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Last Updated: March 8, 2021

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Hydroxyprogesterone caproate - Generic Drug Details

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What are the generic sources for hydroxyprogesterone caproate and what is the scope of patent protection?

Hydroxyprogesterone caproate is the generic ingredient in five branded drugs marketed by Akorn, Allergan, Bristol Myers Squibb, Am Regent, Aspen, Aspen Global Inc, Eugia Pharma, Slayback Pharma Llc, Sun Pharm, and Amag Pharma Usa, and is included in fifteen NDAs. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Hydroxyprogesterone caproate has forty-two patent family members in thirteen countries.

There are twelve drug master file entries for hydroxyprogesterone caproate. Seven suppliers are listed for this compound.

Drug Prices for hydroxyprogesterone caproate

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Recent Clinical Trials for hydroxyprogesterone caproate

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

SponsorPhase
Assiut UniversityPhase 4
Aswan University HospitalN/A
University of North Carolina, Chapel HillPhase 3

See all hydroxyprogesterone caproate clinical trials

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

US Patents and Regulatory Information for hydroxyprogesterone caproate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Aspen Global Inc HYDROXYPROGESTERONE CAPROATE hydroxyprogesterone caproate SOLUTION;INTRAMUSCULAR 200271-001 Aug 24, 2015 RX No Yes   Start Trial   Start Trial   Start Trial
Bristol Myers Squibb DELALUTIN hydroxyprogesterone caproate SOLUTION;INTRAMUSCULAR 010347-002 Approved Prior to Jan 1, 1982 DISCN Yes No   Start Trial   Start Trial   Start Trial
Bristol Myers Squibb DELALUTIN hydroxyprogesterone caproate SOLUTION;INTRAMUSCULAR 016911-001 Approved Prior to Jan 1, 1982 DISCN Yes No   Start Trial   Start Trial   Start Trial
Bristol Myers Squibb DELALUTIN hydroxyprogesterone caproate SOLUTION;INTRAMUSCULAR 016911-002 Approved Prior to Jan 1, 1982 DISCN Yes No   Start Trial   Start Trial   Start Trial
Sun Pharm HYDROXYPROGESTERONE CAPROATE hydroxyprogesterone caproate SOLUTION;INTRAMUSCULAR 208381-001 Apr 9, 2019 AP1 RX No No   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:

AstraZeneca
Dow
Mallinckrodt
Express Scripts
Merck
Colorcon

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