MAKENA Drug Patent 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 ten 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.
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: | 68 |
| Clinical Trials: | 6 |
| Patent Applications: | 5,492 |
| 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 |
|---|---|
| Thomas Jefferson University | Phase 4 |
| George Washington University | Phase 4 |
| Vriginia Commonwealth University | Phase 4 |
Pharmacology for MAKENA
| Drug Class | Progestin |
Anatomical Therapeutic Chemical (ATC) Classes for MAKENA
US Patents and Regulatory Information for MAKENA
International Patents for MAKENA
See the table below for patents covering MAKENA around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Japan | 2008528126 | See Plans and Pricing | |
| World Intellectual Property Organization (WIPO) | 2006079064 | See Plans and Pricing | |
| World Intellectual Property Organization (WIPO) | 2013152323 | See Plans and Pricing | |
| Japan | 2017080424 | トリガ力を低減した針支援式ジェット注射装置 (NEEDLE ASSISTED JET INJECTION DEVICE HAVING REDUCED TRIGGER FORCE) | See Plans and Pricing |
| Canada | 2868500 | ADMINISTRATION PAR INJECTION PAR JET ASSISTEE PAR UNE AIGUILLE DE COMPOSITIONS DE TESTOSTERONE (NEEDLE ASSISTED JET INJECTION ADMINISTRATION OF TESTOSTERONE COMPOSITIONS) | See Plans and Pricing |
| Spain | 2763633 | See Plans and Pricing | |
| World Intellectual Property Organization (WIPO) | 2014124464 | See Plans and Pricing | |
| >Country | >Patent Number | >Title | >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.
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Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2022, www.DrugPatentWatch.com.
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