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Last Updated: May 19, 2024

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QVAR REDIHALER Drug Patent Profile


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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 fifteen 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

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  Try a Trial

Drug patent expirations by year for QVAR REDIHALER
Drug Prices for QVAR REDIHALER

See drug prices for QVAR REDIHALER

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for QVAR REDIHALER
Generic Entry Date for QVAR REDIHALER*:
Constraining patent/regulatory exclusivity:
NDA:
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

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

See all QVAR REDIHALER clinical trials

Pharmacology for QVAR REDIHALER
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 fifteen US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of QVAR REDIHALER is ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

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

Dose counter for inhaler having a bore and shaft arrangement
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Dose counters for inhalers, inhalers and methods of assembly thereof
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Dose counter for inhaler and method for counting doses
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Dose counter for inhaler having an anti-reverse rotation actuator
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Dose counter for inhaler having an anti-reverse rotation actuator
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Breath actuated inhaler
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Inhalers and related methods
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Dose counter for inhaler having an anti-reverse rotation actuator
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Metered-dose inhaler
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Inhaler
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  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
Norton Waterford QVAR REDIHALER beclomethasone dipropionate AEROSOL, METERED;INHALATION 207921-002 Aug 3, 2017 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Norton Waterford QVAR REDIHALER beclomethasone dipropionate AEROSOL, METERED;INHALATION 207921-002 Aug 3, 2017 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Norton Waterford QVAR REDIHALER beclomethasone dipropionate AEROSOL, METERED;INHALATION 207921-001 Aug 3, 2017 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  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 QVAR REDIHALER

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

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

Patent: 08234098
Estimated Expiration: ⤷  Try a Trial

Austria

Patent: 56386
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 0809477
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 82528
Estimated Expiration: ⤷  Try a Trial

China

Patent: 1657829
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 35199
Estimated Expiration: ⤷  Try a Trial

Eurasian Patent Organization

Patent: 6831
Estimated Expiration: ⤷  Try a Trial

Patent: 0970907
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 35199
Estimated Expiration: ⤷  Try a Trial

Hong Kong

Patent: 41349
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 1256
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 46968
Estimated Expiration: ⤷  Try a Trial

Patent: 10523184
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 09010600
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 35199
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 1475968
Estimated Expiration: ⤷  Try a Trial

Patent: 090127376
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 04818
Estimated Expiration: ⤷  Try a Trial

United Kingdom

Patent: 06999
Estimated Expiration: ⤷  Try a Trial

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
Canada 2936362 COMPTEURS DE DOSES POUR INHALATEURS, INHALATEURS ET TIGES ASSOCIEES (DOSE COUNTERS FOR INHALERS, INHALERS AND SHAFTS THEREOF) ⤷  Try a Trial
Austria 268619 ⤷  Try a Trial
South Korea 20130103825 DOSE COUNTERS FOR INHALERS, INHALERS AND SHAFTS THEREOF ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.