PROAIR DIGIHALER Drug Patent Profile

Which patents cover Proair Digihaler, and what generic alternatives are available?

Proair Digihaler is a drug marketed by Teva Branded Pharm and is included in one NDA. There are twenty-one patents protecting this drug.

This drug has three hundred and forty-three patent family members in twenty-nine countries.

The generic ingredient in PROAIR DIGIHALER is albuterol sulfate. There are thirty-eight drug master file entries for this compound. Forty-two suppliers are listed for this compound. Additional details are available on the albuterol sulfate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Proair Digihaler

A generic version of PROAIR DIGIHALER was approved as albuterol sulfate by SUN PHARM INDUSTRIES on December 5^th, 1989.

Summary for PROAIR DIGIHALER

International Patents:	343
US Patents:	21
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	81
Clinical Trials:	1
Patent Applications:	5,404
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for PROAIR DIGIHALER
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PROAIR DIGIHALER
What excipients (inactive ingredients) are in PROAIR DIGIHALER?	PROAIR DIGIHALER excipients list
DailyMed Link:	PROAIR DIGIHALER at DailyMed

See drug prices for PROAIR DIGIHALER

Recent Clinical Trials for PROAIR DIGIHALER

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

Sponsor	Phase
Wake Forest University Health Sciences	Early Phase 1
Teva Branded Pharmaceutical Products R&D, Inc.	Early Phase 1
University of North Carolina, Chapel Hill	Early Phase 1

See all PROAIR DIGIHALER clinical trials

Pharmacology for PROAIR DIGIHALER

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

US Patents and Regulatory Information for PROAIR DIGIHALER

PROAIR DIGIHALER is protected by twenty-one US patents.

Patents protecting PROAIR DIGIHALER

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 DIGIHALER	albuterol sulfate	POWDER, METERED;INHALATION	205636-002	Dec 21, 2018		RX	Yes	No			Y
Teva Branded Pharm	PROAIR DIGIHALER	albuterol sulfate	POWDER, METERED;INHALATION	205636-002	Dec 21, 2018		RX	Yes	No			Y
Teva Branded Pharm	PROAIR DIGIHALER	albuterol sulfate	POWDER, METERED;INHALATION	205636-002	Dec 21, 2018		RX	Yes	No			Y
Teva Branded Pharm	PROAIR DIGIHALER	albuterol sulfate	POWDER, METERED;INHALATION	205636-002	Dec 21, 2018		RX	Yes	No			Y
Teva Branded Pharm	PROAIR DIGIHALER	albuterol sulfate	POWDER, METERED;INHALATION	205636-002	Dec 21, 2018		RX	Yes	No			Y

Expired US Patents for PROAIR DIGIHALER

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
Teva Branded Pharm	PROAIR DIGIHALER	albuterol sulfate	POWDER, METERED;INHALATION	205636-002	Dec 21, 2018
Teva Branded Pharm	PROAIR DIGIHALER	albuterol sulfate	POWDER, METERED;INHALATION	205636-002	Dec 21, 2018
Teva Branded Pharm	PROAIR DIGIHALER	albuterol sulfate	POWDER, METERED;INHALATION	205636-002	Dec 21, 2018
Teva Branded Pharm	PROAIR DIGIHALER	albuterol sulfate	POWDER, METERED;INHALATION	205636-002	Dec 21, 2018

International Patents for PROAIR DIGIHALER

See the table below for patents covering PROAIR DIGIHALER around the world.

Country	Patent Number	Title	Estimated Expiration
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)
European Patent Office	3725350	DISPOSITIF D'INHALATION COMPORTANT UN MODULE ÉLECTRONIQUE INTÉGRÉ (INHALATION DEVICE WITH INTEGRATED ELECTRONICS MODULE)
South Korea	102491841
South Korea	101618933
Canada	3111537	COMPTEURS DE DOSES POUR INHALATEURS, INHALATEURS ET TIGES ASSOCIEES (DOSE COUNTERS FOR INHALERS, INHALERS AND SHAFTS THEREOF)