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Last Updated: November 27, 2022

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 Covis, and is included in fifteen NDAs. There are ten patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

There are ten 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

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SponsorPhase
Bezmialem Vakif UniversityN/A
Assiut UniversityPhase 4
Aswan University HospitalN/A

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Pharmacology for hydroxyprogesterone caproate
Drug Class Progestin
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
Covis MAKENA (AUTOINJECTOR) hydroxyprogesterone caproate SOLUTION;SUBCUTANEOUS 021945-004 Feb 14, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Bristol Myers Squibb DELALUTIN hydroxyprogesterone caproate SOLUTION;INTRAMUSCULAR 016911-002 Approved Prior to Jan 1, 1982 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Am Regent HYDROXYPROGESTERONE CAPROATE hydroxyprogesterone caproate SOLUTION;INTRAMUSCULAR 210724-001 Aug 9, 2019 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for hydroxyprogesterone caproate

Country Patent Number Title Estimated Expiration
Japan 6457383 See Plans and Pricing
Canada 2900672 DISPOSITIF D'INJECTION A JET ASSISTEE PAR AIGUILLE AYANT UNE FORCE DE DECLENCHEMENT REDUITE (NEEDLE ASSISTED JET INJECTION DEVICE HAVING REDUCED TRIGGER FORCE) See Plans and Pricing
European Patent Office 1850892 INJECTEUR A SERINGUE PREREMPLIE ASSISTE D'UNE AIGUILLE (PREFILLED NEEDLE ASSISTED SYRINGE JET INJECTOR) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

AstraZeneca
Dow
Mallinckrodt
Express Scripts
Merck
Colorcon

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