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Last Updated: March 19, 2024

Betamethasone dipropionate; calcipotriene - Generic Drug Details


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What are the generic drug sources for betamethasone dipropionate; calcipotriene and what is the scope of patent protection?

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
Recent Clinical Trials for betamethasone dipropionate; calcipotriene

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of Alabama at BirminghamPhase 4
Eli Lilly and CompanyPhase 4
Celgene CorporationPhase 4

See all betamethasone dipropionate; calcipotriene clinical trials

Pharmacology 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
Mc2 WYNZORA betamethasone dipropionate; calcipotriene CREAM;TOPICAL 213422-001 Jul 20, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Leo Pharma As ENSTILAR betamethasone dipropionate; calcipotriene AEROSOL, FOAM;TOPICAL 207589-001 Oct 16, 2015 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Leo Pharma As ENSTILAR betamethasone dipropionate; calcipotriene AEROSOL, FOAM;TOPICAL 207589-001 Oct 16, 2015 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Mc2 WYNZORA betamethasone dipropionate; calcipotriene CREAM;TOPICAL 213422-001 Jul 20, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Leo Pharma As ENSTILAR betamethasone dipropionate; calcipotriene AEROSOL, FOAM;TOPICAL 207589-001 Oct 16, 2015 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Taro CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE betamethasone dipropionate; calcipotriene SUSPENSION;TOPICAL 213269-001 Sep 2, 2020 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Leo Pharma As TACLONEX betamethasone dipropionate; calcipotriene SUSPENSION;TOPICAL 022185-001 May 9, 2008 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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 betamethasone dipropionate; calcipotriene

International Patents for betamethasone dipropionate; calcipotriene

Country Patent Number Title Estimated Expiration
South Africa 200906382 POLYAPHRON TOPICAL COMPOSITION WITH VITAMIN D AND CORTICOTEROID ⤷  Try a Trial
South Korea 20230172042 국소 조성물 (TOPICAL COMPOSITION) ⤷  Try a Trial
South Africa 201208281 A PHARMACEUTICAL SPRAY COMPOSITION COMPRISING A VITAMIN D ANALOGUE AND A CORTICOSTEROID ⤷  Try a Trial
Mexico 2020009764 COMPOSICION TOPICA. (TOPICAL COMPOSITION.) ⤷  Try a Trial
Mexico 2012013591 COMPOSICION FARMACEUTICA EN AEROSOL QUE COMPRENDE ANALOGO DE VITAMINA D Y CORTICOSTEROIDE. (A PHARMACEUTICAL SPRAY COMPOSITION COMPRISING A VITAMIN D ANALOGUE AND A CORTICOSTEROID.) ⤷  Try a Trial
China 104815329 Polyaphron topical composition with vitamin D and corticosteroid, application and manufacturing method thereof ⤷  Try a Trial
European Patent Office 2579852 COMPOSITION PHARMACEUTIQUE PULVERISABLE COMPRENANT UN VITAMINE D ANALOGUE ET UN COTICOSTEROID (A PHARMACEUTICAL SPRAY COMPOSITION COMPRISING A VITAMIN D ANALOGUE AND A CORTICOSTEROID) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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