Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

Get the Book: Make Better Decisions

Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

PDF eBook: Just $10 Get Print Book on Amazon

Serving leading biopharmaceutical companies globally:

Merck
Johnson and Johnson
Moodys
Medtronic
McKinsey
Boehringer Ingelheim

Last Updated: October 23, 2019

DrugPatentWatch Database Preview

MAKENA Drug Profile

See Plans and Pricing

« Back to Dashboard

Which patents cover Makena, and what generic alternatives are available?

Makena is a drug marketed by Amag Pharma Usa and is included in one NDA. There are eight patents protecting this drug.

The generic ingredient in MAKENA is hydroxyprogesterone caproate. There are twelve drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the hydroxyprogesterone caproate profile page.

Drug patent expirations by year for MAKENA
Drug Prices for MAKENA

See drug prices for MAKENA

Recent Clinical Trials for MAKENA

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

SponsorPhase
AMAG Pharmaceuticals, Inc.Phase 1
George Washington UniversityPhase 4
Thomas Jefferson UniversityPhase 4

See all MAKENA clinical trials

Pharmacology for MAKENA
Drug ClassProgestin
Synonyms for MAKENA
(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
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 (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 MAKENA

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 hydroxyprogesterone caproate SOLUTION;INTRAMUSCULAR 021945-001 Feb 3, 2011 AP1 RX Yes Yes   Start Trial   Start Trial   Start Trial
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 Y   Start Trial
Amag Pharma Usa MAKENA (AUTOINJECTOR) hydroxyprogesterone caproate SOLUTION;SUBCUTANEOUS 021945-004 Feb 14, 2018 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Merck
Johnson and Johnson
Colorcon
McKinsey
Harvard Business School
Boehringer Ingelheim

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 verifification 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.