BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE - Generic Drug Details
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What are the generic sources for betamethasone dipropionate; calcipotriene and what is the scope of freedom to operate?
Betamethasone dipropionate; calcipotriene
is the generic ingredient in five branded drugs marketed by Glenmark Pharms Ltd, Leo Pharma As, MC2, Chartwell Rx, Padagis Israel, Cosette, and Taro, and is included in ten NDAs. There are ten patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Betamethasone dipropionate; calcipotriene has eighty-four patent family members in thirty-two countries.
Seven suppliers are listed for this compound.
Summary for BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE
International Patents: | 84 |
US Patents: | 10 |
Tradenames: | 5 |
Applicants: | 7 |
NDAs: | 10 |
Finished Product Suppliers / Packagers: | 7 |
Clinical Trials: | 16 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE |
DailyMed Link: | BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE at DailyMed |
Recent Clinical Trials for BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University of Alabama at Birmingham | Phase 4 |
Eli Lilly and Company | Phase 4 |
Celgene Corporation | Phase 4 |
See all BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE clinical trials
Pharmacology for BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE
Drug Class | Corticosteroid Vitamin D Analog |
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE
Paragraph IV (Patent) Challenges for BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
ENSTILAR | Topical Foam | betamethasone dipropionate; calcipotriene | 0.005%/0.064% | 207589 | 1 | 2020-06-22 |
TACLONEX | Ointment | betamethasone dipropionate; calcipotriene | 0.005%/0.064% | 021852 | 1 | 2010-03-31 |
US Patents and Regulatory Information for BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Cosette | CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE | betamethasone dipropionate; calcipotriene | SUSPENSION;TOPICAL | 210765-001 | May 11, 2020 | AB | RX | No | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | |||
Leo Pharma As | TACLONEX | betamethasone dipropionate; calcipotriene | OINTMENT;TOPICAL | 021852-001 | Jan 9, 2006 | AB | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | |||
Leo Pharma As | ENSTILAR | betamethasone dipropionate; calcipotriene | AEROSOL, FOAM;TOPICAL | 207589-001 | Oct 16, 2015 | AB | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | Y | ⤷ Subscribe | ||
Padagis Israel | CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE | betamethasone dipropionate; calcipotriene | OINTMENT;TOPICAL | 200174-001 | Dec 12, 2014 | AB | RX | No | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | |||
Leo Pharma As | TACLONEX | betamethasone dipropionate; calcipotriene | SUSPENSION;TOPICAL | 022185-001 | May 9, 2008 | AB | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | |||
Leo Pharma As | ENSTILAR | betamethasone dipropionate; calcipotriene | AEROSOL, FOAM;TOPICAL | 207589-001 | Oct 16, 2015 | AB | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | Y | ⤷ Subscribe | ||
Glenmark Pharms Ltd | CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE | betamethasone dipropionate; calcipotriene | AEROSOL, FOAM;TOPICAL | 214688-001 | Mar 21, 2023 | AB | RX | No | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | |||
>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; CALCIPOTRIENE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Leo Pharma As | TACLONEX | betamethasone dipropionate; calcipotriene | OINTMENT;TOPICAL | 021852-001 | Jan 9, 2006 | ⤷ Subscribe | ⤷ Subscribe |
Leo Pharma As | TACLONEX | betamethasone dipropionate; calcipotriene | SUSPENSION;TOPICAL | 022185-001 | May 9, 2008 | ⤷ Subscribe | ⤷ Subscribe |
Leo Pharma As | TACLONEX | betamethasone dipropionate; calcipotriene | OINTMENT;TOPICAL | 021852-001 | Jan 9, 2006 | ⤷ Subscribe | ⤷ Subscribe |
Leo Pharma As | ENSTILAR | betamethasone dipropionate; calcipotriene | AEROSOL, FOAM;TOPICAL | 207589-001 | Oct 16, 2015 | ⤷ Subscribe | ⤷ Subscribe |
Leo Pharma As | TACLONEX | betamethasone dipropionate; calcipotriene | SUSPENSION;TOPICAL | 022185-001 | May 9, 2008 | ⤷ Subscribe | ⤷ Subscribe |
Leo Pharma As | TACLONEX | betamethasone dipropionate; calcipotriene | OINTMENT;TOPICAL | 021852-001 | Jan 9, 2006 | ⤷ Subscribe | ⤷ Subscribe |
Leo Pharma As | TACLONEX | betamethasone dipropionate; calcipotriene | SUSPENSION;TOPICAL | 022185-001 | May 9, 2008 | ⤷ Subscribe | ⤷ Subscribe |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Portugal | 3768241 | ⤷ Subscribe | |
World Intellectual Property Organization (WIPO) | 2019179958 | ⤷ Subscribe | |
Hong Kong | 1182321 | 含有維生素 類似物和皮質類固醇的藥用噴霧劑組合物 (A PHARMACEUTICAL SPRAY COMPOSITION COMPRISING A VITAMIN ANALOGUE AND A CORTICOSTEROID) | ⤷ Subscribe |
Canada | 3093999 | COMPOSITIONS TOPIQUES COMPRENANT DES DISPERSIONS DE POLYAPHRONS (TOPICAL COMPOSITIONS COMPRISING POLYAPHRON DISPERSIONS) | ⤷ Subscribe |
Poland | 3768241 | ⤷ Subscribe | |
Spain | 2529506 | ⤷ Subscribe | |
China | 111867563 | 局部组合物 (TOPICAL COMPOSITION) | ⤷ Subscribe |
>Country | >Patent Number | >Title | >Estimated Expiration |
BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE Market Analysis and Financial Projection Experimental
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