By tracking patent expirations, patent litigation, generic and biosimilar development, you can anticipate these market-shaping forces and stay one step ahead.
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MAKENA Drug Profile
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Which patents cover Makena, and when can generic versions of Makena launch?
Makena is a drug marketed by Covis and is included in one NDA. There are eight patents protecting this drug and one Paragraph IV challenge.
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.
DrugPatentWatch® 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 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 66 |
| Clinical Trials: | 6 |
| Patent Applications: | 4,242 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for MAKENA |
| What excipients (inactive ingredients) are in MAKENA? | MAKENA excipients list |
| 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 |
ATC Classes for MAKENA
Paragraph IV (Patent) Challenges for MAKENA
| 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 MAKENA
International Patents for MAKENA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| South Korea | 20150011346 | Get Started Free |
| China | 101132820 | Get Started Free |
| European Patent Office | 2953667 | Get Started Free |
| European Patent Office | 2833944 | Get Started Free |
| Australia | 2013203784 | Get Started Free |
| China | 1323230 | Get Started Free |
| Japan | 2016507305 | Get Started Free |
| >Country | >Patent Number | >Estimated Expiration |
