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Last Updated: June 28, 2022

ALBUTEROL SULFATE Drug Patent Profile

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Which patents cover Albuterol Sulfate, and when can generic versions of Albuterol Sulfate launch?

Albuterol Sulfate is a drug marketed by Cipla, Lupin, Padagis Us, Sandoz Inc, Actavis Mid Atlantic, Akorn, Apotex Inc, Bausch And Lomb, Copley Pharm, Landela Pharm, Luoxin Aurovitas, Mylan Speclt, Nephron, Ritedose Corp, Roxane, Sun Pharm, Teva Pharms, Watson Labs, Watson Labs Inc, Wockhardt Eu Operatn, Amneal Pharms, Chartwell Rx, Cosette, Lannett Co Inc, Mova, Quagen, Teva, Rising, Am Therap, Amneal Pharms Co, Appco, Aurobindo Pharma Ltd, Eywa, Mylan, Pliva, Strides Pharma, Sun Pharm Industries, Ucb Inc, Virtus Pharm, Warner Chilcott, Zydus Pharms, Fosun Pharma, and Watson Labs Teva. and is included in eighty NDAs.

The generic ingredient in ALBUTEROL SULFATE is albuterol sulfate; ipratropium bromide. There are thirty-eight drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the albuterol sulfate; ipratropium bromide profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Albuterol Sulfate

A generic version of ALBUTEROL SULFATE was approved as albuterol sulfate; ipratropium bromide by CIPLA on December 31^st, 2007.

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Summary for ALBUTEROL SULFATE

US Patents:	0
Applicants:	43
NDAs:	80
Finished Product Suppliers / Packagers:	31
Raw Ingredient (Bulk) Api Vendors:	74
Clinical Trials:	43
Patent Applications:	5,851
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information 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

Drug patent expirations by year for ALBUTEROL SULFATE

Drug Prices for ALBUTEROL SULFATE

Recent Clinical Trials for ALBUTEROL SULFATE

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

Sponsor	Phase
Aurobindo Pharma Ltd	Phase 3
Teva Branded Pharmaceutical Products R&D, Inc.	Early Phase 1
University of North Carolina, Chapel Hill	Early Phase 1

See all ALBUTEROL SULFATE clinical trials

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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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Teva	ALBUTEROL SULFATE	albuterol sulfate	TABLET;ORAL	072779-001	Jun 25, 1993		DISCN	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Mova	ALBUTEROL SULFATE	albuterol sulfate	SYRUP;ORAL	074302-001	Sep 30, 1994		DISCN	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Watson Labs	ALBUTEROL SULFATE	albuterol sulfate	SOLUTION;INHALATION	077772-002	Sep 25, 2007	AN	RX	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Watson Labs	ALBUTEROL SULFATE	albuterol sulfate	TABLET;ORAL	072765-001	Aug 28, 1991		DISCN	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Amneal Pharms Co	ALBUTEROL SULFATE	albuterol sulfate	TABLET;ORAL	208804-001	May 21, 2018	AB	RX	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Eywa	ALBUTEROL SULFATE	albuterol sulfate	TABLET;ORAL	213524-002	Oct 8, 2020		DISCN	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Rising	ALBUTEROL SULFATE	albuterol sulfate	TABLET, EXTENDED RELEASE;ORAL	078092-002	Jan 29, 2007		DISCN	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
>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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