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.
Eight 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: | 8 |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Leo Pharma As | TACLONEX | betamethasone dipropionate; calcipotriene | OINTMENT;TOPICAL | 021852-001 | Jan 9, 2006 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Taro | CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE | betamethasone dipropionate; calcipotriene | SUSPENSION;TOPICAL | 213269-001 | Sep 2, 2020 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Leo Pharma As | ENSTILAR | betamethasone dipropionate; calcipotriene | AEROSOL, FOAM;TOPICAL | 207589-001 | Oct 16, 2015 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
Mc2 | WYNZORA | betamethasone dipropionate; calcipotriene | CREAM;TOPICAL | 213422-001 | Jul 20, 2020 | RX | Yes | Yes | ⤷ 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 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 | ⤷ Sign Up | ⤷ Sign Up |
Leo Pharma As | ENSTILAR | betamethasone dipropionate; calcipotriene | AEROSOL, FOAM;TOPICAL | 207589-001 | Oct 16, 2015 | ⤷ Sign Up | ⤷ Sign Up |
Leo Pharma As | TACLONEX | betamethasone dipropionate; calcipotriene | SUSPENSION;TOPICAL | 022185-001 | May 9, 2008 | ⤷ Sign Up | ⤷ Sign Up |
Leo Pharma As | TACLONEX | betamethasone dipropionate; calcipotriene | OINTMENT;TOPICAL | 021852-001 | Jan 9, 2006 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
China | 111867563 | 局部组合物 (TOPICAL COMPOSITION) | ⤷ Sign Up |
Singapore | 11202008698Q | TOPICAL COMPOSITION | ⤷ Sign Up |
Spain | 2529506 | ⤷ Sign Up | |
Croatia | P20150154 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
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