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Last Updated: February 18, 2020

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MAKENA (AUTOINJECTOR) Drug Profile


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

Makena (autoinjector) is a drug marketed by Amag Pharma Usa and is included in one NDA. There are nine patents protecting this drug.

This drug has fifty patent family members in fifteen countries.

The generic ingredient in MAKENA (AUTOINJECTOR) is hydroxyprogesterone caproate. There are twelve drug master file entries for this compound. Nine 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)
Recent Litigation for MAKENA (AUTOINJECTOR)

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District Court Litigation
Case NameDate
Antares Pharma Inc. v. Medac Pharma Inc.2014-07-21

See all MAKENA (AUTOINJECTOR) litigation

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

Baxter
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Boehringer Ingelheim
Mallinckrodt
Medtronic
AstraZeneca

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