Hydroxyprogesterone caproate - Generic Drug Details

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What are the generic drug 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. One supplier is listed for this compound.

Sponsor

Phase

Bezmialem Vakif University

N/A

Assiut University

Phase 4

Aswan University Hospital

N/A

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

Tradename

Dosage

Ingredient

Strength

NDA

ANDAs Submitted

Submissiondate

Injection (Auto- injector)

275 mg/1.1 mL

2020-09-28

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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
Bristol Myers Squibb	DELALUTIN	hydroxyprogesterone caproate	SOLUTION;INTRAMUSCULAR	010347-004	Approved Prior to Jan 1, 1982		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Allergan	HYDROXYPROGESTERONE CAPROATE	hydroxyprogesterone caproate	INJECTABLE;INJECTION	017439-002	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Bristol Myers Squibb	DELALUTIN	hydroxyprogesterone caproate	SOLUTION;INTRAMUSCULAR	010347-002	Approved Prior to Jan 1, 1982		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

US Patents:	0
Tradenames:	2
Applicants:	5
NDAs:	6
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	73
Clinical Trials:	30
Patent Applications:	7,082
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