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Last Updated: June 24, 2021

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MAKENA (AUTOINJECTOR) Drug 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 eight patents protecting this drug and one Paragraph IV challenge.

This drug has forty-two 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.

Paragraph IV (Patent) Challenges for MAKENA (AUTOINJECTOR)
Tradename Dosage Ingredient NDA Submissiondate
MAKENA PRESERVATIVE FREE SOLUTION;INTRAMUSCULAR hydroxyprogesterone caproate 021945 2020-09-28
MAKENA (AUTOINJECTOR) SOLUTION;SUBCUTANEOUS hydroxyprogesterone caproate 021945 2020-09-28
MAKENA SOLUTION;INTRAMUSCULAR hydroxyprogesterone caproate 021945 2020-09-28

US Patents and Regulatory Information for MAKENA (AUTOINJECTOR)

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   Try Before You Buy   Try Before You Buy   Try Before You Buy
Covis MAKENA (AUTOINJECTOR) hydroxyprogesterone caproate SOLUTION;SUBCUTANEOUS 021945-004 Feb 14, 2018 RX Yes Yes   Try Before You Buy   Try Before You Buy Y   Try Before You Buy
Covis MAKENA (AUTOINJECTOR) hydroxyprogesterone caproate SOLUTION;SUBCUTANEOUS 021945-004 Feb 14, 2018 RX Yes Yes   Try Before You Buy   Try Before You Buy Y   Try Before You Buy
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

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

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