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PROMACTA Drug Profile

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When do Promacta patents expire, and what generic alternatives are available?

Promacta is a drug marketed by Novartis Pharms Corp and is included in two NDAs. There are fourteen patents protecting this drug and two Paragraph IV challenges.

This drug has one hundred and eighty-seven patent family members in forty countries.

The generic ingredient in PROMACTA is eltrombopag olamine. There are three drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the eltrombopag olamine profile page.

Summary for PROMACTA

International Patents:	187
US Patents:	14
Applicants:	1
NDAs:	2
Suppliers / Packagers:	2
Bulk Api Vendors:	71
Clinical Trials:	25
Patent Applications:	37
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for PROMACTA
DailyMed Link:	PROMACTA at DailyMed

Generic Entry Opportunity Date for PROMACTA

NDA:

207027

Dosage:

FOR SUSPENSION;ORAL

NDA:

022291

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for PROMACTA

Drug Class	Thrombopoietin Receptor Agonist
Mechanism of Action	Thrombopoietin Receptor Agonists Organic Anion Transporting Polypeptide 1B1 Inhibitors Breast Cancer Resistance Protein Inhibitors UGT1A1 Inhibitors UGT1A3 Inhibitors UGT1A4 Inhibitors UGT1A6 Inhibitors UGT1A9 Inhibitors UGT2B7 Inhibitors UGT2B15 Inhibitors
Physiological Effect	Increased Megakaryocyte Maturation Increased Platelet Production

Synonyms for PROMACTA

(1,1'-Biphenyl)-3-carboxylic acid, 3'-((2Z)-(1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-ylidene)hydrazino)-2'-hydroxy-

(1,1'-Biphenyl)-3-carboxylic acid, 3'-((2Z)-(1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-ylidene)hydrazino)-2'-hydroxy, compound with 2-Aminoethanol (1:2)

(E)-3'-(2-(2-(3,4-dimethylphenyl)-5-methyl-3-oxo-2,3-dihydro-1H-pyrazol-4-yl)hydrazono)-2'-oxo-2',3'-dihydro-[1,1'-biphenyl]-3-carboxylic acid

(E)-3\'-(2-(1-(3,4-Dimethylphenyl)-3-methyl-5-oxo-1H-pyrazol-4(5H)-ylidene)hydrazinyl)-2\'-hydroxybiphenyl-3-carboxylic acid

(Z)-3'-(2-(1-(3,4-Dimethylphenyl)-3-methyl-5-oxo-1H-pyrazol-4(5H)-ylidene)hydrazinyl)-2'-hydroxy-[1,

(Z)-3'-(2-(1-(3,4-Dimethylphenyl)-3-methyl-5-oxo-1H-pyrazol-4(5H)-ylidene)hydrazinyl)-2'-hydroxy-[1,1'-biphenyl]-3-carboxylic acid

[1,1'-Biphenyl]-3-carboxylic acid, 3'-[(2Z)-[1-(3,4-dime

1807882-48-9

2-aminoethan-1-ol hemi((E)-3'-(2-(2-(3,4-dimethylphenyl)-5-methyl-3-oxo-2,3-dihydro-1H-pyrazol-4-yl)hydrazono)-2'-oxo-2',3'-dihydro-[1,1'-biphenyl]-3-carboxylate)

2-aminoethanol with (Z)-3'-(2-(1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1H-pyrazol-4(5H)-ylidene)hydrazinyl)-2'-hydroxy-[1,1'-biphenyl]-3-carboxylate (2:1)

3-[(5E)-5-[[2-(3,4-dimethylphenyl)-5-methyl-3-oxo-1H-pyrazol-4-yl]hydrazono]-6-oxo-cyclohexa-1,3-dien-1-yl]benzoic acid

3'-((2Z)-2-(1-(3,4-Dimethylphenyl)-3-methyl-5-oxo-1,5-dihydro-4H-pyrazol-4-ylidene)diazanyl)-2'-hydroxybiphenyl-3-carboxylic acid compound with 2-aminoethanol (1:2)

3'-[2-[(2Z)-1-(3,4-Dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-ylidene]hydrazinyl]-2'-hydroxy-[1,1'-biphenyl]-3-carboxylic acid

3'-{(2z)-2-(1-[3,4-dimethylphenyl]-3-methyl-5-oxo-1,5-dihydro-4h-pyrazol-4-ylidene)diazanyl}-2'-hydroxybiphenyl-3-carboxylic acid

3'-{(2Z)-2-[1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1,5-dihydro-4H-pyrazol-4-ylidene]hydrazino}-2'-hydroxybiphenyl-3-carboxylic acid

3'-{(2Z)-2-[1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1,5-dihydro-4H-pyrazol-4-ylidene]hydrazinyl}-2'-hydroxy[1,1'-biphenyl]-3-carboxylic acid

3'-{N'-[1-(3,4-dimethyl-phenyl)-3-methyl-5-oxo-1,5-dihydropyrazol-4-ylidene]hydrazino}-2'-hydroxybiphenyl-3-carboxylic acid

3608AH

443130-00-5

496775-61-2

496775-62-3

4CA-0492

4U07F515LG

775E612

A25156

AB01274808_02

AB01274808-01

AB1008446

ABP000381

AC-26286

AK-72820

AK174001

AKOS015920246

AKOS025396658

AKOS030524935

AN-589

BC678699

BCP9000641

BCPP000243

BR-72820

C25H22N4O4.2C2H7NO

CHEBI:85010

CHEMBL3186485

CHEMBL461806

CS-1565

CS-1566

D00PEH

D03978

DB06210

Eltrombopag

Eltrombopag (Olamine)

Eltrombopag [INN]

EltroMbopag diethanolaMine salt

Eltrombopag olamine

Eltrombopag olamine (JAN/USAN)

Eltrombopag olamine [USAN:JAN]

Eltrombopag/

EN002876

EX-7216

EX-A443

HSDB 8212

HY-15306

HY-15306A

MFCD21090400

MFCD22380664

MolPort-006-170-138

MolPort-006-393-918

MolPort-009-679-439

MolPort-028-745-010

MolPort-042-652-614

ppromacta

Promacta (TN)

PubChem20546

Revolade

s4502

S56D65XJ9G

SB 497115

SB 497115GR

SB-497115

SB-497115-GR

SB497115

SC-27871

SCHEMBL16207741

SCHEMBL164270

SCHEMBL210183

SCHEMBL211081

SCHEMBL211082

SCHEMBL2236368

SCHEMBL2236372

ST2402915

Thylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-ylidene]hydrazino]-2'-hydroxy-(9CI)

UNII-4U07F515LG

UNII-S56D65XJ9G

X5021

ZINC100794657

US Patents and Regulatory Information for PROMACTA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis Pharms Corp	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-003	Sep 8, 2009		RX	Yes	Yes					Y
Novartis Pharms Corp	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-005	Nov 16, 2012		RX	Yes	Yes
Novartis Pharms Corp	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-001	Nov 20, 2008		RX	Yes	No					Y
Novartis Pharms Corp	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-003	Sep 8, 2009		RX	Yes	Yes
Novartis Pharms Corp	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-002	Nov 20, 2008		RX	Yes	No					Y
Novartis Pharms Corp	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-001	Nov 20, 2008		RX	Yes	No					Y

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Paragraph IV (Patent) Challenges for PROMACTA

Drugname	Dosage	Strength	RLD	Date
	Tablets	50 mg and 75 mg
	Tablets	12.5 mg and 25 mg

Non-Orange Book US Patents for PROMACTA

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
7,674,887	Thrombopoietin mimetics
8,088,813	3'-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-y- lidene]hydrazino]-2'-hydroxy-[1,1'-biphenyl]-3-carboxylic acid bis-(monoethanolamine)
6,211,200	Metal complexes
8,846,024	3'-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-y- lidene]hydrazino]-2'-hydroxy-[1,1'-biphenyl]-3-carboxylic acid bis-(monoethanolamine)
7,335,649	Thrombopoietin mimetics
6,413,952	Agonizing dimeric cell-surface receptors with a receptor binding moiety and chelating metal

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International Patents for PROMACTA

Country	Document Number	Estimated Expiration
Slovenia	1864981
Germany	60140224
Japan	2010265317
Peru	19532015
Portugal	1889838
Japan	2017137343

Supplementary Protection Certificates for PROMACTA

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C0034	France		PRODUCT NAME: ELTROMBOPAG EVENTUELLEMENT SOUS LA FORME D'UN SEL OU D'UN SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE (INCLUANT UN HYDRATE; REGISTRATION NO/DATE: EU/1/10/612/001 20100311
2010 00017	Denmark
2010007	Lithuania		PRODUCT NAME: ELTROMBOPAGUM OLAMINUM; REGISTRATION NO/DATE: EU/1/10/612/001, 2010 03 11 EU/1/10/612/002, 2010 03 11 EU/1/10/612/003, 2010 03 11 EU/1/10/612/004, 2010 03 11 EU/1/10/612/005, 2010 03 11 EU/1/10/612/006 20100311
681	Luxembourg		91681, EXPIRES: 20250311
1294378/01	Switzerland		FORMER OWNER: GLAXOSMITHKLINE LLC, US
/2010	Austria		PRODUCT NAME: ELTROMBOPAG, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, HYDRATS UND SOLVATS DAVON; REGISTRATION NO/DATE: EU/1/10/612/001-006 20100311