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Last Updated: May 7, 2024

Albuterol sulfate - Generic Drug Details

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What are the generic sources for albuterol sulfate and what is the scope of patent protection?

Albuterol sulfate is the generic ingredient in seventeen branded drugs marketed by Cipla, Lupin, Padagis Us, Sandoz, Teva Branded Pharm, Kindeva, Glaxosmithkline, Mylan Speciality Lp, Actavis Mid Atlantic, Apotex Inc, Bausch, Copley Pharm, Epic Pharma Llc, Landela Pharm, Luoxin Aurovitas, Mylan Speclt, Nephron, Ritedose Corp, Roxane, Sentiss, Sun Pharm, Teva Pharms, Watson Labs, Watson Labs Inc, Wockhardt Eu Operatn, Schering, Amneal Pharms, Chartwell Molecular, Chartwell Rx, Cosette, Hikma, Mova, Quagen, Teva, Rising, Muro, Strides Pharma, Aizant, Am Therap, Amneal Pharms Co, Aurobindo Pharma Ltd, Dash Pharms Natco, Eywa, Pliva, Sun Pharm Industries, Ucb Inc, Virtus Pharm, Warner Chilcott, Zydus Pharms, Astrazeneca, Boehringer Ingelheim, Fosun Pharma, and Watson Labs Teva, and is included in one hundred NDAs. There are thirty-five patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Albuterol sulfate has three hundred and sixty-three patent family members in twenty-nine countries.

There are eleven drug master file entries for albuterol sulfate. Forty-two suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for albuterol sulfate

International Patents:	363
US Patents:	35
Tradenames:	17
Applicants:	53
NDAs:	100
Drug Master File Entries:	11
Finished Product Suppliers / Packagers:	42
Raw Ingredient (Bulk) Api Vendors:	81
Clinical Trials:	44
Patent Applications:	6,475
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for albuterol sulfate
Drug Sales Revenues:	Drug sales revenues for albuterol sulfate
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for albuterol sulfate
What excipients (inactive ingredients) are in albuterol sulfate?	albuterol sulfate excipients list
DailyMed Link:	albuterol sulfate at DailyMed

See drug prices for albuterol sulfate

Drug Sales Revenue Trends for albuterol sulfate

See drug sales revenues for albuterol sulfate

Recent Clinical Trials for albuterol sulfate

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Parexel	Phase 3
Bond Avillion 2 Development LP	Phase 3
Aurobindo Pharma Ltd	Phase 3

See all albuterol sulfate clinical trials

Generic filers with tentative approvals for ALBUTEROL SULFATE

Applicant	Application No.	Strength	Dosage Form
⤷ Try a Trial	⤷ Try a Trial	EQ 0.083% BASE;0.017%	SOLUTION;INHALATION

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for albuterol sulfate

Drug Class	beta2-Adrenergic Agonist
Mechanism of Action	Adrenergic beta2-Agonists

Paragraph IV (Patent) Challenges for ALBUTEROL SULFATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
PROVENTIL-HFA	Inhalation Aerosol	albuterol sulfate	0.09 mg base per actuation	020503	1	2015-05-20
PROAIR HFA	Inhalation Aerosol	albuterol sulfate	0.09 mg base per actuation	021457	1	2012-05-18
ACCUNEB	Inhalation Solution	albuterol sulfate	0.021%	020949	1	2005-10-19
ACCUNEB	Inhalation Solution	albuterol sulfate	0.042%	020949	1	2004-04-06

US Patents and Regulatory Information for albuterol sulfate

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Chartwell Molecular	ALBUTEROL SULFATE	albuterol sulfate	SYRUP;ORAL	078105-001	Dec 27, 2006	AA	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Teva Branded Pharm	PROAIR DIGIHALER	albuterol sulfate	POWDER, METERED;INHALATION	205636-002	Dec 21, 2018		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Eywa	ALBUTEROL SULFATE	albuterol sulfate	TABLET;ORAL	213524-002	Oct 8, 2020		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Luoxin Aurovitas	ALBUTEROL SULFATE	albuterol sulfate	SOLUTION;INHALATION	211888-002	Apr 20, 2020		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Teva	ALBUTEROL SULFATE	albuterol sulfate	TABLET;ORAL	072938-001	Mar 30, 1990		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Aurobindo Pharma Ltd	ALBUTEROL SULFATE	albuterol sulfate	TABLET;ORAL	213657-002	May 14, 2020		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a 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 albuterol sulfate

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Muro	VOLMAX	albuterol sulfate	TABLET, EXTENDED RELEASE;ORAL	019604-001	Dec 23, 1992	⤷ Try a Trial	⤷ Try a Trial
Glaxosmithkline	VENTOLIN HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	020983-001	Apr 19, 2001	⤷ Try a Trial	⤷ Try a Trial
Mylan Speciality Lp	ACCUNEB	albuterol sulfate	SOLUTION;INHALATION	020949-002	Apr 30, 2001	⤷ Try a Trial	⤷ Try a Trial
Glaxosmithkline	VENTOLIN HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	020983-001	Apr 19, 2001	⤷ Try a Trial	⤷ Try a Trial
Glaxosmithkline	VENTOLIN HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	020983-001	Apr 19, 2001	⤷ Try a Trial	⤷ Try a Trial
Teva Branded Pharm	PROAIR HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	021457-001	Oct 29, 2004	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for albuterol sulfate

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Country	Patent Number	Title	Estimated Expiration
European Patent Office	2514467	Compteurs de doses pour inhalateurs et inhalateurs (Dose counters for inhalers and inhalers)	⤷ Try a Trial
Austria	506094		⤷ Try a Trial
Cyprus	1116092		⤷ Try a Trial
Hong Kong	1223311	用於吸入器的劑量計數器、吸入器及其軸 (DOSE COUNTERS FOR INHALERS, INHALERS AND SHAFTS THEREOF)	⤷ Try a Trial
Eurasian Patent Organization	201690640	СЧЕТЧИК ДОЗ ДЛЯ ИНГАЛЯТОРА И ИНГАЛЯТОР, СОДЕРЖАЩИЙ СЧЕТЧИК ДОЗ	⤷ Try a Trial
Israel	223117	מוני מינון למשאפים ומשאפים ועמודים למשאפים (Dose counters for inhalers and inhalers and shafts thereof)	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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