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 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 |
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
Sponsor | Phase |
---|---|
Chiesi Farmaceutici S.p.A. | Phase 1 |
SGS S.A. | Phase 1 |
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.
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
Metered-dose inhaler
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Inhaler
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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 | 207921-001 | 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 |
---|---|---|---|
South Korea | 101475968 | ⤷ Try a Trial | |
China | 101657829 | Metered-dose inhaler | ⤷ Try a Trial |
Denmark | 2502644 | ⤷ Try a Trial | |
Japan | 6301904 | ⤷ Try a Trial | |
Hong Kong | 1222811 | 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) | ⤷ Try a Trial |
Japan | 2017205580 | 吸入器のための用量カウンタ、吸入器及びそのシャフト (DOSE COUNTERS FOR INHALERS, INHALERS, AND SHAFTS THEREOF) | ⤷ Try a Trial |
Eurasian Patent Organization | 201300237 | ИНГАЛЯТОР ДЛЯ ВДЫХАНИЯ ЛЕКАРСТВЕННЫХ ВЕЩЕСТВ И СПОСОБ СБОРКИ ИНГАЛЯТОРА | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |