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Hydroxyprogesterone caproateis the generic ingredient in five branded drugs marketed by Akorn, Allergan, Bristol Myers Squibb, Am Regent, Aspen, Aspen Global Inc, Eugia Pharma, Slayback Pharma Llc, Sun Pharm, and Amag Pharma Usa, and is included in fifteen NDAs. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.
Hydroxyprogesterone caproate has forty-two patent family members in thirteen countries.
There are twelve drug master file entries for hydroxyprogesterone caproate. Seven suppliers are listed for this compound.
Summary for hydroxyprogesterone caproate
|Drug Master File Entries:||12|
|Suppliers / Packagers:||7|
|Bulk Api Vendors:||62|
|Formulation / Manufacturing:||see details|
|Drug Prices:||Drug price trends for hydroxyprogesterone caproate|
|Patent Litigation and PTAB cases:||See patent lawsuits and PTAB cases for hydroxyprogesterone caproate|
|DailyMed Link:||hydroxyprogesterone caproate at DailyMed|
Recent Clinical Trials for hydroxyprogesterone caproate
Identify potential brand extensions & 505(b)(2) entrants
|Assiut University||Phase 4|
|Aswan University Hospital||N/A|
|University of North Carolina, Chapel Hill||Phase 3|
Pharmacology for hydroxyprogesterone caproate
|Drug Class||Progestin |
|Applicant||Tradename||Generic Name||Dosage||NDA||Approval Date||Patent No.||Patent Expiration|
|Amag Pharma Usa||MAKENA (AUTOINJECTOR)||hydroxyprogesterone caproate||SOLUTION;SUBCUTANEOUS||021945-004||Feb 14, 2018||Start Trial||Start Trial|
|>Applicant||>Tradename||>Generic Name||>Dosage||>NDA||>Approval Date||>Patent No.||>Patent Expiration|
|Country||Patent Number||Estimated Expiration|
|South Korea||20070117543||Start Trial|
|European Patent Office||2731645||Start Trial|
|World Intellectual Property Organization (WIPO)||2014124427||Start Trial|
|World Intellectual Property Organization (WIPO)||2014124464||Start Trial|
|>Country||>Patent Number||>Estimated Expiration|
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