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 Pharms Inc, 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, Aurobindo Pharma Ltd, Lupin Ltd, Tasman Pharma, Zydus Lifesciences, Primus Pharms, Glenmark Pharms Ltd, Leo Pharma As, MC2, Chartwell Rx, Glenmark Speclt, and Merck Sharp Dohme, and is included in seventy-seven 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-five suppliers are listed for this compound.
Summary for BETAMETHASONE DIPROPIONATE
International Patents: | 7 |
US Patents: | 17 |
Tradenames: | 13 |
Applicants: | 31 |
NDAs: | 77 |
Drug Master File Entries: | 13 |
Finished Product Suppliers / Packagers: | 25 |
Raw Ingredient (Bulk) Api Vendors: | 50 |
Clinical Trials: | 66 |
Patent Applications: | 6,957 |
Drug Prices: | Drug price trends for BETAMETHASONE DIPROPIONATE |
Drug Sales Revenues: | Drug sales revenues 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 |
---|---|
Wake Forest University Health Sciences | Phase 2/Phase 3 |
Dermavant Sciences, Inc. | Phase 2/Phase 3 |
Oticara Australia PTY LTD | Phase 2 |
Pharmacology for BETAMETHASONE DIPROPIONATE
Drug Class | Corticosteroid |
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for BETAMETHASONE DIPROPIONATE
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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Chartwell Rx | CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE | betamethasone dipropionate; calcipotriene | OINTMENT;TOPICAL | 201615-001 | Jan 14, 2013 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Pharmaderm | BETAMETHASONE DIPROPIONATE | betamethasone dipropionate | CREAM;TOPICAL | 019136-001 | Jun 26, 1984 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Taro | BETAMETHASONE DIPROPIONATE | betamethasone dipropionate | CREAM;TOPICAL | 073552-001 | Apr 30, 1992 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Cosette | BETAMETHASONE DIPROPIONATE | betamethasone dipropionate | LOTION;TOPICAL | 071882-001 | Jun 6, 1988 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Shree Hari Intl | BETAMETHASONE DIPROPIONATE | betamethasone dipropionate | LOTION;TOPICAL | 070274-001 | Aug 12, 1985 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Schering | DIPROLENE | betamethasone dipropionate | GEL, AUGMENTED;TOPICAL | 019408-002 | Nov 22, 1991 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Schering | DIPROSONE | betamethasone dipropionate | LOTION;TOPICAL | 017781-001 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ 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 BETAMETHASONE DIPROPIONATE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Schering | DIPROLENE | betamethasone dipropionate | GEL, AUGMENTED;TOPICAL | 019408-002 | Nov 22, 1991 | ⤷ Sign Up | ⤷ Sign Up |
Schering | DIPROLENE | betamethasone dipropionate | CREAM, AUGMENTED;TOPICAL | 019408-001 | Jan 31, 1986 | ⤷ Sign Up | ⤷ Sign Up |
Organon | DIPROLENE AF | betamethasone dipropionate | CREAM, AUGMENTED;TOPICAL | 019555-001 | Apr 27, 1987 | ⤷ Sign Up | ⤷ Sign Up |
Organon | DIPROLENE | betamethasone dipropionate | OINTMENT, AUGMENTED;TOPICAL | 018741-001 | Jul 27, 1983 | ⤷ Sign Up | ⤷ Sign Up |
Schering | DIPROLENE | betamethasone dipropionate | CREAM, AUGMENTED;TOPICAL | 019408-001 | Jan 31, 1986 | ⤷ Sign Up | ⤷ Sign Up |
Organon | DIPROLENE | betamethasone dipropionate | LOTION, AUGMENTED;TOPICAL | 019716-001 | Aug 1, 1988 | ⤷ Sign Up | ⤷ Sign Up |
>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 | ⤷ Sign Up | |
Japan | 5833007 | ⤷ Sign Up | |
European Patent Office | 2473161 | COMPOSITIONS TOPIQUES CONTENANT UN STÉROÏDE (TOPICAL FORMULATIONS COMPRISING A STEROID) | ⤷ Sign Up |
Spain | 2637447 | ⤷ Sign Up | |
Japan | 2013503203 | ⤷ Sign Up | |
Denmark | 2473161 | ⤷ Sign Up | |
European Patent Office | 3141246 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
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