Albuterol - Generic Drug Details
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What are the generic sources for albuterol and what is the scope of freedom to operate?
Albuterol
is the generic ingredient in eighteen branded drugs marketed by Armstrong Pharms, Genpharm, Ivax Sub Teva Pharms, Pliva, Schering, Glaxosmithkline, Cipla, Lupin, Padagis Us, Sandoz, Teva Branded Pharm, Kindeva, 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, 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, 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 eight NDAs. There are thirty-five patents protecting this compound. Additional information is available in the individual branded drug profile pages.There are thirty-eight drug master file entries for albuterol. There is one tentative approval for this compound.
Summary for albuterol
US Patents: | 35 |
Tradenames: | 18 |
Applicants: | 56 |
NDAs: | 108 |
Drug Master File Entries: | 38 |
Raw Ingredient (Bulk) Api Vendors: | 133 |
Clinical Trials: | 287 |
Patent Applications: | 6,615 |
Drug Prices: | Drug price trends for albuterol |
Drug Sales Revenues: | Drug sales revenues for albuterol |
What excipients (inactive ingredients) are in albuterol? | albuterol excipients list |
DailyMed Link: | albuterol at DailyMed |
Recent Clinical Trials for albuterol
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Johns Hopkins University | Phase 3 |
Parexel | Phase 3 |
Norwegian School of Sport Sciences | N/A |
Generic filers with tentative approvals for ALBUTEROL
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.
Medical Subject Heading (MeSH) Categories for albuterol
US Patents and Regulatory Information for albuterol
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Pliva | ALBUTEROL SULFATE | albuterol sulfate | TABLET;ORAL | 072317-001 | Dec 5, 1989 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Schering | PROVENTIL | albuterol sulfate | TABLET;ORAL | 017853-002 | May 7, 1982 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Padagis Us | ALBUTEROL SULFATE | albuterol sulfate | AEROSOL, METERED;INHALATION | 203760-001 | Feb 24, 2020 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Norvium Bioscience | ALBUTEROL SULFATE | albuterol sulfate | SOLUTION;INHALATION | 072652-001 | Feb 21, 1992 | 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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Schering | PROVENTIL | albuterol | AEROSOL, METERED;INHALATION | 017559-001 | Approved Prior to Jan 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
Glaxosmithkline | VENTOLIN | albuterol | AEROSOL, METERED;INHALATION | 018473-001 | Approved Prior to Jan 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
Glaxosmithkline | VENTOLIN | albuterol | AEROSOL, METERED;INHALATION | 018473-001 | Approved Prior to Jan 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
Schering | PROVENTIL | albuterol | AEROSOL, METERED;INHALATION | 017559-001 | Approved Prior to Jan 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |