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Last Updated: July 12, 2020

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MAKENA Drug Profile


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Which patents cover Makena, and when can generic versions of Makena launch?

Makena is a drug marketed by Amag Pharma Usa and is included in one NDA. There are eight 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

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SponsorPhase
AMAG Pharmaceuticals, Inc.Phase 1
George Washington UniversityPhase 4
Thomas Jefferson UniversityPhase 4

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Pharmacology for MAKENA
Drug ClassProgestin

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
Amag Pharma Usa MAKENA hydroxyprogesterone caproate SOLUTION;INTRAMUSCULAR 021945-001 Feb 3, 2011 AP1 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:

McKinsey
Harvard Business School
Moodys
Johnson and Johnson
Boehringer Ingelheim
Colorcon

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