DrugPatentWatch Database Preview
Albuterol sulfate - Generic Drug Details
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 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, Quagen, 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 ninety 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 five hundred and five patent family members in forty-two countries.
There are thirty-eight 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: | 505 |
| US Patents: | 36 |
| Tradenames: | 16 |
| Applicants: | 45 |
| NDAs: | 90 |
| Drug Master File Entries: | 38 |
| Suppliers / Packagers: | 45 |
| Bulk Api Vendors: | 96 |
| Clinical Trials: | 26 |
| Patent Applications: | 6,146 |
| 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 |
Recent Clinical Trials for albuterol sulfate
Identify potential brand extensions & 505(b)(2) entrants
| 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
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| MYLAN SPECIALTY L.P. v. AUROBINDO PHARMA USA INC. | 2018-10-22 |
| Glaxo Group Ltd. v. Teva Pharmaceuticals USA, Inc. | 2017-03-31 |
| Teva Branded Pharmaceutical Products R&D, Inc. v. Lupin Alantis Holdings SA | 2017-03-21 |
See all albuterol sulfate litigation
PTAB Litigation
| Petitioner | Date |
|---|---|
| Mylan Pharmaceuticals Inc. | 2015-09-29 |
Generic filers with tentative approvals for ALBUTEROL SULFATE
| Applicant | Application No. | Strength | Dosage Form |
| Start Trial | Start Trial | 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 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Glaxosmithkline | VENTOLIN HFA | albuterol sulfate | AEROSOL, METERED;INHALATION | 020983-001 | Apr 19, 2001 | BX | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
| Mylan Speciality Lp | ACCUNEB | albuterol sulfate | SOLUTION;INHALATION | 020949-001 | Apr 30, 2001 | AN | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
| Quagen | ALBUTEROL SULFATE | albuterol sulfate | SYRUP;ORAL | 212197-001 | Sep 6, 2019 | AA | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Schering | PROVENTIL | albuterol sulfate | TABLET;ORAL | 017853-002 | May 7, 1982 | DISCN | Yes | 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 |
Expired US Patents for albuterol sulfate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Teva Branded Pharm | PROAIR HFA | albuterol sulfate | AEROSOL, METERED;INHALATION | 021457-001 | Oct 29, 2004 | Start Trial | Start Trial |
| Muro | VOLMAX | albuterol sulfate | TABLET, EXTENDED RELEASE;ORAL | 019604-001 | Dec 23, 1992 | Start Trial | Start Trial |
| Schering | PROVENTIL | albuterol sulfate | SOLUTION;INHALATION | 019243-002 | Jan 14, 1987 | Start Trial | Start Trial |
| Muro | VOLMAX | albuterol sulfate | TABLET, EXTENDED RELEASE;ORAL | 019604-002 | Dec 23, 1992 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for albuterol sulfate
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| South Korea | 100503235 | Start Trial |
| Canada | 3019694 | Start Trial |
| Spain | 2216800 | Start Trial |
| Eurasian Patent Organization | 026306 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
Serving leading biopharmaceutical companies globally:
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
Copyright 2002-2019 thinkBiotech LLC
ISSN: 2162-2639
Privacy and Cookies
Terms & Conditions
Site Map
DrugPatentWatch Alternatives
LOE / Major Patent Expirations 2019 - 2020
NCE-1 Patent Challenge Dates 2019 - 2020
ISSN: 2162-2639
Privacy and Cookies
Terms & Conditions
Site Map
DrugPatentWatch Alternatives
LOE / Major Patent Expirations 2019 - 2020
NCE-1 Patent Challenge Dates 2019 - 2020
Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2019, www.DrugPatentWatch.com.