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Last Updated: March 29, 2024

Hydroxyprogesterone caproate - Generic Drug Details


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What are the generic sources for hydroxyprogesterone caproate and what is the scope of freedom to operate?

Hydroxyprogesterone caproate is the generic ingredient in two branded drugs marketed by Allergan, Epic Pharma Llc, Bristol Myers Squibb, Aspen Global Inc, and Eugia Pharma, and is included in six NDAs. Additional information is available in the individual branded drug profile pages.

There are ten drug master file entries for hydroxyprogesterone caproate. Two 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
Bezmialem Vakif UniversityN/A
Assiut UniversityPhase 4
Aswan University HospitalN/A

See all hydroxyprogesterone caproate clinical trials

Pharmacology for hydroxyprogesterone caproate
Drug ClassProgestin
Paragraph IV (Patent) Challenges for HYDROXYPROGESTERONE CAPROATE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
MAKENA (AUTOINJECTOR) Injection (Auto- injector) hydroxyprogesterone caproate 275 mg/1.1 mL 021945 1 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
Eugia Pharma HYDROXYPROGESTERONE CAPROATE hydroxyprogesterone caproate SOLUTION;INTRAMUSCULAR 211142-001 May 9, 2019 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Allergan HYDROXYPROGESTERONE CAPROATE hydroxyprogesterone caproate INJECTABLE;INJECTION 017439-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Aspen Global Inc HYDROXYPROGESTERONE CAPROATE hydroxyprogesterone caproate SOLUTION;INTRAMUSCULAR 200271-001 Aug 24, 2015 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Bristol Myers Squibb DELALUTIN hydroxyprogesterone caproate SOLUTION;INTRAMUSCULAR 010347-002 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Bristol Myers Squibb DELALUTIN hydroxyprogesterone caproate SOLUTION;INTRAMUSCULAR 010347-004 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Allergan HYDROXYPROGESTERONE CAPROATE hydroxyprogesterone caproate INJECTABLE;INJECTION 017439-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Bristol Myers Squibb DELALUTIN hydroxyprogesterone caproate SOLUTION;INTRAMUSCULAR 016911-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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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