BETAMETHASONE DIPROPIONATE - Generic Drug Details
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What are the generic sources for betamethasone dipropionate and what is the scope of freedom to operate?
Betamethasone dipropionate
is the generic ingredient in thirteen branded drugs marketed by Anda Repository, Fougera Pharms, Glenmark Generics, Padagis Israel, Taro, Schering, Organon, Savage Labs, Actavis Mid Atlantic, Cosette, Perrigo New York, Pharmaderm, Teva, Zydus Pharms, Encube, Hikma, Alpharma Us Pharms, Fougera Pharms Inc, Padagis Us, Shree Hari Intl, Lupin Ltd, Tasman Pharma, Zydus Lifesciences, Primus Pharms, Glenmark Pharms Ltd, Leo Pharma As, MC2, Chartwell Rx, Glenmark Pharms, and Merck Sharp Dohme, and is included in seventy-six NDAs. There are seventeen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Betamethasone dipropionate has seven patent family members in five countries.
There are thirteen drug master file entries for betamethasone dipropionate. Twenty-four suppliers are listed for this compound.
Summary for BETAMETHASONE DIPROPIONATE
International Patents: | 7 |
US Patents: | 17 |
Tradenames: | 13 |
Applicants: | 30 |
NDAs: | 76 |
Drug Master File Entries: | 13 |
Finished Product Suppliers / Packagers: | 24 |
Raw Ingredient (Bulk) Api Vendors: | 50 |
Clinical Trials: | 65 |
Patent Applications: | 6,963 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends for BETAMETHASONE DIPROPIONATE |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for BETAMETHASONE DIPROPIONATE |
What excipients (inactive ingredients) are in BETAMETHASONE DIPROPIONATE? | BETAMETHASONE DIPROPIONATE excipients list |
DailyMed Link: | BETAMETHASONE DIPROPIONATE at DailyMed |
Recent Clinical Trials for BETAMETHASONE DIPROPIONATE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Oticara Australia PTY LTD | Phase 2 |
Affiliated Hospital of Nantong University | N/A |
Oticara Australia PTY LTD | Phase 1 |
Pharmacology for BETAMETHASONE DIPROPIONATE
Drug Class | Corticosteroid |
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Paragraph IV (Patent) Challenges for BETAMETHASONE DIPROPIONATE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
SERNIVO | Topical Spray | betamethasone dipropionate | 0.05% | 208079 | 1 | 2018-02-15 |
US Patents and Regulatory Information for BETAMETHASONE DIPROPIONATE
Expired US Patents for BETAMETHASONE DIPROPIONATE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Schering | DIPROLENE | betamethasone dipropionate | CREAM, AUGMENTED;TOPICAL | 019408-001 | Jan 31, 1986 | ⤷ Try a Trial | ⤷ Try a Trial |
Organon | DIPROLENE | betamethasone dipropionate | LOTION, AUGMENTED;TOPICAL | 019716-001 | Aug 1, 1988 | ⤷ Try a Trial | ⤷ Try a Trial |
Organon | DIPROLENE | betamethasone dipropionate | OINTMENT, AUGMENTED;TOPICAL | 018741-001 | Jul 27, 1983 | ⤷ Try a Trial | ⤷ Try a Trial |
Schering | DIPROLENE | betamethasone dipropionate | GEL, AUGMENTED;TOPICAL | 019408-002 | Nov 22, 1991 | ⤷ Try a Trial | ⤷ Try a Trial |
Schering | DIPROLENE | betamethasone dipropionate | CREAM, AUGMENTED;TOPICAL | 019408-001 | Jan 31, 1986 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for BETAMETHASONE DIPROPIONATE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
World Intellectual Property Organization (WIPO) | 2011026076 | ⤷ Try a Trial | |
Japan | 5833007 | ⤷ Try a Trial | |
European Patent Office | 2473161 | COMPOSITIONS TOPIQUES CONTENANT UN STÉROÏDE (TOPICAL FORMULATIONS COMPRISING A STEROID) | ⤷ Try a Trial |
Denmark | 2473161 | ⤷ Try a Trial | |
European Patent Office | 3141246 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
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