketed by Armstrong Pharms, Cipla, Lupin, Padagis Us, Sandoz, Teva Branded Pharm, Kindeva, Glaxosmithkline, Norvium Bioscience, Actavis Mid Atlantic, Apotex Inc, Bausch, Copley Pharm, Epic Pharma Llc, Landela Pharm, Lexenpharm, Luoxin Aurovitas, Nephron, Ritedose Corp, Roxane, Sentiss, Sun Pharm, Teva Pharms, Watson Labs, Watson Labs Inc, Wockhardt Eu Operatn, Schering, Amneal Pharms, Chartwell Molecular, Chartwell Rx, Cosette, Hikma, Mova, Quagen, Teva, Rising, Muro, Strides Pharma, Aizant, Am Therap, Amneal Pharms Co, Aurobindo Pharma Ltd, Dash Pharms Natco, Hibrow Hlthcare, Pliva, Sun Pharm Industries, Ucb Inc, Virtus Pharm, Warner Chilcott, Zydus Pharms, Astrazeneca, Boehringer Ingelheim, Aiping Pharm Inc, and Watson Labs Teva, and is included in one hundred and two NDAs. There are thirty-five patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Albuterol sulfate has three hundred and sixty-three patent family members in twenty-nine countries.
There are eleven drug master file entries for albuterol sulfate. Forty-five suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for albuterol sulfate
International Patents: | 363 |
US Patents: | 35 |
Tradenames: | 17 |
Applicants: | 54 |
NDAs: | 102 |
Drug Master File Entries: | 11 |
Finished Product Suppliers / Packagers: | 45 |
Raw Ingredient (Bulk) Api Vendors: | 81 |
Clinical Trials: | 46 |
Patent Applications: | 6,250 |
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 |
---|---|
Parexel | Phase 3 |
Bond Avillion 2 Development LP | Phase 3 |
Aurobindo Pharma Ltd | Phase 3 |
Generic filers with tentative approvals for ALBUTEROL SULFATE
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 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
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 | 072637-001 | Dec 5, 1989 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Aiping Pharm Inc | ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE | albuterol sulfate; ipratropium bromide | SOLUTION;INHALATION | 076867-001 | Dec 21, 2006 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Teva Branded Pharm | PROAIR HFA | albuterol sulfate | AEROSOL, METERED;INHALATION | 021457-001 | Oct 29, 2004 | AB2 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ 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 | |||
Astrazeneca | AIRSUPRA | albuterol sulfate; budesonide | AEROSOL, METERED;INHALATION | 214070-001 | Jan 10, 2023 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Teva | ALBUTEROL SULFATE | albuterol sulfate | TABLET;ORAL | 072620-001 | Dec 5, 1989 | 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 |
Expired US Patents for albuterol sulfate
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Glaxosmithkline | VENTOLIN HFA | albuterol sulfate | AEROSOL, METERED;INHALATION | 020983-001 | Apr 19, 2001 | ⤷ Sign Up | ⤷ Sign Up |
Schering | PROVENTIL | albuterol sulfate | SOLUTION;INHALATION | 019243-001 | Jan 14, 1987 | ⤷ Sign Up | ⤷ Sign Up |
Glaxosmithkline | VENTOLIN HFA | albuterol sulfate | AEROSOL, METERED;INHALATION | 020983-001 | Apr 19, 2001 | ⤷ Sign Up | ⤷ Sign Up |
Glaxosmithkline | VENTOLIN | albuterol sulfate | SYRUP;ORAL | 019621-001 | Jun 10, 1987 | ⤷ Sign Up | ⤷ Sign Up |
Kindeva | PROVENTIL-HFA | albuterol sulfate | AEROSOL, METERED;INHALATION | 020503-001 | Aug 15, 1996 | ⤷ Sign Up | ⤷ Sign Up |
Teva Branded Pharm | PROAIR RESPICLICK | albuterol sulfate | POWDER, METERED;INHALATION | 205636-001 | Mar 31, 2015 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for albuterol sulfate
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Israel | 223117 | מוני מינון למשאפים ומשאפים ועמודים למשאפים (Dose counters for inhalers and inhalers and shafts thereof) | ⤷ Sign Up |
Hong Kong | 1221920 | ⤷ Sign Up | |
World Intellectual Property Organization (WIPO) | 2021007154 | ⤷ Sign Up | |
Japan | 2016041380 | 吸入器のための用量カウンタ、吸入器及びそのシャフト (DOSE COUNTERS FOR INHALERS, INHALERS AND SHAFTS THEREOF) | ⤷ Sign Up |
Portugal | 1667627 | ⤷ Sign Up | |
San Marino | T201500026 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
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