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 six branded drugs marketed by Akorn, Allergan, Bristol Myers Squibb, Am Regent, Aspen, Aspen Global Inc, Eugia Pharma, Slayback Pharma Llc, Sun Pharm, and Amag Pharma Usa, and is included in fifteen NDAs. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Hydroxyprogesterone caproate has fifty patent family members in fifteen countries.

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

Summary for hydroxyprogesterone caproate

International Patents:	50
US Patents:	9
Tradenames:	6
Applicants:	10
NDAs:	15
Drug Master File Entries:	12
Suppliers / Packagers:	9
Bulk Api Vendors:	60
Clinical Trials:	27
Patent Applications:	5,546
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

See drug prices for hydroxyprogesterone caproate

Recent Clinical Trials for hydroxyprogesterone caproate

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

Sponsor	Phase
Assiut University	Phase 4
Aswan University Hospital	N/A
University of North Carolina, Chapel Hill	Phase 3

See all hydroxyprogesterone caproate clinical trials

Recent Litigation for hydroxyprogesterone caproate

Identify potential future generic entrants

District Court Litigation

Case Name	Date
Antares Pharma Inc. v. Medac Pharma Inc.	2014-07-21

See all hydroxyprogesterone caproate litigation

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

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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
Amag Pharma Usa	MAKENA (AUTOINJECTOR)	hydroxyprogesterone caproate	SOLUTION;SUBCUTANEOUS	021945-004	Feb 14, 2018		RX	Yes	Yes	Start Trial	Start Trial	Y			Start Trial
Amag Pharma Usa	MAKENA (AUTOINJECTOR)	hydroxyprogesterone caproate	SOLUTION;SUBCUTANEOUS	021945-004	Feb 14, 2018		RX	Yes	Yes	Start Trial	Start Trial				Start Trial
Aspen Global Inc	HYDROXYPROGESTERONE CAPROATE	hydroxyprogesterone caproate	SOLUTION;INTRAMUSCULAR	200271-001	Aug 24, 2015		RX	No	Yes	Start Trial	Start Trial				Start Trial
Sun Pharm	HYDROXYPROGESTERONE CAPROATE	hydroxyprogesterone caproate	SOLUTION;INTRAMUSCULAR	208381-001	Apr 9, 2019	AP1	RX	No	No	Start Trial	Start Trial				Start Trial
>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
Amag Pharma Usa	MAKENA (AUTOINJECTOR)	hydroxyprogesterone caproate	SOLUTION;SUBCUTANEOUS	021945-004	Feb 14, 2018	Start Trial	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for hydroxyprogesterone caproate

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Country	Patent Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	2013169800	Start Trial
Japan	2015516845	Start Trial
Hungary	E042286	Start Trial
Portugal	1850892	Start Trial
>Country	>Patent Number	>Estimated Expiration

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