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MAKENA PRESERVATIVE FREE Drug Profile
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When do Makena Preservative Free patents expire, and what generic alternatives are available?
Makena Preservative Free is a drug marketed by Amag Pharma Usa and is included in one NDA.
The generic ingredient in MAKENA PRESERVATIVE FREE 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 Preservative Free
A generic version of MAKENA PRESERVATIVE FREE was approved as hydroxyprogesterone caproate by ASPEN GLOBAL INC on August 24th, 2015.
Summary for MAKENA PRESERVATIVE FREE
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 2 |
| Clinical Trials: | 2 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | MAKENA PRESERVATIVE FREE at DailyMed |
Recent Clinical Trials for MAKENA PRESERVATIVE FREE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| AMAG Pharmaceuticals, Inc. | Phase 3 |
| AMAG Pharmaceuticals, Inc. | Phase 1 |
Pharmacology for MAKENA PRESERVATIVE FREE
| Drug Class | Progestin |
Paragraph IV (Patent) Challenges for MAKENA PRESERVATIVE FREE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| MAKENA (AUTOINJECTOR) | SOLUTION;SUBCUTANEOUS | hydroxyprogesterone caproate | 021945 | 2020-09-28 |
| MAKENA | SOLUTION;INTRAMUSCULAR | hydroxyprogesterone caproate | 021945 | 2020-09-28 |
| MAKENA PRESERVATIVE FREE | SOLUTION;INTRAMUSCULAR | hydroxyprogesterone caproate | 021945 | 2020-09-28 |
US Patents and Regulatory Information for MAKENA PRESERVATIVE FREE
| 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 PRESERVATIVE FREE | hydroxyprogesterone caproate | SOLUTION;INTRAMUSCULAR | 021945-002 | Feb 19, 2016 | AP | 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 PRESERVATIVE FREE
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Australia | 2013203784 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2014124427 | Start Trial |
| European Patent Office | 1104317 | Start Trial |
| China | 101132820 | Start Trial |
| Japan | 2018153647 | Start Trial |
| Israel | 184765 | Start Trial |
| Hungary | E042286 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
