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Last Updated: July 6, 2020

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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 Amag Pharma Usa and is included in one NDA. There are eight patents protecting this drug.

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.

US ANDA 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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Drug patent expirations by year for MAKENA (AUTOINJECTOR)
Pharmacology for MAKENA (AUTOINJECTOR)
Drug ClassProgestin

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
Amag Pharma Usa MAKENA (AUTOINJECTOR) hydroxyprogesterone caproate SOLUTION;SUBCUTANEOUS 021945-004 Feb 14, 2018 RX Yes Yes   Start Trial   Start Trial   Start Trial
Amag Pharma Usa MAKENA (AUTOINJECTOR) hydroxyprogesterone caproate SOLUTION;SUBCUTANEOUS 021945-004 Feb 14, 2018 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Amag Pharma Usa MAKENA (AUTOINJECTOR) hydroxyprogesterone caproate SOLUTION;SUBCUTANEOUS 021945-004 Feb 14, 2018 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Amag Pharma Usa MAKENA (AUTOINJECTOR) hydroxyprogesterone caproate SOLUTION;SUBCUTANEOUS 021945-004 Feb 14, 2018 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Amag Pharma Usa MAKENA (AUTOINJECTOR) hydroxyprogesterone caproate SOLUTION;SUBCUTANEOUS 021945-004 Feb 14, 2018 RX Yes Yes   Start Trial   Start Trial   Start Trial
>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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