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Progesterone - Generic Drug Details

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What are the generic drug 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.

Progesterone has twelve patent family members in nine countries.

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

Summary for progesterone

International Patents:	12
US Patents:	3
Tradenames:	5
Applicants:	15
NDAs:	15
Drug Master File Entries:	55
Suppliers / Packagers:	24
Bulk Api Vendors:	91
Clinical Trials:	758
Patent Applications:	7,267
Formulation / Manufacturing:	see details
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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Luitpold	PROGESTERONE	progesterone	INJECTABLE;INJECTION	090845-001	Jun 22, 2009	AO	RX	No	No
Sandoz Inc	PROGESTERONE	progesterone	CAPSULE;ORAL	205229-001	Oct 20, 2017	AB	RX	No	No
Bionpharma Inc	PROGESTERONE	progesterone	CAPSULE;ORAL	200900-001	Aug 16, 2013	AB	RX	No	No
Amneal Pharms Ny	PROGESTERONE	progesterone	CAPSULE;ORAL	207724-001	Sep 7, 2017	AB	RX	No	No

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Expired US Patents for progesterone

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

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International Patents for progesterone

Country	Document Number	Estimated Expiration
Australia	1176200
World Intellectual Property Organization (WIPO)	0028970
Japan	4667601
European Patent Office	1131052

Supplementary Protection Certificates for progesterone

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