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Last Updated: August 8, 2022

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.

Drug patent expirations by year for MAKENA
Drug Prices for MAKENA

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Recent Clinical Trials for MAKENA

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Thomas Jefferson UniversityPhase 4
George Washington UniversityPhase 4
Vriginia Commonwealth UniversityPhase 4

See all MAKENA clinical trials

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
Covis MAKENA hydroxyprogesterone caproate SOLUTION;INTRAMUSCULAR 021945-001 Feb 3, 2011 AP1 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Covis MAKENA (AUTOINJECTOR) hydroxyprogesterone caproate SOLUTION;SUBCUTANEOUS 021945-004 Feb 14, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Covis MAKENA (AUTOINJECTOR) hydroxyprogesterone caproate SOLUTION;SUBCUTANEOUS 021945-004 Feb 14, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Covis MAKENA PRESERVATIVE FREE hydroxyprogesterone caproate SOLUTION;INTRAMUSCULAR 021945-002 Feb 19, 2016 AP RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Covis MAKENA (AUTOINJECTOR) hydroxyprogesterone caproate SOLUTION;SUBCUTANEOUS 021945-004 Feb 14, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Covis MAKENA (AUTOINJECTOR) hydroxyprogesterone caproate SOLUTION;SUBCUTANEOUS 021945-004 Feb 14, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Covis MAKENA (AUTOINJECTOR) hydroxyprogesterone caproate SOLUTION;SUBCUTANEOUS 021945-004 Feb 14, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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

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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Serving leading biopharmaceutical companies globally:

McKinsey
Harvard Business School
Moodys
Johnson and Johnson
Boehringer Ingelheim
Colorcon

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.