DrugPatentWatch Database Preview
PROAIR HFA Drug Profile
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Which patents cover Proair Hfa, and when can generic versions of Proair Hfa launch?
This drug has two hundred and fifteen 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-four suppliers are listed for this compound. Additional details are available on the albuterol sulfate profile page.
Summary for PROAIR HFA
| International Patents: | 215 |
| US Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 10 |
| Bulk Api Vendors: | 130 |
| Clinical Trials: | 6 |
| Patent Applications: | 3,668 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for PROAIR HFA |
| DailyMed Link: | PROAIR HFA at DailyMed |
Pharmacology for PROAIR HFA
| Drug Class | beta2-Adrenergic Agonist |
| Mechanism of Action | Adrenergic beta2-Agonists |
Synonyms for PROAIR HFA
| .alpha.'-((tert-Butylamino)methyl)-4-hydroxy-m-xylene-.alpha.,.alpha.'-diol |
| .alpha.1-[(tert-Butylamino)methyl]-4-hydroxy-m-xylene-.alpha.,.alpha.'-diol |
| .alpha.1'-[[(1,1-Dimethylethyl)amino]methyl]-4-hydroxy-1,3-benzenedimethanol, hemisulfate |
| (+-)-Albuterol |
| (+-)-alpha(sup 1)-(((1,1-Dimethylethyl)amino)methyl)-4-hydroxy-1,3-benzenedimethanol |
| (+-)-Salbutamol |
| (+-)-Salbutamol sulfate |
| (alpha1-((tert-butylamino)methyl)-4-hydroxy-m-xylene-alpha,alpha-diol) |
| (C13H21NO3)2.H2SO4 |
| (l)-albuterol |
| 022S709 |
| 1-(4-Hydroxy-3-hydroxymethylphenyl)-2-(tert-butylamino)ethanol sulfate |
| 1-(tert-Butylaminomethyl)-4-hydroxy-m-xylene-.alpha.1,.alpha.3-diol |
| 1-(tert-Butylaminomethyl)-4-hydroxy-m-xylene-alpha1,alpha3-diol |
| 1,3-Benzenedimethanol, ?1-[[(1,1-dimethylethyl) amino]methyl]-4-hydroxy- |
| 1,3-Benzenedimethanol, .alpha.(1)-[[(1,1-dimethylethyl)amino]methyl]-4-hydroxy- |
| 1,3-Benzenedimethanol, .alpha.1-[[(1,1-dimethylethyl)amino]methyl]-4-hydroxy- |
| 1,3-Benzenedimethanol, alpha(sup 1)-(((1,1-dimethylethyl)amino)methyl)-4-hydroxy- |
| 1,3-Benzenedimethanol, alpha(sup 1)-(((1,1-dimethylethyl)amino)methyl)-4-hydroxy-, (+-)- |
| 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- |
| 1,3-Benzenedimethanol, alpha1-(((1,1-dimethylethyl)amino)methyl)-4-hydroxy-, sulfate (2:1) (salt) |
| 18559-94-9 |
| 2-(tert-Butylamino)-1-(4-hydroxy-3-hydroxymethylphenyl)ethanol |
| 2-(tert-Butylamino)-1-[4-hydroxy-3-(hydroxymethyl)phenyl]ethanol |
| 2-t-Butylamino-1-(4-hydroxy-3-hydroxy-3-hydroxymethyl)phenylethanol |
| 35763-26-9 |
| 36519-31-0 |
| 3B1-002494 |
| 4-(2-(tert-Butylamino)-1-hydroxyethyl)-2-(hydroxymethyl)phenol |
| 4-(2-(tert-butylamino)-1-hydroxyethyl)-2-(hydroxymethyl)phenol hemisulfate |
| 4-[(1S)-1-hydroxy-2-(propylamino)ethyl]-2-(hydroxymethyl)phenol, oxamethane |
| 4-[(1S)-2-(butylamino)-1-hydroxy-isopropyl]-2-(hydroxymethyl)phenol |
| 4-[2-(tert-butylamino)-1-hydroxy-ethyl]-2-(hydroxymethyl)phenol |
| 4-[2-(tert-Butylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol |
| 4-[2-(tert-Butylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol # |
| 4-[2-(tert-butylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol; sulfuric acid |
| 4-[2-(tert-butylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol;sulfuric acid |
| 4-[2-(tert-butylamino)-1-oxidanyl-ethyl]-2-(hydroxymethyl)phenol |
| 4-{2-[(1,1-dimethylethyl)amino]-1-hydroxyethyl}-2-(hydroxymethyl)phenol |
| 4-{2-[(tert-butyl)amino]-1-hydroxyethyl}-2-(hydroxymethyl)phenol |
| 4-Hydroxy-3-hydroxymethyl-.alpha.-((tert-butylamino)methyl)benzyl alcohol |
| 4-Hydroxy-3-hydroxymethyl-alpha-((tert-butylamino)methyl)benzyl alcohol |
| 5-[2-(tert-Butylamino)-1-hydroxyethyl]-2-hydroxybenzyl Alcohol Hemisulfate |
| 51022-70-9 |
| 559S949 |
| A812971 |
| AB00052154 |
| AB00052154_10 |
| AB00052154_11 |
| AB00052154-08 |
| AB00052154-09 |
| AB0011383 |
| AB0013333 |
| AB1006817 |
| AC-10286 |
| AC1L1CVO |
| AC1L22LX |
| AC1Q1MO0 |
| AccuNeb |
| Accuneb (TN) |
| Accuvent |
| ACM35763269 |
| Aerolin |
| Aerolin (TN) |
| Aerotec |
| AH 3365 |
| AH-3365 |
| Airomir |
| AK139997 |
| AKOS007930174 |
| AKOS015994719 |
| albuterol |
| ALBUTEROL (+/-) |
| Albuterol (USP) |
| Albuterol [USAN:USP] |
| Albuterol [USAN] |
| 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) |
| Albuterol Sulphate |
| Albuterol, United States Pharmacopeia (USP) Reference Standard |
| Almotex |
| Aloprol |
| alpha-[(t-Butylamino)methyl]-4-hydroxy-m-xylene-alpha,alpha -diol |
| Alpha-[(t-Butylamino)methyl]-4-hydroxy-m-xylene-alpha,alpha-diol |
| alpha-[(t-Butylamino)methyl]-4-hydroxy-m-xylene-alpha,alpha'-diol |
| alpha-[(tert-Butylamino)methyl]-4-hydroxy-1,3-benzenedimethanol sulfate |
| alpha-[(tert-Butylamino)methyl]-4-hydroxy-m-xylene-alpha,alpha'-diol |
| alpha'-((tert-Butylamino)methyl)-4-hydroxy-m-xylene-alpha,alpha'-diol |
| alpha(sup 1)-((tert-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) |
| Alti-Salbutamol |
| Amocasin |
| AN-18804 |
| AN-7048 |
| Anebron |
| API0004123 |
| API0006973 |
| Arubendol-Salbutamol |
| Asmadil |
| Asmanil |
| Asmasal |
| Asmatol |
| Asmaven |
| Asmidon |
| Asmol |
| Asmol Uni-Dose |
| Asthalin |
| Asthalin (TN) |
| Asthavent |
| AX8136202 |
| BCBcMAP01_000116 |
| BDBM25769 |
| BG0312 |
| Bio1_000446 |
| Bio1_000935 |
| Bio1_001424 |
| Bis((tert-butyl)(beta,3,4-trihydroxyphenethyl)ammonium) sulphate |
| bis(salbutamol); sulfuric acid |
| BIS7017 |
| BPBio1_000171 |
| BRD-A88254928-001-04-6 |
| BRN 2213614 |
| Broncho Inhalat |
| Broncho-Spray |
| Bronchospray |
| Broncodil |
| Broncovaleas |
| Bronter |
| BSPBio_000155 |
| Bugonol |
| Bumol |
| Butamol |
| Buto-Asma |
| Butohaler |
| Butotal |
| Butovent |
| Buventol |
| Buventol Easyhaler |
| C-14301 |
| C13H21NO3??1/2H2SO4 |
| C13H21NO3.H2O4S |
| CA0122 |
| CAS-18559-94-9 |
| CC-23825 |
| CCG-222402 |
| CCG-39288 |
| Cetsim |
| CHEBI:2549 |
| CHEBI:2550 |
| CHEMBL1441059 |
| CHEMBL714 |
| Cobutolin |
| Combivent |
| CS-4556 |
| CS0015 |
| CTK8E5622 |
| D00683 |
| D02147 |
| D0K5CB |
| DB01001 |
| Dilatamol |
| Dipulmin |
| DivK1c_000943 |
| dl-Albuterol |
| DL-N-tert-Butyl-2-(4-hydroxy-3-hydroxymethylphenyl)-2-hydroxyethylamine |
| dl-Salbutamol |
| dl-Salbutamol sulfate |
| DSSTox_CID_1255 |
| DSSTox_GSID_21255 |
| DSSTox_RID_76042 |
| DTXSID5021255 |
| Eae -Ae |
| EC 242-424-0 |
| Ecovent |
| EINECS 242-424-0 |
| EINECS 256-916-8 |
| Emican |
| Eolene |
| Epaq |
| EU-0101090 |
| EU-0101098 |
| Farcolin |
| Fartolin |
| FT-0630453 |
| FT-0650809 |
| Gerivent |
| Grafalin |
| GTPL558 |
| H886 |
| HMS1568H17 |
| HMS1921C04 |
| HMS2089I19 |
| HMS2092I08 |
| HMS2095H17 |
| HMS3263K18 |
| HMS3266D17 |
| HMS502P05 |
| HSDB 7206 |
| Huma-Salmol |
| HY-B1037 |
| I06-0331 |
| IDI1_000943 |
| Inspiryl |
| J10176 |
| J10322 |
| K-5595 |
| K-9412 |
| KBio1_000943 |
| KBio2_000680 |
| KBio2_003248 |
| KBio2_005816 |
| KBioGR_001294 |
| KBioSS_000680 |
| KS-00000RSS |
| KS-5056 |
| KS-5209 |
| KSC-11-222-1 |
| KUC106739N |
| L000531 |
| Levosalbutamol Hydrochloride |
| Libretin |
| Loftan |
| Lopac0_001090 |
| Lopac0_001098 |
| LP01098 |
| LS-162604 |
| LS-29861 |
| LS-29862 |
| LS-7693 |
| m-Xylene-.alpha.,.alpha.-diol, .alpha.-1-((tert-butylamino)methyl)-4-hydroxy- |
| m-Xylene-.alpha.,.alpha.'-diol, .alpha.'-((tert-butylamino)methyl)-4-hydroxy- |
| m-Xylene-alpha,alpha'-diol, alpha-((tert-butylamino)methyl)-4-hydroxy- |
| m-Xylene-alpha,alpha'-diol, alpha'-((tert-butylamino)methyl)-4-hydroxy- |
| MCULE-4493408325 |
| Medolin |
| MFCD00055200 |
| MFCD00148978 |
| MolPort-001-838-925 |
| MolPort-003-933-916 |
| Mozal |
| NCGC00015955-04 |
| NCGC00015955-05 |
| NCGC00015955-06 |
| NCGC00015955-07 |
| NCGC00015955-08 |
| NCGC00015955-09 |
| NCGC00015955-10 |
| NCGC00015955-11 |
| NCGC00015955-12 |
| NCGC00015955-13 |
| NCGC00015955-14 |
| NCGC00015955-16 |
| NCGC00024698-02 |
| NCGC00024698-03 |
| NCGC00024698-04 |
| NCGC00024698-05 |
| NCGC00024698-06 |
| NCGC00024698-07 |
| NCGC00094370-01 |
| NCGC00258354-01 |
| NCGC00261783-01 |
| NDAUXUAQIAJITI-UHFFFAOYSA-N |
| NINDS_000943 |
| Novosalmol |
| NSC 289928 |
| NSC-757417 |
| NSC757417 |
| OR057581 |
| OR076774 |
| OR206945 |
| OR262364 |
| Parasma |
| PDSP1_000623 |
| PDSP2_000620 |
| Pediavent |
| Pharmakon1600-01500677 |
| Pneumolat |
| Prestwick_665 |
| Prestwick0_000198 |
| Prestwick1_000198 |
| Prestwick2_000198 |
| Prestwick3_000198 |
| ProAi (TN) |
| ProAir |
| Proair Respiclick |
| Proventil |
| Proventil (TN) |
| Proventil HFA |
| Proventil Inhaler |
| Proventil Repetabs |
| Proventil Repetabs, Solution, Syrup, and Tablets |
| Proventil-HFA |
| Pulvinal salbutamol |
| Q-201695 |
| Q-201696 |
| R,S-Albuterol |
| racemic salbutamol |
| racemic-Salbutamol |
| Respax |
| Respolin |
| Rotahaler |
| S 5013 |
| S 8260 |
| S0531 |
| sabumol |
| Sabutal |
| Sabutamol |
| Salamol |
| Salamol EB |
| Salbetol |
| Salbron |
| Salbu-BASF |
| Salbu-Fatol |
| Salbuhexal |
| Salbulin |
| Salbupur |
| Salbusian |
| Salbutalan |
| Salbutamol |
| Salbutamol [INN:BAN] |
| Salbutamol Diskus |
| Salbutamol Easyhaler |
| Salbutamol Free Base |
| Salbutamol free base 100 microg/mL in Acetonitrile |
| Salbutamol hemisulfate |
| Salbutamol hemisulfate salt |
| Salbutamol hemisulfate salt, >=98% |
| Salbutamol hemisulfate salt, VETRANAL(TM), analytical standard |
| Salbutamol impurity I (1RS)-2-[(1,1-dimethylethyl) |
| 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 |
| salbutamol sulphate (albuterol sulphate) |
| Salbutamol Sulphate (Albuterol Sulphate) 1.0 mg/ml in Methanol (as free base) |
| Salbutamol-d9 |
| Salbutamol, 99% 250mg |
| Salbutamol, European Pharmacopoeia (EP) Reference Standard |
| Salbutamol, VETRANAL(TM), analytical standard |
| Salbutamol,(+/-) |
| Salbutamolum |
| Salbutamolum [INN-Latin] |
| Salbutan |
| Salbutard |
| Salbutine |
| Salbutol |
| Salbuven |
| Salbuvent |
| Sallbupp |
| Salmaplon |
| Salomol |
| Salvent |
| Saventol |
| SBB066105 |
| SBI-0051060.P005 |
| SC-18559 |
| SC-22638 |
| SC-93513 |
| Sch 13949W sulfate |
| SCH-13949W |
| SCHEMBL10025126 |
| SCHEMBL33279 |
| SCHEMBL4913 |
| Servitamol |
| SGCUT00011 |
| SMP1_000268 |
| Solbutamol |
| SPBio_001539 |
| SPBio_002076 |
| Spectrum_000200 |
| SPECTRUM1500677 |
| Spectrum2_001350 |
| Spectrum4_000887 |
| Spectrum5_001059 |
| Spreor |
| ST024764 |
| ST075204 |
| ST077150 |
| ST24042831 |
| Sultanol |
| Sultanol N |
| Suprasma |
| Suxar |
| TBS-7 |
| Theosal |
| TL8003382 |
| to_000081 |
| Tobybron |
| Tox21_110266 |
| Tox21_110266_1 |
| Tox21_200800 |
| Tox21_501098 |
| TQ-1016 |
| TR-008568 |
| Vencronyl |
| Venetlin |
| Venetlin (Salt/Mix) |
| Ventalin inhaler |
| Ventamol |
| Ventilan |
| Ventiloboi |
| Ventodisks |
| Ventolin |
| Ventolin (TN) |
| Ventolin easy-breathe |
| Ventolin HFA |
| Ventolin Inhaler |
| Ventolin Nebules |
| Ventolin Rotacaps |
| Ventoline |
| Volare |
| Volare albuterol HFA |
| Volare easi-breathe |
| Volma |
| Volmax |
| Vospire |
| VoSpire ER |
| VU0243312-5 |
| Zaperin |
| ZX-AFC000812 |
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 | BX | RX | Yes | Yes | ➤ Try a Free Trial | ➤ Try a Free Trial | Y | ➤ Try a Free Trial | ||
| Teva Branded Pharm | PROAIR HFA | albuterol sulfate | AEROSOL, METERED;INHALATION | 021457-001 | Oct 29, 2004 | BX | RX | Yes | Yes | ➤ Try a Free Trial | ➤ Try a Free Trial | Y | ➤ Try a Free Trial | ||
| Teva Branded Pharm | PROAIR HFA | albuterol sulfate | AEROSOL, METERED;INHALATION | 021457-001 | Oct 29, 2004 | BX | RX | Yes | Yes | ➤ Try a Free Trial | ➤ Try a Free Trial | Y | ➤ Try a Free Trial | ||
| Teva Branded Pharm | PROAIR HFA | albuterol sulfate | AEROSOL, METERED;INHALATION | 021457-001 | Oct 29, 2004 | BX | RX | Yes | Yes | ➤ Try a Free Trial | ➤ Try a Free Trial | Y | ➤ Try a Free Trial | ||
| 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 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 | ➤ Try a Free Trial | ➤ Try a Free Trial |
| Teva Branded Pharm | PROAIR HFA | albuterol sulfate | AEROSOL, METERED;INHALATION | 021457-001 | Oct 29, 2004 | ➤ Try a Free Trial | ➤ Try a Free Trial |
| Teva Branded Pharm | PROAIR HFA | albuterol sulfate | AEROSOL, METERED;INHALATION | 021457-001 | Oct 29, 2004 | ➤ Try a Free Trial | ➤ Try a Free Trial |
| Teva Branded Pharm | PROAIR HFA | albuterol sulfate | AEROSOL, METERED;INHALATION | 021457-001 | Oct 29, 2004 | ➤ Try a Free Trial | ➤ Try a Free Trial |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
Non-Orange Book US Patents for PROAIR 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 |
|---|---|---|
| 9,526,850 | Dose counters for inhalers, inhalers and methods of assembly thereof | ➤ Try a Free Trial |
| 8,978,966 | Dose counters for inhalers, inhalers and methods of assembly thereof | ➤ Try a Free Trial |
| 6,743,413 | Suspension aerosol formulations | ➤ Try a Free Trial |
| 9,216,260 | Dose counters for inhalers, inhalers and methods of assembly thereof | ➤ Try a Free Trial |
| Patent No. | Title | Estimated Patent Expiration |
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International Patents for PROAIR HFA
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Eurasian Patent Organization | 200970907 | ➤ Try a Free Trial |
| Eurasian Patent Organization | 201300237 | ➤ Try a Free Trial |
| European Patent Office | 2514463 | ➤ Try a Free Trial |
| European Patent Office | 2514464 | ➤ Try a Free Trial |
| Country | Document Number | Estimated Expiration |
