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.

Summary for hydroxyprogesterone caproate

International Patents:	43
US Patents:	10
Tradenames:	5
Applicants:	10
NDAs:	15
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	7
Raw Ingredient (Bulk) Api Vendors:	69
Clinical Trials:	30
Patent Applications:	7,325
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for hydroxyprogesterone caproate
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for hydroxyprogesterone caproate
What excipients (inactive ingredients) are in hydroxyprogesterone caproate?	hydroxyprogesterone caproate excipients list
DailyMed Link:	hydroxyprogesterone caproate at DailyMed

See drug prices for hydroxyprogesterone caproate

Recent Clinical Trials for hydroxyprogesterone caproate

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

Sponsor	Phase
Bezmialem Vakif University	N/A
Assiut University	Phase 4
Aswan University Hospital	N/A

See all hydroxyprogesterone caproate clinical trials

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

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Glossary

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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

Expired US Patents for hydroxyprogesterone caproate

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Covis	MAKENA (AUTOINJECTOR)	hydroxyprogesterone caproate	SOLUTION;SUBCUTANEOUS	021945-004	Feb 14, 2018	See Plans and Pricing	See Plans and Pricing
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for hydroxyprogesterone caproate

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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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.