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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 albuterol sulfate freedom to operate?
Albuterol sulfate
is the generic ingredient in sixteen branded drugs marketed by Teva Branded Pharm, 3m Drug Delivery, Glaxosmithkline, Mylan Speciality Lp, Actavis Mid Atlantic, Apotex Inc, Aurobindo Pharma Ltd, Bausch And Lomb, Copley Pharm, Hi Tech Pharma, Landela Pharm, Mylan Speclt, Nephron, Ritedose Corp, Roxane, Sun Pharm, Teva Pharms, Watson Labs, Watson Labs Inc, Wockhardt Eu Operatn, Schering, Amneal Pharms, G And W Labs Inc, Lannett Co Inc, Mova, Teva, Vistapharm, Mylan, Muro, Dava Pharms Inc, Aizant, Am Therap, Amneal Pharms Co, Appco Pharma Llc, Pliva, Sun Pharm Industries, Ucb Inc, Virtus Pharm, Warner Chilcott, Yaopharma Co Ltd, Boehringer Ingelheim, Cipla, Fosun Pharma, and Watson Labs Teva, and is included in eighty-nine NDAs. There are thirty-six 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 ninety-nine patent family members in forty-two countries.
There are thirty-eight drug master file entries for albuterol sulfate. Fifty suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for ALBUTEROL SULFATE
| International Patents: | 499 |
| US Patents: | 36 |
| Tradenames: | 16 |
| Applicants: | 44 |
| NDAs: | 89 |
| Drug Master File Entries: | 38 |
| Suppliers / Packagers: | 50 |
| Bulk Api Vendors: | 95 |
| Clinical Trials: | 26 |
| Patent Applications: | 6,000 |
| 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 |
| DailyMed Link: | ALBUTEROL SULFATE at DailyMed |
Pharmacology for ALBUTEROL SULFATE
| Drug Class | beta2-Adrenergic Agonist |
| Mechanism of Action | Adrenergic beta2-Agonists |
Synonyms for ALBUTEROL SULFATE
| .alpha.1-[(tert-Butylamino)methyl]-4-hydroxy-m-xylene-.alpha.,.alpha.'-diol sulfate (2:1) salt |
| (+-)-Salbutamol sulfate |
| (+-)-ysulfate(2:1)(salt) |
| (C13H21NO3)2.H2SO4 |
| 022S709 |
| 1-(4-Hydroxy-3-hydroxymethylphenyl)-2-(tert-butylamino)ethanol sulfate |
| 1, .alpha.1-[[(1,1-dimethylethyl)amino]methyl]-4-hydroxy-, sulfate (2:1) (salt) |
| 1, .alpha.1-[[(1,1-dimethylethyl)amino]methyl]-4-hydroxy-, sulfate (2:1) salt |
| 1,3-Benzenedimethanol, alpha(sup 1)-(((1,1-dimethylethyl)amino)methyl)-4-hydroxy-, sulfate (2:1) (salt) |
| 1,3-Benzenedimethanol, alpha(sup 1)-(((1,1-dimethylethyl)amino)methyl)-4-hydroxy-,sulfate (2:1) (salt) |
| 1,3-Benzenedimethanol, alpha1-(((1,1-dimethylethyl)amino)methyl)-4-hydroxy-, sulfate (2:1) (salt) |
| 2-(tert-Butylamino)-1-(4-hydroxy-3-hydroxymethylphenyl)ethanol Hemisulfate |
| 2200AH |
| 34245-12-0 |
| 36519-31-0 |
| 39971-61-4 |
| 4-(2-(tert-butylamino)-1-hydroxyethyl)-2-(hydroxymethyl)phenol hemisulfate |
| 4-(2-(tert-Butylamino)-1-hydroxyethyl)-2-(hydroxymethyl)phenol sulfate |
| 4-[2-(tert-butylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol; sulfuric acid |
| 4-[2-(tert-butylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol;sulfuric acid |
| 5-[2-(tert-Butylamino)-1-hydroxyethyl]-2-hydroxybenzyl Alcohol Hemisulfate |
| 51022-70-9 |
| AB0013333 |
| AB1009413 |
| AC-6369 |
| AC1L22LX |
| AccuNeb |
| Accuneb (TN) |
| Accuvent |
| Aerolin |
| Aerotec |
| AH-3365 |
| AKOS015951296 |
| AKOS015994719 |
| Albuterol hemisulfate |
| Albuterol sulfate (USP) |
| Albuterol sulfate [USAN:USP] |
| Albuterol sulfate [USAN] |
| Albuterol sulfate, Pharmaceutical Secondary Standard; Certified Reference Material |
| Albuterol sulfate, United States Pharmacopeia (USP) Reference Standard |
| Albuterol Sulfate,(S) |
| Albuterol sulfate(1:x) |
| Albuterol sulfate(2:1) |
| Aloprol |
| alpha-([t-Butylamino]methyl)-4-hydroxy-m-xylene-alpha,alpha'-diol |
| alpha(sup 1)-((tert-Butylamino)methyl)-4-hydroxy-m-xylene-alpha,alpha'-diol sulfate (2:1) (salt) |
| Amocasin |
| API0004123 |
| Asmaven sulfate |
| Asthalin |
| Asthavent |
| AX8292143 |
| BCP02974 |
| BCP0726000244 |
| BG0312 |
| Bis((tert-butyl)(beta,3,4-trihydroxyphenethyl)ammonium) sulphate |
| bis(salbutamol); sulfuric acid |
| Broncho Inhalat |
| Bronchospray |
| Broncodil |
| Buventol Easyhaler |
| C13H21NO3??1/2H2SO4 |
| C13H21NO3.H2O4S |
| CA0122 |
| CCG-100775 |
| CCG-222402 |
| CHEBI:2550 |
| CHEMBL1201026 |
| CHEMBL1441059 |
| CPD000058513 |
| CTK4J3501 |
| D00683 |
| Dipulmin |
| dl-Salbutamol sulfate |
| Eae -Ae |
| EINECS 256-916-8 |
| Emican |
| Epaq |
| EU-0101098 |
| Fartolin |
| FT-0650809 |
| H886 |
| HMS2051A09 |
| HMS3263K18 |
| HMS3266D17 |
| HMS3393A09 |
| Huma-Salmol |
| Inspiryl |
| J10322 |
| K-9412 |
| KS-00000RSS |
| KS-5056 |
| KSC593K0D |
| Loftan |
| LP01098 |
| LS-162604 |
| LS-29862 |
| MFCD00055200 |
| MLS000758199 |
| MLS001423971 |
| MolPort-003-933-916 |
| MolPort-005-933-644 |
| NC00025 |
| NCGC00094370-01 |
| NCGC00261783-01 |
| NSC 289928 |
| NSC-289928 |
| NSC289928 |
| OVICLFZZVQVVFT-UHFFFAOYSA-N |
| Pediavent |
| ProAir |
| Proair HFA |
| Proair Respiclick |
| Proventil (TN) |
| Proventil Repetabs |
| Proventil Repetabs, Solution, Syrup, and Tablets |
| Proventil-HFA |
| Pulvinal salbutamol |
| S 5013 |
| S0531 |
| s2507 |
| Salbutamol Diskus |
| Salbutamol Easyhaler |
| Salbutamol hemisulfate |
| Salbutamol hemisulfate salt |
| Salbutamol hemisulfate salt, >=98% |
| Salbutamol hemisulfate salt, VETRANAL(TM), analytical standard |
| Salbutamol hemisulfate, 98% |
| Salbutamol hemisulphate |
| Salbutamol hemisulphate salt |
| Salbutamol sulfate |
| Salbutamol sulfate - Albuterol |
| Salbutamol sulfate (Albuterol) |
| Salbutamol sulfate (JP17) |
| Salbutamol sulfate for system suitability, European Pharmacopoeia (EP) Reference Standard |
| Salbutamol sulfate, British Pharmacopoeia (BP) Reference Standard |
| Salbutamol sulfate, European Pharmacopoeia (EP) Reference Standard |
| Salbutamol sulfate(Albuterol) |
| salbutamol sulphate (albuterol sulphate) |
| Salbutamol Sulphate (Albuterol Sulphate) 1.0 mg/ml in Methanol (as free base) |
| salbutamol; sulfuric acid |
| SAM001246971 |
| SC-18559 |
| Sch 13949W sulfate |
| SCH-13949W |
| SCH-13949W Sulfate |
| SCHEMBL33279 |
| SCHEMBL33280 |
| SMR000058513 |
| Sulbutamol sulphate |
| TBS-7 |
| TL8003382 |
| Tox21_501098 |
| TQ-1016 |
| Venetlin |
| Ventolin |
| Ventolin (TN) |
| Ventolin easy-breathe |
| Ventolin HFA |
| Ventolin Nebules |
| Ventorlin |
| Volare |
| VoSpire ER |
Generic filers with tentative approvals for ALBUTEROL SULFATE
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Muro | VOLMAX | albuterol sulfate | TABLET, EXTENDED RELEASE;ORAL | 019604-001 | Dec 23, 1992 | DISCN | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Ritedose Corp | ALBUTEROL SULFATE | albuterol sulfate | SOLUTION;INHALATION | 077839-001 | Dec 16, 2008 | AN | RX | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Apotex Inc | ALBUTEROL SULFATE | albuterol sulfate | SOLUTION;INHALATION | 078623-002 | Apr 5, 2010 | 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 |
|---|---|---|---|---|---|---|---|
| Schering | PROVENTIL | albuterol sulfate | SYRUP;ORAL | 018062-001 | Jan 19, 1983 | ➤ Sign Up | ➤ Sign Up |
| Schering | PROVENTIL | albuterol sulfate | TABLET;ORAL | 017853-001 | May 7, 1982 | ➤ Sign Up | ➤ Sign Up |
| Schering | PROVENTIL | albuterol sulfate | TABLET;ORAL | 017853-002 | May 7, 1982 | ➤ Sign Up | ➤ Sign Up |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
International Patents for ALBUTEROL SULFATE
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ISSN: 2162-2639
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Site Map
DrugPatentWatch Alternatives
Major Patent Expirations 2019 - 2020
NCE-1 Generic Application Dates 2019 - 2020
Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2019, www.DrugPatentWatch.com.
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2019, www.DrugPatentWatch.com.