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Progesterone - Generic Drug Details

What are the generic sources for progesterone and what is the scope of progesterone patent protection?

Progesterone is the generic ingredient in five branded drugs marketed by Amneal Pharms Ny, Bionpharma Inc, Dr Reddys Labs Inc, Sandoz Inc, Sofgen Pharms, Teva Pharms, Virtus Pharms, Allergan Sales Llc, Actavis Labs Ut Inc, Fresenius Kabi Usa, Hikma Farmaceutica, Lilly, Luitpold, Alza, and Ferring, and is included in fifteen NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are fifty-six drug master file entries for progesterone. Twenty-four suppliers are listed for this compound.

Summary for progesterone

US Patents:	3
Tradenames:	5
Applicants:	15
NDAs:	15
Drug Master File Entries:	56
Suppliers / Packagers:	24
Bulk Api Vendors:	86
Clinical Trials:	758
Patent Applications:	7,259
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for progesterone
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for progesterone
DailyMed Link:	progesterone at DailyMed

Pharmacology for progesterone

Ingredient-type	Progesterone
Drug Class	Progesterone

Medical Subject Heading (MeSH) Categories for progesterone

Progestins

Synonyms for progesterone

.beta.-Progesterone
.delta.-Pregnene-3,20-dione
.delta.(sup4)-Pregnene-3,20-dione
.delta.4-Pregnene-3,20-dione
(1S,10S,11S,14S,15S,2R)-14-acetyl-2,15-dimethyl-5-oxotetracyclo[8.7.0.0<2,7>.0 <11,15>]heptadec-6-ene
(1S,2R,10S,11S,14S,15S)-14-acetyl-2,15-dimethyltetracyclo[8.7.0.0;{2,7}.0;{11,15}]heptadec-6-en-5-one
(1S,2R,10S,11S,14S,15S)-14-ACETYL-2,15-DIMETHYLTETRACYCLO[8.7.0.0(2),?.0(1)(1),(1)?]HEPTADEC-6-EN-5-ONE
(8S,9S,10R,13S,14S,17S)-17-acetyl-10,13-dimethyl-1,2,6,7,8,9,10,11,12,13,14,15,16,17-tetradecahydro-3H-cyclopenta[a]phenanthren-3-one
(8S,9S,10R,13S,14S,17S)-17-Acetyl-10,13-dimethyl-1,2,6,7,8,9,11,12,14,15,16,17-dodecahydrocyclopenta[a]phenanthren-3-one
(8S,9S,10R,13S,14S,17S)-17-Acetyl-10,13-dimethyl-6,7,8,9,10,11,12,13,14,15,16,17-dodecahydro-1H-cyclopenta[a]phenanthren-3(2H)-one
(S)-4-Pregnene-3,20-dione
(S)-Pregn-4-en-3,20-dione
(S)-Progesterone
10324-EP2295503A1
10324-EP2301536A1
10324-EP2301538A1
10324-EP2311455A1
10324-EP2316452A1
17.alpha.-Hydroxy-6.alpha.-methylpregn-4-ene-3,20-dione
17.alpha.-Progesterone
17a-Progesterone
17alpha-Hydroxy-6alpha-methylpregn-4-ene-3,20-dione
17alpha-Progesterone
1a28
1dbb
1h60
257630-50-5
2aa6
3,20-Pregnene-4
32104FB6-BF81-4F6E-83C2-024DEEAEB272
4-Pregnen-3,20-dione
4-Pregnene-3,20-dione
4bb2
4G7DS2Q64Y
57-83-0
6.alpha.-Methylpregn-4-en-17.alpha.-ol-3,20-dione
6370-EP1441224A2
6370-EP2269989A1
6370-EP2269990A1
6370-EP2275420A1
6370-EP2284149A1
6370-EP2289892A1
6370-EP2292088A1
6370-EP2292233A2
6370-EP2292592A1
6370-EP2295055A2
6370-EP2295416A2
6370-EP2298731A1
6370-EP2298748A2
6370-EP2298764A1
6370-EP2298765A1
6370-EP2298772A1
6370-EP2305636A1
6370-EP2305642A2
6370-EP2308839A1
6370-EP2308880A1
6370-EP2311453A1
6alpha-Methylpregn-4-en-17alpha-ol-3,20-dione
753497-20-0
8012-32-6
8023-13-0
AB2000233
AC-700
AC1L1LKF
Agolutin
AI3-51682
AKOS015894908
Akrolutin
AN-15619
AS-12660
BB_NC-0185
BC200634
BDBM8903
beta-Progesterone
BHR-100
BHR-310
BIDD:ER0547
BIDD:PXR0094
Bio-luton
bmse000482
BPBio1_000676
BRD-K64994968-001-03-6
BSPBio_000614
BT000482
C00410
CAS-57-83-0
CCG-100766
CCRIS 533
CHEBI:17026
CHEMBL103
CIDR
CMC_13406
Colprosterone
component of Cyclogesterin
Corlutin
Corlutina
Corluvite
Corporin
Corpus luteum hormone
CPD000058345
Crinone
Crinone (TN)
Crinone progesterone gel
Crinone, Endometrin
CS-1937
CTK5A7509
Curretab
Cyclogest
Cyclogesterin
Cyclogesterin (Salt/Mix)
D00066
D07BSQ
D4-Pregnene-3,20-dione
DB00396
Delta(4)-pregnene-3,20-dione
delta(sup 4)-Pregnene-3,20-dione
delta(Sup4)-pregnene-3,20-dione
Delta4-Pregnen-3,20-dione
delta4-Pregnene-3,20-dione
DR-2011
DSSTox_CID_2370
DSSTox_GSID_22370
DSSTox_RID_76562
DTXSID3022370
Duraprogen
EBD2157912
EC 200-350-6
EINECS 200-350-6
Endometrin
Epitope ID:116051
Estima
ETI-411
EU-0100895
FE-999913
Flavolutan
Fologenon
Gelbkoerperhormon
Gelbkorperhormon
Gesterol
Gesterol 100
Gesterol 50
Gestiron
Gestone
Gestormone
Gestron
Glanducorpin
GTPL2377
Gynlutin
Gynoluton
Gynolutone
HMS1569O16
HMS2051O05
HMS2090J07
HMS2096O16
HMS2230F23
HMS2233P11
HMS3262D12
Hormoflaveine
Hormoluton
HSDB 3389
HY-N0437
Hydroxyprogesterone Caproic acid
J10165
KSC607K0T
Lingusorbs
Lipo-Lutin
Lipolutin
LMST02030159
Lopac0_000895
LP00895
LPCN-1107
LS-234
Lucorteum
Lucorteum Sol
Lugesteron
lugesterone
Luteal hormone
Luteinique
Luteocrin normale
Luteodyn
Luteogan
Luteohormone
Luteol
Luteol (VAN)
Luteopur
Luteosan
Luteostab
Luteovis
Luteum
Lutex
Lutidon
Lutin
Lutinus
Lutociclina
Lutocuclin M
Lutocyclin
Lutocyclin M
Lutocylin
Lutoform
Lutogyl
Lutogynon
Lutren
Lutromone
Membrettes
Methylpregnone
MFCD00003658
Micronized Progesterone
MLS000028517
MLS000758277
MLS001074187
MLS001423982
MLS002222367
MolPort-001-794-643
Nalutron
Natural Progesterone
NC00016
NCGC00015785-04
NCGC00022185-03
NCGC00022185-04
NCGC00022185-05
NCGC00022185-06
NCGC00022185-07
NCGC00022185-08
NCGC00022185-09
NCGC00022185-10
NCGC00022185-11
NCGC00022185-12
NCGC00090798-01
NCGC00090798-02
NCGC00254120-01
NCGC00259341-01
NCGC00261580-01
NCI60_042166
NSC 64377
NSC 9704
NSC-64377
NSC-9704
NSC64377
NSC9704
Opera_ID_292
P 0130
P0130_SIGMA
P0478
Percutacrine
Percutacrine Luteinique
Piaponon
PL000236
Pregn-4-en-3,20-dione
Pregn-4-ene-3, 17.alpha.-hydroxy-6.alpha.-methyl-
Pregn-4-ene-3,20-dione
Pregn-4-ene-3,20-dione, 17.alpha.-hydroxy-6.alpha.-methyl-
Pregn-4-ene-3,20-dione, 17alpha-hydroxy-6alpha-methyl-
Pregnene-3,20-dione
Pregnene, 3,20-dione-delta^4-
Pregnenedione
Prestwick_411
Prestwick0_000477
Prestwick1_000477
Prestwick2_000477
Prestwick3_000477
Primolut
Prochieve
PROG;
Progeffik
Progekan
Progestan
Progestasert
Progesterol
Progesteron
Progesterona
Progesterona [INN-Spanish]
Progesterone (JP17/USP/INN)
Progesterone (oral, preterm labor)
Progesterone (oral, preterm labor), Lipocine
Progesterone (Prometrium)
Progesterone [INN:BAN:JAN]
Progesterone [Progestins]
Progesterone [USP:INN:BAN:JAN]
Progesterone 1.0 mg/ml in Acetonitrile
Progesterone for peak identification, European Pharmacopoeia (EP) Reference Standard
Progesterone for system suitability, European Pharmacopoeia (EP) Reference Standard
Progesterone solution, 1.0 mg/mL in acetonitrile, ampule of 1 mL, certified reference material
Progesterone-Water Soluble, powder, BioReagent, suitable for cell culture
Progesterone, >=99%
Progesterone, British Pharmacopoeia (BP) Reference Standard
Progesterone, European Pharmacopoeia (EP) Reference Standard
Progesterone, gamma-irradiated, BioXtra, suitable for cell culture
Progesterone, meets USP testing specifications
Progesterone, pharmaceutical secondary standard; traceable to USP, PhEur and BP
Progesterone, powder, BioReagent, suitable for cell culture
Progesterone, United States Pharmacopeia (USP) Reference Standard
Progesterone, Vetec(TM) reagent grade, 98%
Progesterone, VETRANAL(TM), analytical standard
Progesterone; 4-Pregnene-3,20-dione
Progesterone??
Progesteronum
Progesteronum [INN-Latin]
Progestin
Progestogel
Progestol
Progeston
Progestone
Progestosol
Progestrel
Progestron
Progestronol
Projestaject
Prolets
Prolidon
Prolutin
Proluton
Prolutone
Prometrium
Prometrium (TN)
Prometrium;Agolutin;Corlutin
Prontogest
Protormone
Q-201624
RJKFOVLPORLFTN-LEKSSAKUSA-N
RL04181
S00293
s1705
SBB012538
SC-22719
SCHEMBL7671
SMR000058345
SMR000653542
SPBio_002553
Spectrum5_002053
SR-01000000088
SR-01000000088-5
SR-01000076054
SR-01000076054-4
ST069329
Syngesterone
Syngestrets
Synovex S
Syntolutan
Tox21_113157
Tox21_201792
Tox21_300307
Tox21_500895
TR-031737
U 3672
UNII-4G7DS2Q64Y
Utrogest
Utrogestan
Vitarrine
WLN: L E5 B666 OV MUTJ A1 E1 FV1
ZINC4428529

US Patents and Regulatory Information for progesterone

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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
Sofgen Pharms	PROGESTERONE	progesterone	CAPSULE;ORAL	200456-002	Sep 28, 2012	AB	RX	No	No	➤ Try a Free Trial	➤ Try a Free Trial				➤ Try a Free Trial
Sandoz Inc	PROGESTERONE	progesterone	CAPSULE;ORAL	205229-002	Oct 20, 2017	AB	RX	No	No	➤ Try a Free Trial	➤ Try a Free Trial				➤ Try a Free Trial
Actavis Labs Ut Inc	PROGESTERONE	progesterone	INJECTABLE;INJECTION	017362-002	Approved Prior to Jan 1, 1982	AO	RX	Yes	Yes	➤ Try a Free Trial	➤ Try a Free Trial				➤ Try a Free 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 progesterone

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Allergan Sales Llc	CRINONE	progesterone	GEL;VAGINAL	020701-001	Jul 31, 1997	➤ Try a Free Trial	➤ Try a Free Trial
Allergan Sales Llc	CRINONE	progesterone	GEL;VAGINAL	020701-002	Jul 31, 1997	➤ Try a Free Trial	➤ Try a Free Trial
Allergan Sales Llc	CRINONE	progesterone	GEL;VAGINAL	020701-002	Jul 31, 1997	➤ Try a Free Trial	➤ Try a Free Trial
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration

International Patents for progesterone

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Country	Document Number	Estimated Expiration
Israel	127129	➤ Try a Free Trial
European Patent Office	2386291	➤ Try a Free Trial
Japan	4667601	➤ Try a Free Trial
Country	Document Number	Estimated Expiration

Supplementary Protection Certificates for progesterone

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Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C0037	Belgium	➤ Try a Free Trial	PRODUCT NAME: OESTROGENES EQUINS CONJUGUES; ACETATE DE MEDROXYPROGESTERONE; NAT. REGISTRATION NO/DATE: NL 19569 19950301; FIRST REGISTRATION: CH - 52647 01 010 19940826
Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description