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 |
Recent Clinical Trials for CALCIPOTRIENE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
National Cancer Institute (NCI) | Phase 2 |
Boston University | Phase 2/Phase 3 |
University of Alabama at Birmingham | Phase 4 |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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 |
International Patents for CALCIPOTRIENE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Germany | 69937802 | ⤷ Sign Up | |
Japan | 2002524490 | ⤷ Sign Up | |
Spain | 2447301 | ⤷ Sign Up | |
Spain | 2431330 | ⤷ Sign Up | |
Poland | 1917072 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
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