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Boehringer Ingelheim
Dow
Johnson and Johnson
Moodys
Harvard Business School
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Last Updated: September 25, 2022

MAKENA (AUTOINJECTOR) Drug Patent Profile


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When do Makena (autoinjector) patents expire, and what generic alternatives are available?

Makena (autoinjector) is a drug marketed by Covis and is included in one NDA. There are ten patents protecting this drug and one Paragraph IV challenge.

This drug has forty-three patent family members in thirteen countries.

The generic ingredient in MAKENA (AUTOINJECTOR) 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 (autoinjector)

A generic version of MAKENA (AUTOINJECTOR) was approved as hydroxyprogesterone caproate by ASPEN GLOBAL INC on August 24th, 2015.

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Paragraph IV (Patent) Challenges for MAKENA (AUTOINJECTOR)
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
MAKENA (AUTOINJECTOR) Injection (Auto- injector) hydroxyprogesterone caproate 275 mg/1.1 mL 021945 1 2020-09-28

US Patents and Regulatory Information for MAKENA (AUTOINJECTOR)

MAKENA (AUTOINJECTOR) is protected by ten US patents.

Patents protecting MAKENA (AUTOINJECTOR)

Methods of reducing risk of preterm birth
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: REDUCING THE RISK OF PRETERM BIRTH IN WOMEN WITH A SINGLETON PREGNANCY WHO HAVE A HISTORY OF SINGLETON SPONTANEOUS PRETERM BIRTH

Methods of reducing risk of preterm birth
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: REDUCING THE RISK OF PRETERM BIRTH IN WOMEN WITH A SINGLETON PREGNANCY WHO HAVE A HISTORY OF SINGLETON SPONTANEOUS PRETERM BIRTH

Methods of reducing risk of preterm birth
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: REDUCING THE RISK OF PRETERM BIRTH IN WOMEN WITH A SINGLETON PREGNANCY WHO HAVE A HISTORY OF SINGLETON SPONTANEOUS PRETERM BIRTH

Prefilled syringe jet injector
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Prefilled syringe jet injector
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Prefilled syringe jet injector
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Prefilled syringe jet injector
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Prefilled syringe jet injector
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Needle assisted injection device having reduced trigger force
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Methods of reducing risk of preterm birth
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: REDUCING THE RISK OF PRETERM BIRTH IN WOMEN WITH A SINGLETON PREGNANCY WHO HAVE A HISTORY OF SINGLETON SPONTANEOUS PRETERM BIRTH

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
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 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 (AUTOINJECTOR)

See the table below for patents covering MAKENA (AUTOINJECTOR) around the world.

Country Patent Number Title Estimated Expiration
Japan 2018153647 トリガ力を低減した針支援式ジェット注射装置 (NEEDLE SUPPORT TYPE JET INJECTION DEVICE REDUCED IN TRIGGER FORCE) See Plans and Pricing
Canada 2900672 DISPOSITIF D'INJECTION A JET ASSISTEE PAR AIGUILLE AYANT UNE FORCE DE DECLENCHEMENT REDUITE (NEEDLE ASSISTED JET INJECTION DEVICE HAVING REDUCED TRIGGER FORCE) See Plans and Pricing
World Intellectual Property Organization (WIPO) 2013169800 See Plans and Pricing
China 1323230 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

McKesson
Boehringer Ingelheim
Express Scripts
Johnson and Johnson
Baxter
Harvard Business School

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.