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 sixteen patents protecting this drug and one Paragraph IV challenge.
This drug has two hundred and seventy-four 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 seven 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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Summary for QVAR REDIHALER
| International Patents: | 274 |
| US Patents: | 16 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 3 |
| Clinical Trials: | 1 |
| 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
*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 sixteen US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of QVAR REDIHALER is ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Dose counters for inhalers, inhalers and methods of assembly thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Dose counter for inhaler and method for counting doses
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Dose counter for inhaler having an anti-reverse rotation actuator
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Dose counter for inhaler having an anti-reverse rotation actuator
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Breath actuated inhaler
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Inhalers and related methods
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Dose counter for inhaler having an anti-reverse rotation actuator
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Metered-dose inhaler
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Inhaler
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
| 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 | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Norton Waterford | QVAR REDIHALER | beclomethasone dipropionate | AEROSOL, METERED;INHALATION | 207921-002 | Aug 3, 2017 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Norton Waterford | QVAR REDIHALER | beclomethasone dipropionate | AEROSOL, METERED;INHALATION | 207921-002 | Aug 3, 2017 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| >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 | 207921-001 | Aug 3, 2017 | ⤷ Sign Up | ⤷ Sign Up |
| Norton Waterford | QVAR REDIHALER | beclomethasone dipropionate | AEROSOL, METERED;INHALATION | 207921-002 | Aug 3, 2017 | ⤷ Sign Up | ⤷ Sign Up |
| Norton Waterford | QVAR REDIHALER | beclomethasone dipropionate | AEROSOL, METERED;INHALATION | 207921-002 | Aug 3, 2017 | ⤷ Sign Up | ⤷ Sign Up |
| >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
Patent: Metered-dose inhaler
Estimated Expiration: ⤷ Sign Up
Austria
Patent: 56386
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 0809477
Patent: INALADOR COM DOSADOR
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 82528
Patent: INHALATEUR A MESURE DE DOSES (METERED-DOSE INHALER)
Estimated Expiration: ⤷ Sign Up
China
Patent: 1657829
Patent: Metered-dose inhaler
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 35199
Estimated Expiration: ⤷ Sign Up
Eurasian Patent Organization
Patent: 6831
Patent: ДОЗИРУЮЩИЙ ИНГАЛЯТОР (METERED-DOSE INHALER)
Estimated Expiration: ⤷ Sign Up
Patent: 0970907
Patent: ДОЗИРУЮЩИЙ ИНГАЛЯТОР
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 35199
Patent: INHALATEUR À MESURE DE DOSES (METERED-DOSE INHALER)
Estimated Expiration: ⤷ Sign Up
Hong Kong
Patent: 41349
Patent: METERED-DOSE INHALER
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 1256
Patent: מונה מנות למשאף מנה מדודה (Dose counter for metered-dose inhaler)
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 46968
Estimated Expiration: ⤷ Sign Up
Patent: 10523184
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 09010600
Patent: INHALADOR DE DOSIS MEDIDAS. (METERED-DOSE INHALER.)
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 35199
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 1475968
Estimated Expiration: ⤷ Sign Up
Patent: 090127376
Patent: METERED-DOSE INHALER
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 04818
Estimated Expiration: ⤷ Sign Up
United Kingdom
Patent: 06999
Estimated Expiration: ⤷ Sign Up
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 |
|---|---|---|---|
| Hong Kong | 1219067 | 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) | ⤷ Sign Up |
| Canada | 3111537 | COMPTEURS DE DOSES POUR INHALATEURS, INHALATEURS ET TIGES ASSOCIEES (DOSE COUNTERS FOR INHALERS, INHALERS AND SHAFTS THEREOF) | ⤷ Sign Up |
| Eurasian Patent Organization | 032332 | СЧЕТЧИК ДОЗ ДЛЯ ИНГАЛЯТОРА И ИНГАЛЯТОР, СОДЕРЖАЩИЙ СЧЕТЧИК ДОЗ (DOSE COUNTER FOR AN INHALER AND INHALER COMPRISING A DOSE COUNTER) | ⤷ Sign Up |
| >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.
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