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PROAIR HFA Drug Profile
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» See Plans and PricingWhen do Proair Hfa patents expire, and what generic alternatives are available?
Proair Hfa is a drug marketed by Teva Branded Pharm and is included in one NDA. There are eight patents protecting this drug.
This drug has two hundred and forty-one patent family members in twenty-eight countries.
The generic ingredient in PROAIR HFA is albuterol sulfate. There are thirty-eight drug master file entries for this compound. Forty suppliers are listed for this compound. Additional details are available on the albuterol sulfate profile page.
US ANDA Litigation and Generic Entry Outlook for Proair Hfa
A generic version of PROAIR HFA was approved as albuterol sulfate by SUN PHARM INDUSTRIES on December 5th, 1989.
Summary for PROAIR HFA
| International Patents: | 241 |
| US Patents: | 8 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 9 |
| Bulk Api Vendors: | 61 |
| Clinical Trials: | 8 |
| Patent Applications: | 3,864 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for PROAIR HFA |
| Drug Sales Revenues: | Drug sales revenues for PROAIR HFA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for PROAIR HFA |
| DailyMed Link: | PROAIR HFA at DailyMed |
See drug prices for PROAIR HFA
Recent Clinical Trials for PROAIR HFA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Sun Pharmaceutical Industries Limited | Phase 3 |
| Amneal Ireland Limited | Phase 3 |
| Oregon Health and Science University | Phase 4 |
Recent Litigation for PROAIR HFA
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Teva Branded Pharmaceutical Products R&D, Inc. v. Lupin Alantis Holdings SA | 2017-03-21 |
| Teva Branded Pharmaceutical Products R&D Inc. v. Perrigo Pharmaceuticals Co. | 2013-08-16 |
| ORTHO-MCNEIL PHARMACEUTICAL, INC. v. LUPIN PHARMACEUTICALS, INC. | 2006-10-17 |
PTAB Litigation
| Petitioner | Date |
|---|---|
| 2018-10-26 |
Pharmacology for PROAIR HFA
| Drug Class | beta2-Adrenergic Agonist |
| Mechanism of Action | Adrenergic beta2-Agonists |
Synonyms for PROAIR 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.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 |
| 36519-31-0 |
| 4-(2-(tert-butylamino)-1-hydroxyethyl)-2-(hydroxymethyl)phenol hemisulfate |
| 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 |
| 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 |
| Broncho Inhalat |
| Bronchospray |
| Broncodil |
| Buventol Easyhaler |
| C13H21NO3??1/2H2SO4 |
| C13H21NO3.H2O4S |
| CA0122 |
| CCG-222402 |
| CHEBI:2550 |
| CHEMBL1441059 |
| D00683 |
| Dipulmin |
| dl-Salbutamol sulfate |
| DTXSID10881180 |
| 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 |
| NCGC00094370-01 |
| NCGC00261783-01 |
| NSC 289928 |
| NSC-289928 |
| Pediavent |
| ProAir |
| Proair Respiclick |
| Proventil (TN) |
| Proventil Repetabs |
| Proventil Repetabs, Solution, Syrup, and Tablets |
| Proventil-HFA |
| Pulvinal salbutamol |
| Q27231480 |
| R03AC02 |
| R03CC02 |
| 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 |
| SCH-13949W Sulfate |
| SCHEMBL33279 |
| Sulbutamol sulphate |
| TBS-7 |
| Tox21_501098 |
| TQ-1016 |
| Venetlin |
| Ventolin |
| Ventolin (TN) |
| Ventolin easy-breathe |
| Ventolin HFA |
| Ventolin Nebules |
| Ventolin Rotacaps |
| Volare |
| VoSpire ER |
Paragraph IV (Patent) Challenges for PROAIR HFA
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| PROAIR HFA | AEROSOL, METERED;INHALATION | albuterol sulfate | 021457 | 2012-05-18 |
US Patents and Regulatory Information for PROAIR HFA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Teva Branded Pharm | PROAIR HFA | albuterol sulfate | AEROSOL, METERED;INHALATION | 021457-001 | Oct 29, 2004 | AB2 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
| Teva Branded Pharm | PROAIR HFA | albuterol sulfate | AEROSOL, METERED;INHALATION | 021457-001 | Oct 29, 2004 | AB2 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
| Teva Branded Pharm | PROAIR HFA | albuterol sulfate | AEROSOL, METERED;INHALATION | 021457-001 | Oct 29, 2004 | AB2 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
| Teva Branded Pharm | PROAIR HFA | albuterol sulfate | AEROSOL, METERED;INHALATION | 021457-001 | Oct 29, 2004 | AB2 | 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 PROAIR HFA
| 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 |
| Teva Branded Pharm | PROAIR HFA | albuterol sulfate | AEROSOL, METERED;INHALATION | 021457-001 | Oct 29, 2004 | Start Trial | Start Trial |
| Teva Branded Pharm | PROAIR HFA | albuterol sulfate | AEROSOL, METERED;INHALATION | 021457-001 | Oct 29, 2004 | Start Trial | Start Trial |
| Teva Branded Pharm | PROAIR HFA | albuterol sulfate | AEROSOL, METERED;INHALATION | 021457-001 | Oct 29, 2004 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for PROAIR HFA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | 6227608 | Start Trial |
| Spain | 2707498 | Start Trial |
| Hungary | E026784 | Start Trial |
| Australia | 5329298 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
