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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:	3,495
Formulation / Manufacturing:	see details
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			Y
Glaxosmithkline	VENTOLIN HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	020983-001	Apr 19, 2001	BX	RX	Yes	Yes
Glaxosmithkline	VENTOLIN HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	020983-001	Apr 19, 2001	BX	RX	Yes	Yes
Glaxosmithkline	VENTOLIN HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	020983-001	Apr 19, 2001	BX	RX	Yes	Yes					Y

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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
Glaxosmithkline	VENTOLIN HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	020983-001	Apr 19, 2001
Glaxosmithkline	VENTOLIN HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	020983-001	Apr 19, 2001
Glaxosmithkline	VENTOLIN HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	020983-001	Apr 19, 2001

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
7,575,130	Indicating device
7,819,116	Medicament dispenser
8,157,128	Indicating device
8,505,773	Indicating device

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International Patents for VENTOLIN HFA

Country	Document Number	Estimated Expiration
Germany	69728580
Canada	2604067
European Patent Office	0988077
Hong Kong	1075955