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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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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.
ISSN: 2162-2639
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