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Hydroxyprogesterone caproate - Generic Drug Details

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

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

Hydroxyprogesterone caproate has forty-nine patent family members in fourteen countries.

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

Summary for hydroxyprogesterone caproate

International Patents:	49
US Patents:	8
Tradenames:	5
Applicants:	9
NDAs:	13
Drug Master File Entries:	12
Suppliers / Packagers:	8
Bulk Api Vendors:	59
Clinical Trials:	26
Patent Applications:	5,286
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
DailyMed Link:	hydroxyprogesterone caproate at DailyMed

Pharmacology for hydroxyprogesterone caproate

Drug Class

Progestin

Synonyms for hydroxyprogesterone caproate

(1S,11S,15S,2R,10R,14R)-14-acetyl-2,15-dimethyl-5-oxotetracyclo[8.7.0.0<2,7>.0 <11,15>]heptadec-6-en-14-yl hexanoate

(1S,2R,10R,11S,14R,15S)-14-acetyl-2,15-dimethyl-5-oxotetracyclo[8.7.0.0^{2,7}.0^{11,15}]heptadec-6-en-14-yl hexanoate

(8R,9S,10R,13S,14S,17R)-17-acetyl-10,13-dimethyl-3-oxo-2,3,6,7,8,9,10,11,12,13,14,15,16,17-tetradecahydro-1H-cyclopenta[a]phenanthren-17-yl hexanoate

[(8R,9S,10R,13S,14S,17R)-17-acetyl-10,13-dimethyl-3-oxo-2,6,7,8,9,11,12,14,15,16-decahydro-1H-cyclopenta[a]phenanthren-17-yl] hexanoate

[(8R,9S,10R,13S,14S,17R)-17-ethanoyl-10,13-dimethyl-3-oxidanylidene-2,6,7,8,9,11,12,14,15,16-decahydro-1H-cyclopenta[a]phenanthren-17-yl] hexanoate

106111-89-1

17 -Hydroxyprogesterone Caproate

17-.alpha.-Hexanoyloxypregn-4-ene-3,20-dione

17-((1-Oxohexyl)oxy)pregn-4-ene-3,20-dione

17-alpha-Hexanoyloxypregn-4-ene-3,20-dione

17-alpha-Hydroxy progesterone n-caproate

17-alpha-hydroxy-progesterone caproate

17-alpha-Hydroxypregn-4-ene-3,20-dione hexanoate

17-alpha-Hydroxyprogesterone caproate

17-alpha-Hydroxyprogesterone hexanoate

17-Caproxyprogesterone

17-Caproyloxyprogesterone

17-Hydroxypregn-4-ene-3,20-dione caproate

17-Hydroxypregn-4-ene-3,20-dione hexanoate

17-OHPC

17.alpha.-Hydroxypregn-4-ene-3,20-dione caproate

17.alpha.-Hydroxypregn-4-ene-3,20-dione hexanoate

17.alpha.-Hydroxyprogesterone caproate

17.alpha.-Hydroxyprogesterone hexanoate

17.alpha.-Hydroxyprogesterone n-caproate

17|A-Hydroxyprogesterone caproate

17|A-Hydroxyprogesterone hexanoate

17a-hydroxyprogesterone caproate

17alpha-Caproyloxypregn-4-ene-3,20-dione

17alpha-Caproyloxyprogesterone

17alpha-hexanoyloxy-4pregnene-3,20-dione

17alpha-Hydroxypregn-4-ene-3,20-diene Caproate

17alpha-Hydroxyprogesteron-Caproat

17alpha-Hydroxyprogesterone caproate

17alpha-Hydroxyprogesterone caproate [Progestins]

17alpha-Hydroxyprogesterone hexanoate, >=98%

17alpha-Hydroxyprogesterone n-caproate

17alpha-Hydroxyprogesterone-17alpha caproate

2247-38-3

276F2O42F5

3,20-Dioxo-4-pregnen-17alpha-yl hexanoat

3,20-Dioxopregn-4-en-17-yl hexanoate

3,20-Dioxopregn-4-en-17.alpha.-yl caproate

3,20-Dioxopregn-4-en-17.alpha.-yl hexanoate #

3,20-Dioxopregn-4-en-17alpha-yl caproate

630-56-8

630H568

91037-33-1

A834188

AC1L54KP

AC1Q6OC8

ACN-037582

AKOS005267159

ARONIS24417

BCP16081

BDBM70293

C-22216

C08148

Caproate d'hydroxyprogesterone

Caproate d'hydroxyprogesterone [INN-French]

Caproato de hidroxiprogesterona

Caproato de hidroxiprogesterona [INN-Spanish]

Caproic acid hydroxyprogesterone

CAS-630-56-8

CC-29446

CHEBI:5812

CHEMBL1200848

cid_169870

Corlutin L.A.

CTK6D6716

D00949

DB06789

Delalutin

Delalutin (TN)

Deluteval 2X (Salt/Mix)

Depo-Proluton

DOMWKUIIPQCAJU-LJHIYBGHSA-N

DSSTox_CID_23915

DSSTox_GSID_43915

DSSTox_RID_80089

DTXSID6043915

Duraluton

EINECS 211-138-8

Estralutin

Gesterol LA 250

Gestiva

GS-3233

hexanoic acid [(8R,9S,10R,13S,14S,17R)-17-acetyl-10,13-dimethyl-3-oxo-2,6,7,8,9,11,12,14,15,16-decahydro-1H-cyclopenta[a]phenanthren-17-yl] ester

Hexanoic acid, ester with 17-hydroxypregn-4-ene-3,20-dione

HMS2230L08

Hormofort

HY-B0742

Hydroxyprogesterone caproate (JAN/USP/INN)

Hydroxyprogesterone caproate [USP:INN:JAN]

Hydroxyprogesterone caproate, United States Pharmacopeia (USP) Reference Standard

Hydroxyprogesterone hexanoate

Hydroxyprogesteroni caproas

Hydroxyprogesteroni caproas [INN-Latin]

Hylutin

Hylutin (TN)

Hyproval

Hyproval P.A.

Hyproval-PA

Hyroxon

Idrogestene

Idroprogesterone caproato

Idroprogesterone caproato [DCIT]

Kaprogest

Lewntogest

Lutate

Luteocrin

Luteocrin depot

Lutopron

Makena

Makena (TN)

MLS000028438

MLS001148643

MLS002207289

MolPort-002-529-231

NCGC00021268-03

NCGC00021268-04

NCGC00255784-01

Neolutin

Neolutin forte

NSC-17592

NSC17592

Opera_ID_1479

Oxiprogesterone Caproate

Pregn-4-ene-3, 17-[(1-oxohexyl)oxy]-

Pregn-4-ene-3, 17-hydroxy-, hexanoate

Pregn-4-ene-3,20-dione, 17-((1-oxohexyl)oxy)-

Pregn-4-ene-3,20-dione, 17-[(1-oxohexyl)oxy]-

Pregn-4-ene-3,20-dione, 17-hydroxy-, hexanoate

Primolut Depot

Proge

Progesterone caproate

Progesterone retard pharlon

Progesterone, 17-hydroxy-, hexanoate

Progesterone, hexanoate

Proluton Depot

Q-201222

Relutin

RL04400

s4674

SBB080822

SC-74381

SCHEMBL5330

SMR000058336

SR-01000003075

SR-01000003075-3

ST075196

Syngynon

Teralutil

TL8004370

Tox21_113502

Tox21_113502_1

Tox21_302333

UNII-276F2O42F5

ZINC4083606

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
Bristol Myers Squibb	DELALUTIN	hydroxyprogesterone caproate	SOLUTION;INTRAMUSCULAR	016911-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Amag Pharma Usa	MAKENA (AUTOINJECTOR)	hydroxyprogesterone caproate	SOLUTION;SUBCUTANEOUS	021945-004	Feb 14, 2018		RX	Yes	Yes			Y
Eugia Pharma	HYDROXYPROGESTERONE CAPROATE	hydroxyprogesterone caproate	SOLUTION;INTRAMUSCULAR	211142-001	May 9, 2019	AP2	RX	No	No
Aspen Global Inc	HYDROXYPROGESTERONE CAPROATE	hydroxyprogesterone caproate	SOLUTION;INTRAMUSCULAR	200271-001	Aug 24, 2015	AP2	RX	No	Yes
Eugia Pharma	HYDROXYPROGESTERONE CAPROATE	hydroxyprogesterone caproate	SOLUTION;INTRAMUSCULAR	211070-001	Apr 16, 2019	AP1	RX	No	No

International Patents for hydroxyprogesterone caproate

Country	Patent Number	Estimated Expiration
Spain	2716135
Japan	2008528126
European Patent Office	2953667
Australia	5470499
Denmark	1850892