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Generated: July 17, 2018

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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 Bristol Myers Squibb, Akorn, Allergan Sales Llc, Aspen Global Inc, Luitpold Pharms Inc, and Amag Pharma Usa, and is included in seven NDAs. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Hydroxyprogesterone caproate has forty-one patent family members in twelve countries.

There are twelve drug master file entries for hydroxyprogesterone caproate. Five suppliers are listed for this compound.
Pharmacology for hydroxyprogesterone caproate
Ingredient-typeProgesterone Congeners
Drug ClassProgestin
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-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
17a-Hydroxyprogesteronecaproate
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
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
BDBM70293
Bio-0667
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
D00AEQ
DB06789
Delalutin
Delalutin (TN)
Deluteval 2X (Salt/Mix)
Depo-Proluton
DOMWKUIIPQCAJU-LJHIYBGHSA-N
DR002646
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
LP100597
Lutate
Luteocrin
Luteocrin depot
Lutopron
Makena
Makena (TN)
MFCD00072134
MLS000028438
MLS001148643
MLS002207289
MolPort-002-529-231
NCGC00021268-03
NCGC00021268-04
NCGC00255784-01
Neolutin
Neolutin forte
NSC-17592
NSC17592
Opera_ID_1479
Oxiprogesterone Caproate
oxyprogesterone 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
Proluton depot (TN)
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 INJECTABLE;INJECTION 016911-001 Approved Prior to Jan 1, 1982 DISCN Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Amag Pharma Usa MAKENA PRESERVATIVE FREE hydroxyprogesterone caproate SOLUTION;INTRAMUSCULAR 021945-002 Feb 19, 2016 AP RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Amag Pharma Usa MAKENA (AUTOINJECTOR) hydroxyprogesterone caproate SOLUTION;SUBCUTANEOUS 021945-004 Feb 14, 2018 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Allergan Sales Llc HYDROXYPROGESTERONE CAPROATE hydroxyprogesterone caproate INJECTABLE;INJECTION 017439-002 Approved Prior to Jan 1, 1982 DISCN No 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

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Non-Orange Book US Patents for hydroxyprogesterone caproate

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,428,528 Needle assisted jet injector ➤ Sign Up
6,565,553 Needle assisted jet injector ➤ Sign Up
6,746,429 Needle assisted jet injector ➤ Sign Up
7,744,582 Needle assisted jet injector ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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