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VENTOLIN HFA Drug Profile
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Which patents cover Ventolin Hfa, and what generic alternatives are available?
Ventolin Hfa is a drug marketed by Glaxosmithkline and is included in one NDA. There are four patents protecting this drug.
This drug has one hundred and twenty patent family members in thirty-five countries.
The generic ingredient in VENTOLIN HFA is albuterol sulfate. There are thirty-eight drug master file entries for this compound. Thirty-nine suppliers are listed for this compound. Additional details are available on the albuterol sulfate profile page.
US ANDA Litigation and Generic Entry Outlook for Ventolin Hfa
A generic version of VENTOLIN HFA was approved as albuterol sulfate by SUN PHARM INDUSTRIES on January 21st, 2020.
Summary for VENTOLIN HFA
| International Patents: | 120 |
| US Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 10 |
| Bulk Api Vendors: | 59 |
| Clinical Trials: | 40 |
| Patent Applications: | 3,864 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for VENTOLIN HFA |
| Drug Sales Revenues: | Drug sales revenues for VENTOLIN HFA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for VENTOLIN HFA |
| DailyMed Link: | VENTOLIN HFA at DailyMed |
See drug prices for VENTOLIN HFA
Recent Clinical Trials for VENTOLIN HFA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Simbec Research | Phase 1 |
| AstraZeneca | Phase 1 |
| University of Nevada, Las Vegas | Phase 4 |
Recent Litigation for VENTOLIN HFA
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Glaxo Group Ltd. v. Teva Pharmaceuticals USA, Inc. | 2017-03-31 |
See all VENTOLIN HFA litigation
PTAB Litigation
| Petitioner | Date |
|---|---|
| Mylan Pharmaceuticals Inc. | 2015-09-29 |
Pharmacology for VENTOLIN HFA
| Drug Class | beta2-Adrenergic Agonist |
| Mechanism of Action | Adrenergic beta2-Agonists |
Synonyms for VENTOLIN HFA
| (+-)-Salbutamol sulfate |
| (+-)-ysulfate(2:1)(salt) |
| (C13H21NO3)2.H2SO4 |
| 022S709 |
| 1-(4-Hydroxy-3-hydroxymethylphenyl)-2-(tert-butylamino)ethanol sulfate |
| 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) |
| 36519-31-0 |
| 4-(2-(tert-butylamino)-1-hydroxyethyl)-2-(hydroxymethyl)phenol hemisulfate |
| 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 |
| AC1L22LX |
| AccuNeb |
| Accuneb (TN) |
| Accuvent |
| Aerotec |
| AH-3365 |
| AKOS015994719 |
| Albuterol hemisulfate |
| ALBUTEROL SULFATE |
| 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(2:1) |
| Aloprol |
| alpha(sup 1)-((tert-Butylamino)methyl)-4-hydroxy-m-xylene-alpha,alpha'-diol sulfate (2:1) (salt) |
| Amocasin |
| API0004123 |
| 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-222402 |
| CHEBI:2550 |
| CHEMBL1441059 |
| D00683 |
| Dipulmin |
| dl-Salbutamol sulfate |
| Eae -Ae |
| EINECS 256-916-8 |
| Emican |
| Epaq |
| EU-0101098 |
| Fartolin |
| FT-0650809 |
| H886 |
| HMS3263K18 |
| HMS3266D17 |
| Huma-Salmol |
| Inspiryl |
| J10322 |
| K-9412 |
| KS-00000RSS |
| KS-5056 |
| Loftan |
| LP01098 |
| LS-162604 |
| LS-29862 |
| MolPort-003-933-916 |
| NCGC00094370-01 |
| NCGC00261783-01 |
| NSC 289928 |
| Pediavent |
| ProAir |
| Proair HFA |
| Proair Respiclick |
| Proventil (TN) |
| Proventil Repetabs |
| Proventil Repetabs, Solution, Syrup, and Tablets |
| Proventil-HFA |
| Pulvinal salbutamol |
| S 5013 |
| S0531 |
| Salbutamol Diskus |
| Salbutamol Easyhaler |
| Salbutamol hemisulfate |
| Salbutamol hemisulfate salt |
| Salbutamol hemisulfate salt, >=98% |
| Salbutamol hemisulfate salt, VETRANAL(TM), analytical standard |
| Salbutamol sulfate |
| 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 sulphate (albuterol sulphate) |
| Salbutamol Sulphate (Albuterol Sulphate) 1.0 mg/ml in Methanol (as free base) |
| SC-18559 |
| Sch 13949W sulfate |
| SCHEMBL33279 |
| Sulbutamol sulphate |
| TBS-7 |
| TL8003382 |
| Tox21_501098 |
| TQ-1016 |
| Venetlin |
| Ventolin |
| Ventolin (TN) |
| Ventolin easy-breathe |
| Ventolin Nebules |
| Volare |
| VoSpire ER |
US Patents and Regulatory Information for VENTOLIN HFA
| 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 | ||
| Glaxosmithkline | VENTOLIN HFA | albuterol sulfate | AEROSOL, METERED;INHALATION | 020983-001 | Apr 19, 2001 | BX | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
| Glaxosmithkline | VENTOLIN HFA | albuterol sulfate | AEROSOL, METERED;INHALATION | 020983-001 | Apr 19, 2001 | BX | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
| Glaxosmithkline | VENTOLIN HFA | albuterol sulfate | AEROSOL, METERED;INHALATION | 020983-001 | Apr 19, 2001 | BX | RX | Yes | Yes | Start Trial | Start Trial | Y | 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 VENTOLIN HFA
| 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 | Start Trial | Start Trial |
| Glaxosmithkline | VENTOLIN HFA | albuterol sulfate | AEROSOL, METERED;INHALATION | 020983-001 | Apr 19, 2001 | Start Trial | Start Trial |
| Glaxosmithkline | VENTOLIN HFA | albuterol sulfate | AEROSOL, METERED;INHALATION | 020983-001 | Apr 19, 2001 | Start Trial | Start Trial |
| Glaxosmithkline | VENTOLIN HFA | albuterol sulfate | AEROSOL, METERED;INHALATION | 020983-001 | Apr 19, 2001 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for VENTOLIN HFA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Czech Republic | 9902323 | Start Trial |
| Denmark | 1516283 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2004001664 | Start Trial |
| Cyprus | 1108995 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
