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MAKENA Drug Profile
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» See Plans and PricingWhich patents cover Makena, and when can generic versions of Makena launch?
Makena is a drug marketed by Amag Pharma Usa and is included in one NDA. There are eight patents protecting this drug.
The generic ingredient in MAKENA is hydroxyprogesterone caproate. There are twelve drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the hydroxyprogesterone caproate profile page.
US ANDA Litigation and Generic Entry Outlook for Makena
A generic version of MAKENA was approved as hydroxyprogesterone caproate by ASPEN GLOBAL INC on August 24th, 2015.
Summary for MAKENA
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 62 |
| Clinical Trials: | 6 |
| Patent Applications: | 3,457 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for MAKENA |
| DailyMed Link: | MAKENA at DailyMed |
Recent Clinical Trials for MAKENA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| AMAG Pharmaceuticals, Inc. | Phase 1 |
| George Washington University | Phase 4 |
| Thomas Jefferson University | Phase 4 |
Pharmacology for MAKENA
| Drug Class | Progestin |
US Patents and Regulatory Information for MAKENA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Amag Pharma Usa | MAKENA | hydroxyprogesterone caproate | SOLUTION;INTRAMUSCULAR | 021945-001 | Feb 3, 2011 | AP1 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
| Amag Pharma Usa | MAKENA (AUTOINJECTOR) | hydroxyprogesterone caproate | SOLUTION;SUBCUTANEOUS | 021945-004 | Feb 14, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Amag Pharma Usa | MAKENA (AUTOINJECTOR) | hydroxyprogesterone caproate | SOLUTION;SUBCUTANEOUS | 021945-004 | Feb 14, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Amag Pharma Usa | MAKENA (AUTOINJECTOR) | hydroxyprogesterone caproate | SOLUTION;SUBCUTANEOUS | 021945-004 | Feb 14, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Amag Pharma Usa | MAKENA (AUTOINJECTOR) | hydroxyprogesterone caproate | SOLUTION;SUBCUTANEOUS | 021945-004 | Feb 14, 2018 | RX | Yes | Yes | 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 |
International Patents for MAKENA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | 4299466 | Start Trial |
| Canada | 2595730 | Start Trial |
| European Patent Office | 2833944 | Start Trial |
| Australia | 2013203784 | Start Trial |
| Portugal | 2953667 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
