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PROMACTA Drug Patent Profile

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

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

This drug has one hundred and eight patent family members in forty countries.

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

DrugPatentWatch^® Generic Entry Outlook for Promacta

Promacta was eligible for patent challenges on November 20, 2012.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 1, 2028. This may change due to patent challenges or generic licensing.

There are two Paragraph IV patent challenges for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

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Summary for PROMACTA

International Patents:	108
US Patents:	6
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	72
Clinical Trials:	31
Patent Applications:	319
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for PROMACTA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PROMACTA
What excipients (inactive ingredients) are in PROMACTA?	PROMACTA excipients list
DailyMed Link:	PROMACTA at DailyMed

Drug patent expirations by year for PROMACTA

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for PROMACTA

Generic Entry Date for PROMACTA^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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.

Recent Clinical Trials for PROMACTA

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

Sponsor	Phase
University of California, San Francisco	Phase 1
Food and Drug Administration (FDA)	Phase 1
Anjali Pawar	Phase 1

See all PROMACTA clinical trials

Pharmacology for PROMACTA

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

Anatomical Therapeutic Chemical (ATC) Classes for PROMACTA

B02BX	Other systemic hemostatics
B02B	VITAMIN K AND OTHER HEMOSTATICS
B02	ANTIHEMORRHAGICS
B	Blood and blood forming organs

Paragraph IV (Patent) Challenges for PROMACTA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
PROMACTA	Tablets	eltrombopag olamine	12.5 mg and 25 mg	022291	1	2014-02-04
PROMACTA	Tablets	eltrombopag olamine	50 mg and 75 mg	022291	1	2014-01-07

US Patents and Regulatory Information for PROMACTA

PROMACTA is protected by six US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of PROMACTA is ⤷ Sign Up.

This potential generic entry date is based on patent ⤷ Sign Up.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting PROMACTA

3'-[(2z)-[1-(3,4-Dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4h-pyrazol-4-y- lidene]hy-drazino]-2'-hydroxy-[1,1'-piphenyl]-acid bis-(monoethanolamine)
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

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)
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

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)
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

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 bis-(monoethanolamine)
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

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)
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

FDA Regulatory Exclusivity protecting PROMACTA

INDICATED IN COMBINATION WITH STANDARD IMMUNOSUPPRESSIVE THERAPY FOR THE FIRST-LINE TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS AND OLDER WITH SEVERE APLASTIC ANEMIA
Exclusivity Expiration: ⤷ Sign Up

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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
Novartis	PROMACTA KIT	eltrombopag olamine	FOR SUSPENSION;ORAL	207027-002	Sep 27, 2018		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Novartis	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-003	Sep 8, 2009		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Novartis	PROMACTA KIT	eltrombopag olamine	FOR SUSPENSION;ORAL	207027-001	Aug 24, 2015		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Novartis	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-005	Nov 16, 2012		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Novartis	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-004	Oct 20, 2011		RX	Yes	No	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Novartis	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-002	Nov 20, 2008		RX	Yes	No	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Novartis	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-003	Sep 8, 2009		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
>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 PROMACTA

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-005	Nov 16, 2012	⤷ Sign Up	⤷ Sign Up
Novartis	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-002	Nov 20, 2008	⤷ Sign Up	⤷ Sign Up
Novartis	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-003	Sep 8, 2009	⤷ Sign Up	⤷ Sign Up
Novartis	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-001	Nov 20, 2008	⤷ Sign Up	⤷ Sign Up
Novartis	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-003	Sep 8, 2009	⤷ Sign Up	⤷ Sign Up
Novartis	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-002	Nov 20, 2008	⤷ Sign Up	⤷ Sign Up
Novartis	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-001	Nov 20, 2008	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for PROMACTA

When does loss-of-exclusivity occur for PROMACTA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 9656
Estimated Expiration: ⤷ Sign Up

Patent: 7711
Estimated Expiration: ⤷ Sign Up

Australia

Patent: 07352608
Estimated Expiration: ⤷ Sign Up

Brazil

Patent: 0721651
Estimated Expiration: ⤷ Sign Up

Canada

Patent: 85831
Estimated Expiration: ⤷ Sign Up

Chile

Patent: 07002242
Estimated Expiration: ⤷ Sign Up

China

Patent: 1686930
Estimated Expiration: ⤷ Sign Up

Patent: 2688207
Estimated Expiration: ⤷ Sign Up

Patent: 2697745
Estimated Expiration: ⤷ Sign Up

Colombia

Patent: 60058
Estimated Expiration: ⤷ Sign Up

Costa Rica

Patent: 143
Estimated Expiration: ⤷ Sign Up

Croatia

Patent: 0160206
Estimated Expiration: ⤷ Sign Up

Cyprus

Patent: 17284
Estimated Expiration: ⤷ Sign Up

Denmark

Patent: 52237
Estimated Expiration: ⤷ Sign Up

Dominican Republic

Patent: 009000253
Estimated Expiration: ⤷ Sign Up

Ecuador

Patent: 077628
Estimated Expiration: ⤷ Sign Up

Eurasian Patent Organization

Patent: 0883
Estimated Expiration: ⤷ Sign Up

Patent: 4294
Estimated Expiration: ⤷ Sign Up

Patent: 0971018
Estimated Expiration: ⤷ Sign Up

Patent: 1400387
Estimated Expiration: ⤷ Sign Up

Patent: 1991590
Estimated Expiration: ⤷ Sign Up

European Patent Office

Patent: 52237
Estimated Expiration: ⤷ Sign Up

Patent: 90730
Estimated Expiration: ⤷ Sign Up

Patent: 18732
Estimated Expiration: ⤷ Sign Up

Patent: 18733
Estimated Expiration: ⤷ Sign Up

Hong Kong

Patent: 36968
Estimated Expiration: ⤷ Sign Up

Hungary

Patent: 27209
Estimated Expiration: ⤷ Sign Up

Israel

Patent: 1891
Estimated Expiration: ⤷ Sign Up

Patent: 8840
Estimated Expiration: ⤷ Sign Up

Patent: 4602
Estimated Expiration: ⤷ Sign Up

Japan

Patent: 19866
Estimated Expiration: ⤷ Sign Up

Patent: 35078
Estimated Expiration: ⤷ Sign Up

Patent: 44713
Estimated Expiration: ⤷ Sign Up

Patent: 60289
Estimated Expiration: ⤷ Sign Up

Patent: 10526140
Estimated Expiration: ⤷ Sign Up

Patent: 14005302
Estimated Expiration: ⤷ Sign Up

Patent: 15129195
Estimated Expiration: ⤷ Sign Up

Patent: 17137343
Estimated Expiration: ⤷ Sign Up

Patent: 19123747
Estimated Expiration: ⤷ Sign Up

Patent: 21100968
Estimated Expiration: ⤷ Sign Up

Patent: 23011888
Estimated Expiration: ⤷ Sign Up

Jordan

Patent: 43
Estimated Expiration: ⤷ Sign Up

Malaysia

Patent: 8072
Estimated Expiration: ⤷ Sign Up

Mexico

Patent: 09011881
Estimated Expiration: ⤷ Sign Up

Morocco

Patent: 236
Estimated Expiration: ⤷ Sign Up

New Zealand

Patent: 0888
Estimated Expiration: ⤷ Sign Up

Peru

Patent: 080773
Estimated Expiration: ⤷ Sign Up

Patent: 121407
Estimated Expiration: ⤷ Sign Up

Patent: 151953
Estimated Expiration: ⤷ Sign Up

Poland

Patent: 52237
Estimated Expiration: ⤷ Sign Up

Portugal

Patent: 52237
Estimated Expiration: ⤷ Sign Up

Slovenia

Patent: 52237
Estimated Expiration: ⤷ Sign Up

South Africa

Patent: 0907710
Estimated Expiration: ⤷ Sign Up

South Korea

Patent: 1475971
Estimated Expiration: ⤷ Sign Up

Patent: 1537200
Estimated Expiration: ⤷ Sign Up

Patent: 1632851
Estimated Expiration: ⤷ Sign Up

Patent: 100020456
Estimated Expiration: ⤷ Sign Up

Patent: 140049086
Estimated Expiration: ⤷ Sign Up

Patent: 150008513
Estimated Expiration: ⤷ Sign Up

Spain

Patent: 65179
Estimated Expiration: ⤷ Sign Up

Taiwan

Patent: 39267
Estimated Expiration: ⤷ Sign Up

Patent: 38674
Estimated Expiration: ⤷ Sign Up

Patent: 0843742
Estimated Expiration: ⤷ Sign Up

Patent: 1410240
Estimated Expiration: ⤷ Sign Up

Ukraine

Patent: 261
Estimated Expiration: ⤷ Sign Up

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering PROMACTA around the world.

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Country	Patent Number	Title	Estimated Expiration
Iceland	2770		⤷ Sign Up
Japan	2005526143		⤷ Sign Up
Hong Kong	1136968	新穎的藥物組合物 (NOVEL PHARMACEUTICAL COMPOSITION)	⤷ Sign Up
Israel	164966		⤷ Sign Up
Japan	3813875		⤷ Sign Up
Taiwan	201410240	Pharmaceutical tablets, solid oral pharmaceutical dosage forms, pharmaceutical capsules and pharmaceutical granules comprising 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-ylidene]hydrazino]-2'-hydroxy-[1,1'-biphenyl]-3-carbox	⤷ Sign Up
Argentina	107711	COMPRIMIDO FARMACÉUTICO, GRÁNULOS FARMACÉUTICOS Y PROCEDIMIENTO PARA SU PREPARACIÓN, FORMA FARMACÉUTICA ORAL SÓLIDA, CÁPSULA	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for PROMACTA

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1534390	91 3-2010	Slovakia	⤷ Sign Up	PRODUCT NAME: ELTROMBOPAG; REGISTRATION NO/DATE: EU/1/10/612/001 - EU/1/10/612/006 20100315
1534390	C20100006 00032	Estonia	⤷ Sign Up	PRODUCT NAME: REVOLADE-ELTROMBOPAG; REG NO/DATE: C(2010)1662 11.03.2010
1294378	10C0034	France	⤷ Sign Up	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 20100315
1294378	122010000037	Germany	⤷ Sign Up	PRODUCT NAME: ELTROMBOPAG SOWIE PHARMAZEUTISCH ANNEHMBARE SALZE, HYDRATE UND SOLVATE DAVON; NAT. REGISTRATION NO/DATE: EU/1/10/612/001-006 20100311; FIRST REGISTRATION: EU EU/1/10/612/001-/006 20100311
1294378	C201000022	Spain	⤷ Sign Up	PRODUCT NAME: ELTROMBOPAG; NATIONAL AUTHORISATION NUMBER: EU/1/10/612/001-006; DATE OF AUTHORISATION: 20100315; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/10/612/001-006; DATE OF FIRST AUTHORISATION IN EEA: 20100315
1294378	2010C/018	Belgium	⤷ Sign Up	PRODUCT NAME: ELTROMBOPAG, OPTIONNELLEMENT SOUS FORME DE SEL OU SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE (Y COMPRIS UN HYDRATE); AUTHORISATION NUMBER AND DATE: EU/1/10/612/001 20100315
1534390	PA2010007	Lithuania	⤷ Sign Up	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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

Indicators of Generic Entry

Summary for PROMACTA

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for PROMACTA

Recent Clinical Trials for PROMACTA

Pharmacology for PROMACTA

Anatomical Therapeutic Chemical (ATC) Classes for PROMACTA

Paragraph IV (Patent) Challenges for PROMACTA

Patents protecting PROMACTA

FDA Regulatory Exclusivity protecting PROMACTA

When does loss-of-exclusivity occur for PROMACTA?

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

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for PROMACTA