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Last Updated: November 22, 2024

CALCIPOTRIENE - Generic Drug Details


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What are the generic drug sources for calcipotriene and what is the scope of freedom to operate?

Calcipotriene is the generic ingredient in three branded drugs marketed by Mayne Pharma, Chartwell Rx, Glenmark Speclt, Leo Pharma As, Glenmark Pharms Inc, Cosette, Fougera Pharms, Hikma, and Leo Pharm, and is included in twelve NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Calcipotriene has twenty-nine patent family members in thirteen countries.

There are twelve drug master file entries for calcipotriene. Eight suppliers are listed for this compound.

Summary for CALCIPOTRIENE
International Patents:29
US Patents:2
Tradenames:3
Applicants:9
NDAs:12
Drug Master File Entries: 12
Finished Product Suppliers / Packagers: 8
Raw Ingredient (Bulk) Api Vendors: 51
Clinical Trials: 38
Patent Applications: 7,069
Drug Prices: Drug price trends for CALCIPOTRIENE
What excipients (inactive ingredients) are in CALCIPOTRIENE?CALCIPOTRIENE excipients list
DailyMed Link:CALCIPOTRIENE at DailyMed
Drug Prices for CALCIPOTRIENE

See drug prices for CALCIPOTRIENE

Recent Clinical Trials for CALCIPOTRIENE

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

SponsorPhase
National Cancer Institute (NCI)Phase 2
Boston UniversityPhase 2/Phase 3
University of Alabama at BirminghamPhase 4

See all CALCIPOTRIENE clinical trials

Pharmacology for CALCIPOTRIENE
Drug ClassVitamin D Analog
Paragraph IV (Patent) Challenges for CALCIPOTRIENE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
DOVONEX Topical Cream calcipotriene 0.005% 020554 1 2009-12-02
DOVONEX Topical Solution calcipotriene 0.005% 020611 1 2006-05-19

US Patents and Regulatory Information for CALCIPOTRIENE

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 calcipotriene SOLUTION;TOPICAL 077029-001 Nov 20, 2009 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Leo Pharm DOVONEX calcipotriene SOLUTION;TOPICAL 020611-001 Mar 3, 1997 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Cosette CALCIPOTRIENE calcipotriene SOLUTION;TOPICAL 078468-001 Mar 24, 2011 AT RX No Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Glenmark Pharms Inc CALCIPOTRIENE calcipotriene OINTMENT;TOPICAL 090633-001 Mar 24, 2010 AB RX No Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Hikma CALCIPOTRIENE calcipotriene SOLUTION;TOPICAL 077579-001 Nov 19, 2009 DISCN No 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 CALCIPOTRIENE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Leo Pharma As DOVONEX calcipotriene CREAM;TOPICAL 020554-001 Jul 22, 1996 ⤷  Sign Up ⤷  Sign Up
Leo Pharma As DOVONEX calcipotriene OINTMENT;TOPICAL 020273-001 Dec 29, 1993 ⤷  Sign Up ⤷  Sign Up
Leo Pharm DOVONEX calcipotriene SOLUTION;TOPICAL 020611-001 Mar 3, 1997 ⤷  Sign Up ⤷  Sign Up
Leo Pharm DOVONEX calcipotriene SOLUTION;TOPICAL 020611-001 Mar 3, 1997 ⤷  Sign Up ⤷  Sign Up
Leo Pharm DOVONEX calcipotriene SOLUTION;TOPICAL 020611-001 Mar 3, 1997 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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