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Beclomethasone dipropionate - Generic Drug Details
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What are the generic sources for beclomethasone dipropionate and what is the scope of freedom to operate?
Beclomethasone dipropionate
is the generic ingredient in eleven branded drugs marketed by Glaxosmithkline, Teva Branded Pharm, Norton Waterford, and Schering, and is included in eleven NDAs. There are thirteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.Beclomethasone dipropionate has three hundred and seventeen patent family members in thirty-five countries.
There are twenty drug master file entries for beclomethasone dipropionate. Three suppliers are listed for this compound.
Summary for beclomethasone dipropionate
International Patents: | 317 |
US Patents: | 13 |
Tradenames: | 11 |
Applicants: | 4 |
NDAs: | 11 |
Drug Master File Entries: | 20 |
Suppliers / Packagers: | 3 |
Bulk Api Vendors: | 57 |
Clinical Trials: | 87 |
Patent Applications: | 6,897 |
Formulation / Manufacturing: | see details |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for beclomethasone dipropionate |
What excipients (inactive ingredients) are in beclomethasone dipropionate? | beclomethasone dipropionate excipients list |
DailyMed Link: | beclomethasone dipropionate at DailyMed |
Recent Clinical Trials for beclomethasone dipropionate
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Aurobindo Pharma Ltd | Phase 3 |
Adamis Pharmaceuticals Corporation | Phase 3 |
Amneal Ireland Limited | Phase 3 |
Pharmacology for beclomethasone dipropionate
Drug Class | Corticosteroid |
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Paragraph IV (Patent) Challenges for BECLOMETHASONE DIPROPIONATE
Tradename | Dosage | Ingredient | NDA | Submissiondate |
---|---|---|---|---|
QVAR 80 | AEROSOL, METERED;INHALATION | beclomethasone dipropionate | 020911 | 2020-01-10 |
QVAR 40 | AEROSOL, METERED;INHALATION | beclomethasone dipropionate | 020911 | 2020-01-10 |
US Patents and Regulatory Information for beclomethasone dipropionate
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 | 207921-001 | Aug 3, 2017 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
Teva Branded Pharm | QVAR 80 | beclomethasone dipropionate | AEROSOL, METERED;INHALATION | 020911-001 | Sep 15, 2000 | DISCN | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
Norton Waterford | QVAR REDIHALER | beclomethasone dipropionate | AEROSOL, METERED;INHALATION | 207921-002 | Aug 3, 2017 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
Teva Branded Pharm | QVAR 80 | beclomethasone dipropionate | AEROSOL, METERED;INHALATION | 020911-001 | Sep 15, 2000 | DISCN | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
Norton Waterford | QVAR REDIHALER | beclomethasone dipropionate | AEROSOL, METERED;INHALATION | 207921-001 | Aug 3, 2017 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
Glaxosmithkline | BECONASE | beclomethasone dipropionate | AEROSOL, METERED;NASAL | 018584-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
Teva Branded Pharm | QVAR 80 | beclomethasone dipropionate | AEROSOL, METERED;INHALATION | 020911-001 | Sep 15, 2000 | DISCN | Yes | No | Start Trial | Start Trial | Y | Start 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 beclomethasone dipropionate
International Patents for beclomethasone dipropionate
Country | Patent Number | Estimated Expiration |
---|---|---|
China | 105903111 | Start Trial |
Poland | 2627386 | Start Trial |
China | 105597205 | Start Trial |
Japan | 2014111199 | Start Trial |
Cyprus | 1116358 | Start Trial |
Spain | 2496741 | Start Trial |
Japan | 2015231585 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
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