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Last Updated: July 5, 2020

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MAKENA PRESERVATIVE FREE Drug Profile


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When do Makena Preservative Free patents expire, and what generic alternatives are available?

Makena Preservative Free is a drug marketed by Amag Pharma Usa and is included in one NDA.

The generic ingredient in MAKENA PRESERVATIVE FREE 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 Preservative Free

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

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Summary for MAKENA PRESERVATIVE FREE
Drug patent expirations by year for MAKENA PRESERVATIVE FREE
Recent Clinical Trials for MAKENA PRESERVATIVE FREE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
AMAG Pharmaceuticals, Inc.Phase 3
AMAG Pharmaceuticals, Inc.Phase 1

See all MAKENA PRESERVATIVE FREE clinical trials

Pharmacology for MAKENA PRESERVATIVE FREE
Drug ClassProgestin

US Patents and Regulatory Information for MAKENA PRESERVATIVE FREE

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 PRESERVATIVE FREE hydroxyprogesterone caproate SOLUTION;INTRAMUSCULAR 021945-002 Feb 19, 2016 AP 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:

Baxter
Merck
Colorcon
Harvard Business School
Boehringer Ingelheim
McKesson

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