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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 fifteen patents protecting this drug.
This drug has two hundred and nineteen patent family members in forty countries.
The generic ingredient in VENTOLIN HFA is albuterol sulfate. There are thirty-eight drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the albuterol sulfate profile page.
Summary for VENTOLIN HFA
| International Patents: | 219 |
| US Patents: | 15 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 13 |
| Bulk Api Vendors: | 49 |
| Clinical Trials: | 35 |
| Patent Applications: | 3,537 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for VENTOLIN HFA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for VENTOLIN HFA |
| DailyMed Link: | VENTOLIN HFA at DailyMed |
Pharmacology for VENTOLIN HFA
| Drug Class | beta2-Adrenergic Agonist |
| Mechanism of Action | Adrenergic beta2-Agonists |
Synonyms for VENTOLIN HFA
| (+-)-Salbutamol sulfate |
| (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; traceable to USP, PhEur and BP |
| Albuterol sulfate, United States Pharmacopeia (USP) Reference Standard |
| Albuterol Sulfate,(S) |
| Albuterol sulfate(2:1) |
| Aloprol |
| alpha-[(tert-Butylamino)methyl]-4-hydroxy-1,3-benzenedimethanol sulfate |
| 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 |
| MFCD00055200 |
| MolPort-003-933-916 |
| NCGC00094370-01 |
| NCGC00261783-01 |
| NSC 289928 |
| OR076774 |
| Pediavent |
| Proair HFA |
| Proair Respiclick |
| 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, 99% 1g |
| 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 |
| 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 | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | ||
| Glaxosmithkline | VENTOLIN HFA | albuterol sulfate | AEROSOL, METERED;INHALATION | 020983-001 | Apr 19, 2001 | BX | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Glaxosmithkline | VENTOLIN HFA | albuterol sulfate | AEROSOL, METERED;INHALATION | 020983-001 | Apr 19, 2001 | BX | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Glaxosmithkline | VENTOLIN HFA | albuterol sulfate | AEROSOL, METERED;INHALATION | 020983-001 | Apr 19, 2001 | BX | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | ||
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
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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 | ➤ Sign Up | ➤ Sign Up |
| Glaxosmithkline | VENTOLIN HFA | albuterol sulfate | AEROSOL, METERED;INHALATION | 020983-001 | Apr 19, 2001 | ➤ Sign Up | ➤ Sign Up |
| Glaxosmithkline | VENTOLIN HFA | albuterol sulfate | AEROSOL, METERED;INHALATION | 020983-001 | Apr 19, 2001 | ➤ Sign Up | ➤ Sign Up |
| Glaxosmithkline | VENTOLIN HFA | albuterol sulfate | AEROSOL, METERED;INHALATION | 020983-001 | Apr 19, 2001 | ➤ Sign Up | ➤ Sign Up |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
Non-Orange Book US Patents for VENTOLIN HFA
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration |
|---|---|---|
| 8,157,128 | Indicating device | ➤ Sign Up |
| 6,142,339 | Aerosol dispensing device | ➤ Sign Up |
| 7,191,777 | Medicament dispenser | ➤ Sign Up |
| 8,505,773 | Indicating device | ➤ Sign Up |
| Patent No. | Title | Estimated Patent Expiration |
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International Patents for VENTOLIN HFA
| Country | Document Number | Estimated Expiration |
|---|---|---|
| World Intellectual Property Organization (WIPO) | 9856445 | ➤ Sign Up |
| China | 1094876 | ➤ Sign Up |
| United Kingdom | 9626960 | ➤ Sign Up |
| United Kingdom | 9924468 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
