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Last Updated: August 10, 2020

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Calcipotriene - Generic Drug Details

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What are the generic 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, Glenmark Pharms, Tolmar, Leo Pharma As, Glenmark Pharms Inc, Cosette, Fougera Pharms, Hi Tech Pharma, Novel Labs Inc, 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-eight patent family members in thirteen countries.

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

Drug Prices for calcipotriene

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Recent Clinical Trials for calcipotriene

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

SponsorPhase
University of Alabama at BirminghamPhase 4
Eli Lilly and CompanyPhase 4
Mayne Pharma International Pty LtdEarly Phase 1

See all calcipotriene clinical trials

Pharmacology for calcipotriene
Paragraph IV (Patent) Challenges for CALCIPOTRIENE
Tradename Dosage Ingredient NDA Submissiondate
DOVONEX CREAM;TOPICAL calcipotriene 020554 2009-12-02
DOVONEX SOLUTION;TOPICAL calcipotriene 020611 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
Fougera Pharms CALCIPOTRIENE calcipotriene SOLUTION;TOPICAL 078305-001 May 6, 2008 AT RX No No   Start Trial   Start Trial   Start Trial
Glenmark Pharms CALCIPOTRIENE calcipotriene CREAM;TOPICAL 205772-001 Jun 9, 2015 AB RX No No   Start Trial   Start Trial   Start Trial
Leo Pharm DOVONEX calcipotriene SOLUTION;TOPICAL 020611-001 Mar 3, 1997 DISCN Yes No   Start Trial   Start Trial   Start Trial
Glenmark Pharms Inc CALCIPOTRIENE calcipotriene OINTMENT;TOPICAL 090633-001 Mar 24, 2010 RX No Yes   Start Trial   Start Trial   Start Trial
Mayne Pharma SORILUX calcipotriene AEROSOL, FOAM;TOPICAL 022563-001 Oct 6, 2010 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Hi Tech Pharma CALCIPOTRIENE calcipotriene SOLUTION;TOPICAL 077579-001 Nov 19, 2009 AT RX No No   Start Trial   Start Trial   Start Trial
Leo Pharma As DOVONEX calcipotriene OINTMENT;TOPICAL 020273-001 Dec 29, 1993 DISCN Yes No   Start Trial   Start Trial   Start 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 calcipotriene

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

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