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Hydroxyprogesterone caproate - Generic Drug Details
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What are the generic sources for hydroxyprogesterone caproate and what is the scope of patent protection?
Hydroxyprogesterone caproate
is 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
International Patents: | 42 |
US Patents: | 8 |
Tradenames: | 5 |
Applicants: | 10 |
NDAs: | 15 |
Drug Master File Entries: | 12 |
Suppliers / Packagers: | 7 |
Bulk Api Vendors: | 66 |
Clinical Trials: | 27 |
Patent Applications: | 6,954 |
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 |
What excipients (inactive ingredients) are in hydroxyprogesterone caproate? | hydroxyprogesterone caproate excipients list |
DailyMed Link: | hydroxyprogesterone caproate at DailyMed |
Recent Clinical Trials for hydroxyprogesterone caproate
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Assiut University | Phase 4 |
Aswan University Hospital | N/A |
University of North Carolina, Chapel Hill | Phase 3 |
Pharmacology for hydroxyprogesterone caproate
Drug Class | Progestin |
Paragraph IV (Patent) Challenges for HYDROXYPROGESTERONE CAPROATE
Tradename | Dosage | Ingredient | NDA | Submissiondate |
---|---|---|---|---|
MAKENA | SOLUTION;INTRAMUSCULAR | hydroxyprogesterone caproate | 021945 | 2020-09-28 |
MAKENA PRESERVATIVE FREE | SOLUTION;INTRAMUSCULAR | hydroxyprogesterone caproate | 021945 | 2020-09-28 |
MAKENA (AUTOINJECTOR) | SOLUTION;SUBCUTANEOUS | hydroxyprogesterone caproate | 021945 | 2020-09-28 |
US Patents and Regulatory Information for hydroxyprogesterone caproate
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Aspen Global Inc | HYDROXYPROGESTERONE CAPROATE | hydroxyprogesterone caproate | SOLUTION;INTRAMUSCULAR | 200271-001 | Aug 24, 2015 | RX | No | Yes | Start Trial | Start Trial | Start Trial | ||||
Bristol Myers Squibb | DELALUTIN | hydroxyprogesterone caproate | SOLUTION;INTRAMUSCULAR | 010347-002 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | Start Trial | Start Trial | Start Trial | ||||
Bristol Myers Squibb | DELALUTIN | hydroxyprogesterone caproate | SOLUTION;INTRAMUSCULAR | 016911-001 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | Start Trial | Start Trial | Start Trial | ||||
Bristol Myers Squibb | DELALUTIN | hydroxyprogesterone caproate | SOLUTION;INTRAMUSCULAR | 016911-002 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | Start Trial | Start Trial | Start Trial | ||||
Sun Pharm | HYDROXYPROGESTERONE CAPROATE | hydroxyprogesterone caproate | SOLUTION;INTRAMUSCULAR | 208381-001 | Apr 9, 2019 | AP1 | RX | No | 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 hydroxyprogesterone caproate
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 |
International Patents for hydroxyprogesterone caproate
Country | Patent Number | Estimated Expiration |
---|---|---|
Hungary | E042286 | Start Trial |
Denmark | 1850892 | Start Trial |
Japan | 6457383 | Start Trial |
European Patent Office | 1850892 | Start Trial |
Denmark | 2953667 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
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