Calcipotriene - Generic Drug Details
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What are the generic drug sources for calcipotriene and what is the scope of patent protection?
Calcipotriene
is the generic ingredient in three branded drugs marketed by Mayne Pharma, Glenmark Pharms, Tolmar, Leo Pharma As, Glenmark Pharms Inc, Akorn, Cosette, Fougera Pharms, 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. Fifteen suppliers are listed for this compound.
Summary for calcipotriene
International Patents: | 28 |
US Patents: | 2 |
Tradenames: | 3 |
Applicants: | 10 |
NDAs: | 12 |
Drug Master File Entries: | 12 |
Finished Product Suppliers / Packagers: | 15 |
Raw Ingredient (Bulk) Api Vendors: | 49 |
Clinical Trials: | 37 |
Patent Applications: | 7,798 |
Drug Prices: | Drug price trends for calcipotriene |
What excipients (inactive ingredients) are in calcipotriene? | calcipotriene excipients list |
DailyMed Link: | calcipotriene at DailyMed |
Recent Clinical Trials for calcipotriene
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Boston University | Phase 2/Phase 3 |
University of Alabama at Birmingham | Phase 4 |
Carilion Clinic | Early Phase 1 |
Pharmacology for calcipotriene
Drug Class | Vitamin 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Leo Pharma As | DOVONEX | calcipotriene | OINTMENT;TOPICAL | 020273-001 | Dec 29, 1993 | AB | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
Mayne Pharma | SORILUX | calcipotriene | AEROSOL, FOAM;TOPICAL | 022563-001 | Oct 6, 2010 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
Mayne Pharma | SORILUX | calcipotriene | AEROSOL, FOAM;TOPICAL | 022563-001 | Oct 6, 2010 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
Fougera Pharms | CALCIPOTRIENE | calcipotriene | SOLUTION;TOPICAL | 078305-001 | May 6, 2008 | AT | RX | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
>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 | See Plans and Pricing | See Plans and Pricing |
Leo Pharm | DOVONEX | calcipotriene | SOLUTION;TOPICAL | 020611-001 | Mar 3, 1997 | See Plans and Pricing | See Plans and Pricing |
Leo Pharm | DOVONEX | calcipotriene | SOLUTION;TOPICAL | 020611-001 | Mar 3, 1997 | See Plans and Pricing | See Plans and Pricing |
Leo Pharm | DOVONEX | calcipotriene | SOLUTION;TOPICAL | 020611-001 | Mar 3, 1997 | See Plans and Pricing | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for calcipotriene
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Spain | 2431330 | See Plans and Pricing | |
New Zealand | 508259 | Mousse composition | See Plans and Pricing |
Brazil | 9913154 | Composição de musse | See Plans and Pricing |
Australia | 2006253913 | Vitamin formulation | See Plans and Pricing |
>Country | >Patent Number | >Title | >Estimated Expiration |
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