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ALBUTEROL SULFATE Drug Profile
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Albuterol Sulfate is a drug marketed by 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, Amneal Pharms, Cosette, Lannett Co Inc, Mova, Quagen, Teva, Vistapharm, Mylan, Am Therap, Amneal Pharms Co, Appco, Arise, Dava Pharms Inc, Pliva, Sun Pharm Industries, Ucb Inc, Virtus Pharm, Warner Chilcott, Yaopharma Co Ltd, Cipla, Fosun Pharma, and Watson Labs Teva. and is included in seventy-one NDAs.
The generic ingredient in ALBUTEROL SULFATE is albuterol sulfate; ipratropium bromide. There are thirty-eight drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the albuterol sulfate; ipratropium bromide profile page.
Summary for ALBUTEROL SULFATE
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Recent Clinical Trials for ALBUTEROL SULFATE
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| Sponsor | Phase |
|---|---|
| Sun Pharmaceutical Industries Limited | Phase 3 |
| Amneal Ireland Limited | Phase 3 |
| People's Hospital of Xinjiang Uygur Autonomous Region | N/A |
Recent Litigation for ALBUTEROL SULFATE
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District Court Litigation
| Case Name | Date |
|---|---|
| MYLAN SPECIALTY L.P. v. AUROBINDO PHARMA USA INC. | 2018-10-22 |
| SHIONOGI INC. v. ZYDUS PHARMACEUTICALS (USA) INC. | 2018-08-16 |
| Glaxo Group Ltd. v. Teva Pharmaceuticals USA, Inc. | 2017-03-31 |
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PTAB Litigation
| Petitioner | Date |
|---|---|
| Mylan Pharmaceuticals Inc. | 2015-09-29 |
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 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Watson Labs | ALBUTEROL SULFATE | albuterol sulfate | TABLET;ORAL | 072765-001 | Aug 28, 1991 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Amneal Pharms Co | ALBUTEROL SULFATE | albuterol sulfate | TABLET;ORAL | 208804-001 | May 21, 2018 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Mova | ALBUTEROL SULFATE | albuterol sulfate | SYRUP;ORAL | 074302-001 | Sep 30, 1994 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Dava Pharms Inc | ALBUTEROL SULFATE | albuterol sulfate | TABLET;ORAL | 072860-002 | Dec 20, 1989 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Teva | ALBUTEROL SULFATE | albuterol sulfate | TABLET;ORAL | 072620-001 | Dec 5, 1989 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Arise | ALBUTEROL SULFATE | albuterol sulfate | TABLET;ORAL | 210948-001 | Mar 15, 2019 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
