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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, 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.
Summary for calcipotriene
| International Patents: | 28 |
| US Patents: | 2 |
| Tradenames: | 3 |
| Applicants: | 10 |
| NDAs: | 12 |
| Drug Master File Entries: | 12 |
| Suppliers / Packagers: | 14 |
| Bulk Api Vendors: | 42 |
| Clinical Trials: | 30 |
| Patent Applications: | 4,629 |
| Drug Prices: | Drug price trends for calcipotriene |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for calcipotriene |
| DailyMed Link: | calcipotriene at DailyMed |
Recent Clinical Trials for calcipotriene
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Alabama at Birmingham | Phase 4 |
| Eli Lilly and Company | Phase 4 |
| Mayne Pharma International Pty Ltd | Early Phase 1 |
Pharmacology for calcipotriene
| Drug Class | Vitamin D Analog |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Cosette | CALCIPOTRIENE | calcipotriene | SOLUTION;TOPICAL | 078468-001 | Mar 24, 2011 | AT | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Fougera Pharms | CALCIPOTRIENE | calcipotriene | SOLUTION;TOPICAL | 078305-001 | May 6, 2008 | AT | 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 | ||||
| Mayne Pharma | SORILUX | calcipotriene | AEROSOL, FOAM;TOPICAL | 022563-001 | Oct 6, 2010 | RX | Yes | Yes | Start Trial | Start Trial | Y | 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 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 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 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for calcipotriene
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | 4603164 | Start Trial |
| European Patent Office | 1917072 | Start Trial |
| Poland | 2526930 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2006129161 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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