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Last Updated: April 26, 2024

Albuterol sulfate - Generic Drug Details

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What are the generic sources for albuterol sulfate and what is the scope of freedom to operate?

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
Bond Avillion 2 Development LP	Phase 3
Parexel	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
Nephron	ALBUTEROL SULFATE	albuterol sulfate	SOLUTION;INHALATION	076355-001	Jun 28, 2004	AN	RX	No	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Actavis Mid Atlantic	ALBUTEROL SULFATE	albuterol sulfate	SOLUTION;INHALATION	073533-001	Sep 26, 1995		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Roxane	ALBUTEROL SULFATE	albuterol sulfate	SOLUTION;INHALATION	075129-001	Feb 13, 2001		DISCN	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
Glaxosmithkline	VENTOLIN	albuterol sulfate	SYRUP;ORAL	019621-001	Jun 10, 1987		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
Teva Branded Pharm	PROAIR DIGIHALER	albuterol sulfate	POWDER, METERED;INHALATION	205636-002	Dec 21, 2018	⤷ 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 RESPICLICK	albuterol sulfate	POWDER, METERED;INHALATION	205636-001	Mar 31, 2015	⤷ Try a Trial	⤷ Try a Trial
Teva Branded Pharm	PROAIR RESPICLICK	albuterol sulfate	POWDER, METERED;INHALATION	205636-001	Mar 31, 2015	⤷ 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
South Africa	201307995	DOSE COUNTERS FOR INHALERS, INHALERS AND SHAFTS THEREOF	⤷ Try a Trial
China	106714880	呼吸驱动吸入器的依从性监控模块 (Compliance monitoring module for a breath-actuated inhaler)	⤷ Try a Trial
Eurasian Patent Organization	026600	УПРАВЛЯЕМЫЙ ВРУЧНУЮ ИНГАЛЯТОР ОТМЕРЕННЫХ ДОЗ ЛЕКАРСТВЕННЫХ ПРЕПАРАТОВ (MANUALLY OPERATED INHALER FOR MEASURED DOSES OF MEDICAMENTS)	⤷ Try a Trial
South Korea	101618936		⤷ Try a Trial
European Patent Office	3552646	DISPOSITIF D'ADMINISTRATION DE MÉDICAMENT COMPRENANT UNE ÉLECTRONIQUE (DRUG DELIVERY DEVICE WITH ELECTRONICS)	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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