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QVAR REDIHALER Drug Patent Profile

Which patents cover Qvar Redihaler, and when can generic versions of Qvar Redihaler launch?

Qvar Redihaler is a drug marketed by Norton Waterford and is included in one NDA. There are fourteen patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and seventy-three patent family members in twenty-seven countries.

The generic ingredient in QVAR REDIHALER is beclomethasone dipropionate. There are twenty drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the beclomethasone dipropionate profile page.

DrugPatentWatch^® Generic Entry Outlook for Qvar Redihaler

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be September 7, 2028. This may change due to patent challenges or generic licensing.

There have been four patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There is one tentative approval for the generic drug (beclomethasone dipropionate), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for QVAR REDIHALER

International Patents:	273
US Patents:	14
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Clinical Trials:	1
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for QVAR REDIHALER
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for QVAR REDIHALER
What excipients (inactive ingredients) are in QVAR REDIHALER?	QVAR REDIHALER excipients list
DailyMed Link:	QVAR REDIHALER at DailyMed

See drug prices for QVAR REDIHALER

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for QVAR REDIHALER

NDA:

207921

Dosage:

AEROSOL, METERED;INHALATION

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for QVAR REDIHALER

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

Sponsor	Phase
Chiesi Farmaceutici S.p.A.	Phase 1
SGS S.A.	Phase 1

See all QVAR REDIHALER clinical trials

Pharmacology for QVAR REDIHALER

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Paragraph IV (Patent) Challenges for QVAR REDIHALER

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
QVAR REDIHALER	Inhalation Aerosol	beclomethasone dipropionate	40 mcg/actuation	207921	1	2023-10-30

US Patents and Regulatory Information for QVAR REDIHALER

QVAR REDIHALER is protected by fourteen US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting QVAR REDIHALER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Norton Waterford	QVAR REDIHALER	beclomethasone dipropionate	AEROSOL, METERED;INHALATION	207921-002	Aug 3, 2017		RX	Yes	No			Y
Norton Waterford	QVAR REDIHALER	beclomethasone dipropionate	AEROSOL, METERED;INHALATION	207921-001	Aug 3, 2017		RX	Yes	No			Y
Norton Waterford	QVAR REDIHALER	beclomethasone dipropionate	AEROSOL, METERED;INHALATION	207921-002	Aug 3, 2017		RX	Yes	No			Y
Norton Waterford	QVAR REDIHALER	beclomethasone dipropionate	AEROSOL, METERED;INHALATION	207921-002	Aug 3, 2017		RX	Yes	No			Y

Expired US Patents for QVAR REDIHALER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Norton Waterford	QVAR REDIHALER	beclomethasone dipropionate	AEROSOL, METERED;INHALATION	207921-001	Aug 3, 2017
Norton Waterford	QVAR REDIHALER	beclomethasone dipropionate	AEROSOL, METERED;INHALATION	207921-002	Aug 3, 2017
Norton Waterford	QVAR REDIHALER	beclomethasone dipropionate	AEROSOL, METERED;INHALATION	207921-001	Aug 3, 2017
Norton Waterford	QVAR REDIHALER	beclomethasone dipropionate	AEROSOL, METERED;INHALATION	207921-002	Aug 3, 2017

International Patents for QVAR REDIHALER

When does loss-of-exclusivity occur for QVAR REDIHALER?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Austria

Brazil

Canada

China

Denmark

Eurasian Patent Organization

European Patent Office

Hong Kong

Israel

Japan

Mexico

Portugal

South Korea

Spain

United Kingdom

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering QVAR REDIHALER around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	5785160
Australia	5329298
San Marino	T201400128	Inalatore
Eurasian Patent Organization	032332	СЧЕТЧИК ДОЗ ДЛЯ ИНГАЛЯТОРА И ИНГАЛЯТОР, СОДЕРЖАЩИЙ СЧЕТЧИК ДОЗ (DOSE COUNTER FOR AN INHALER AND INHALER COMPRISING A DOSE COUNTER)