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Last Updated: November 21, 2024

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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® Litigation and Generic Entry Outlook for Promacta

A generic version of PROMACTA was approved as eltrombopag olamine by ANNORA PHARMA on April 18th, 2024.

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Drug patent expirations by year for PROMACTA
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Recent Clinical Trials for PROMACTA

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

SponsorPhase
University of California, San FranciscoPhase 1
Food and Drug Administration (FDA)Phase 1
University of California, DavisPhase 1

See all PROMACTA clinical trials

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.

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

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

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 AB 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 AB 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
>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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis PROMACTA eltrombopag olamine TABLET;ORAL 022291-001 Nov 20, 2008 ⤷  Sign Up ⤷  Sign Up
Novartis PROMACTA eltrombopag olamine TABLET;ORAL 022291-005 Nov 16, 2012 ⤷  Sign Up ⤷  Sign Up
Novartis PROMACTA eltrombopag olamine TABLET;ORAL 022291-005 Nov 16, 2012 ⤷  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 022291-005 Nov 16, 2012 ⤷  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
Patent: COMPRIMIDO FARMACEUTICO QUE COMPRENDE LA SAL DE BIS - (MONOETANOLAMINA) DEL ACIDO 3' -[(2Z )-[1-(3,4- DIMETILFENIL)-1,5- DIHIDRO-3- METIL-5 OXO- 4H-PIRAZOL-4- ILIDENO} HIDRAZINO} -2' HIDROXI- { 1,1'- BIFENIL]-3- CARBOXILICO [ELTROMBOPAG OLAMINA), CAPSULA FARMACEUTICA, FORMA DE DOSIFICACION Y GRANULO
Estimated Expiration: ⤷  Sign Up

Patent: 7711
Patent: COMPRIMIDO FARMACÉUTICO, GRÁNULOS FARMACÉUTICOS Y PROCEDIMIENTO PARA SU PREPARACIÓN, FORMA FARMACÉUTICA ORAL SÓLIDA, CÁPSULA
Estimated Expiration: ⤷  Sign Up

Australia

Patent: 07352608
Patent: Novel pharmaceutical composition
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 0721651
Patent: COMPOSIÇÃO FARMACÊUTICA
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 85831
Patent: NOUVELLE COMPOSITION PHARMACEUTIQUE (NOVEL PHARMACEUTICAL COMPOSITION)
Estimated Expiration: ⤷  Sign Up

Chile

Patent: 07002242
Patent: FORMA DE DOSIFICACION FARMACEUTICA ORAL EN COMPRIMIDO, CAPSULA O GRANULO QUE COMPRENDE BIS-(MONOETANOLAMINA) DE ACIDO 3'-[(2Z)-[1-(3,4-DIMETILFENIL)-1,5-DIHIDRO-3-METIL-5-OXO-4H-PIRAZOL-4-ILIDENO]HIDRAZINO]-2'-HIDROXI[1-1'-BIFENIL]-3-CARBOXILICO; PRO
Estimated Expiration: ⤷  Sign Up

China

Patent: 1686930
Patent: Novel pharmaceutical composition
Estimated Expiration: ⤷  Sign Up

Patent: 2688207
Patent: Novel pharmaceutical composition
Estimated Expiration: ⤷  Sign Up

Patent: 2697745
Patent: Novel pharmaceutical composition
Estimated Expiration: ⤷  Sign Up

Colombia

Patent: 60058
Patent: COMPOSICIONES QUE CONTIENEN BIS-(MONOETANOLAMINA) DEL ACIDO 3 ́-[(2Z)-[1-(3,4-DIMETILFENIL)-1,5-DIHIDRO-3-METIL-5-OXO-4H-PIRAZOL-4-ILIDENO]HIDRAZINO]-2 ́HIDROXI-[1,1 ́-BIFENIL]-3-CARBOXILICO (ELTROMBOPAG OLAMINA) Y PROCESOS PARA SU PREPARACION .
Estimated Expiration: ⤷  Sign Up

Costa Rica

Patent: 143
Patent: NUEVA COMPOSICION FARMACEUTICA
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
Patent: COMPOSICION FARMACEUTICA NOVEDOSA
Estimated Expiration: ⤷  Sign Up

Ecuador

Patent: 077628
Patent: NUEVA COMPOSICIÓN FARMACÉUTICA
Estimated Expiration: ⤷  Sign Up

Eurasian Patent Organization

Patent: 0883
Patent: ФАРМАЦЕВТИЧЕСКАЯ ТАБЛЕТКА (PHARMACEUTICAL TABLET)
Estimated Expiration: ⤷  Sign Up

Patent: 4294
Patent: ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ ОЛАМИНА ЭЛЬТРОМБОПАГА (PHARMACEUTICAL COMPOSITION OF ELTROMBOPAG OLAMINE)
Estimated Expiration: ⤷  Sign Up

Patent: 0971018
Patent: НОВАЯ ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ
Estimated Expiration: ⤷  Sign Up

Patent: 1400387
Patent: НОВАЯ ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ
Estimated Expiration: ⤷  Sign Up

Patent: 1991590
Patent: НОВАЯ ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 52237
Patent: NOUVELLE COMPOSITION PHARMACEUTIQUE (NOVEL PHARMACEUTICAL COMPOSITION)
Estimated Expiration: ⤷  Sign Up

Patent: 90730
Patent: NOUVELLE COMPOSITION PHARMACEUTIQUE (NOVEL PHARMACEUTICAL COMPOSITION)
Estimated Expiration: ⤷  Sign Up

Patent: 18732
Patent: COMPRIMÉS COMPRENANTS DE L'ELTROMBOPAG OLAMINE (TABLETS COMPRISING ELTROMBOPAG OLAMINE)
Estimated Expiration: ⤷  Sign Up

Patent: 18733
Patent: COMPRIMÉS COMPRENANTS DE L'ELTROMBOPAG OLAMINE (TABLETS COMPRISING ELTROMBOPAG OLAMINE)
Estimated Expiration: ⤷  Sign Up

Hong Kong

Patent: 36968
Patent: 新穎的藥物組合物 (NOVEL PHARMACEUTICAL COMPOSITION)
Estimated Expiration: ⤷  Sign Up

Hungary

Patent: 27209
Estimated Expiration: ⤷  Sign Up

Israel

Patent: 1891
Patent: טבליות רוקחיות המכילות אלטרומבופאג אולמין, שיטות להכנתן ושימושן בהכנת תרופות לטיפול בתרומבוציטופניה (Pharmaceutical tablets containing eltrombopag olamine, methods for their preparation and use thereof in the preparation of medicaments for treating thrombocytopenia)
Estimated Expiration: ⤷  Sign Up

Patent: 8840
Patent: טבליות רוקחיות המכילות אלטרומבופאג אולמין, שיטות להכנתן ושימושן בהכנת תרופות לטיפול בתרומבוציטופניה (Pharmaceutical tablets containing eltrombopag olamine, methods for their preparation and use thereof in the preparation of medicaments for treating thrombocytopenia)
Estimated Expiration: ⤷  Sign Up

Patent: 4602
Patent: טבליות רוקחיות המכילות אלטרומבופאג אולמין, שיטות להכנתן ושימושן בהכנת תרופות לטיפול בתרומבוציטופניה (Pharmaceutical tablets containing eltrombopag olamine, methods for their preparation and use thereof in the preparation of medicaments for treating thrombocytopenia)
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
Patent: NOVEL PHARMACEUTICAL COMPOSITION
Estimated Expiration: ⤷  Sign Up

Patent: 15129195
Patent: 新たな医薬組成物 (NOVEL PHARMACEUTICAL COMPOSITION)
Estimated Expiration: ⤷  Sign Up

Patent: 17137343
Patent: 新たな医薬組成物 (NOVEL PHARMACEUTICAL COMPOSITION)
Estimated Expiration: ⤷  Sign Up

Patent: 19123747
Patent: 新たな医薬組成物 (NOVEL PHARMACEUTICAL COMPOSITION)
Estimated Expiration: ⤷  Sign Up

Patent: 21100968
Patent: 新たな医薬組成物 (NOVEL PHARMACEUTICAL COMPOSITION)
Estimated Expiration: ⤷  Sign Up

Patent: 23011888
Patent: 新たな医薬組成物
Estimated Expiration: ⤷  Sign Up

Jordan

Patent: 43
Patent: مركبات صيدلانية جديدة (Novel pharmaceutical composition)
Estimated Expiration: ⤷  Sign Up

Malaysia

Patent: 8072
Patent: NOVEL PHAMACEUTICAL COMPOSITION
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 09011881
Patent: NUEVA COMPOSICION FARMACEUTICA. (NOVEL PHARMACEUTICAL COMPOSITION.)
Estimated Expiration: ⤷  Sign Up

Morocco

Patent: 236
Patent: NOUVELLE COMPOSITION PHARMACEUTIQUE
Estimated Expiration: ⤷  Sign Up

New Zealand

Patent: 0888
Patent: Compositions of eltrombopag olamine substantially free from coordinating metals or reducing sugars
Estimated Expiration: ⤷  Sign Up

Peru

Patent: 080773
Patent: COMPOSICION FARMACEUTICA QUE COMPRENDE BIS-(MONOETANOLAMINA) DE ACIDO 3'-[(2Z)-[1-(3,4-DIMETILFENIL)-1,5-DIHIDRO-3-METIL-5-OXO-4H-PIRAZOL-4-ILIDENO]HIDRAZINO]-2'-HIDROXI-[1,1'-BIFENIL]-3-CARBOXILICO
Estimated Expiration: ⤷  Sign Up

Patent: 121407
Patent: COMPOSICION FARMACEUTICA QUE COMPRENDE BIS-(MONOETANOLAMINA) DE ACIDO 3'-[(2Z)-[1-(3, 4-DIMETILFENIL)-1, 5-DIHIDRO-3-METIL-5-OXO-4H-PIRAZOL-4-ILIDENO] HIDRAZINO]-2'-HIDROXI-[1, 1'-BIFENIL]-3-CARBOXILICO
Estimated Expiration: ⤷  Sign Up

Patent: 151953
Patent: COMPOSICION FARMACEUTICA QUE COMPRENDE BIS-(MONOETANOLAMINA) DE ACIDO 3'-[(2Z)-[1-(3, 4-DIMETILFENIL)-1, 5-DIHIDRO-3-METIL-5-OXO-4H-PIRAZOL-4-ILIDENO] HIDRAZINO]-2'-HIDROXI-[1, 1'-BIFENIL]-3-CARBOXILICO
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
Patent: NOVEL PHARMACEUICAL COMPOSITION
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
Patent: NOVEL PHARMACEUTICAL COMPOSITION
Estimated Expiration: ⤷  Sign Up

Patent: 140049086
Patent: NOVEL PHARMACEUTICAL COMPOSITION
Estimated Expiration: ⤷  Sign Up

Patent: 150008513
Patent: NOVEL PHARMACEUTICAL COMPOSITION
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
Patent: Novel pharmaceutical composition
Estimated Expiration: ⤷  Sign Up

Patent: 1410240
Patent: 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
Estimated Expiration: ⤷  Sign Up

Ukraine

Patent: 261
Patent: ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ ЭЛТРОМБОПАГА ОЛАМИНА (ВАРИАНТЫ) И СПОСОБ ЕЕ ИЗГОТОВЛЕНИЯ (ВАРИАНТЫ);ФАРМАЦЕВТИЧНА КОМПОЗИЦІЯ ЕЛТРОМБОПАГУ ОЛАМІНУ (ВАРІАНТИ) І СПОСІБ ЇЇ ВИГОТОВЛЕННЯ (ВАРІАНТИ) (PHARMACEUTICAL COMPOSITIONS CONTAINING ELTROMBOPAG OLAMINE AND PROCESSES FOR THE PREPARATION THEREOF)
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.

Country Patent Number Title Estimated Expiration
Japan 2014005302 NOVEL PHARMACEUTICAL COMPOSITION ⤷  Sign Up
South Korea 101475971 ⤷  Sign Up
Japan 5419866 ⤷  Sign Up
Germany 69837279 ⤷  Sign Up
European Patent Office 3090730 NOUVELLE COMPOSITION PHARMACEUTIQUE (NOVEL PHARMACEUTICAL COMPOSITION) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for PROMACTA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
1534390 C20100006 00032 Estonia ⤷  Sign Up PRODUCT NAME: REVOLADE-ELTROMBOPAG; REG NO/DATE: C(2010)1662 11.03.2010
1294378 SPC/GB10/026 United Kingdom ⤷  Sign Up PRODUCT NAME: ELTROMBOPAG, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE (INCLUDING A HYDRATE); REGISTERED: UK EU1/10/612/001 20100315; UK EU1/10/612/002 20100315; UK EU1/10/612/003 20100315; UK EU1/10/612/004 20100315; UK EU1/10/612/005 20100315; UK EU1/10/612/006 20100315
1294378 388 Finland ⤷  Sign Up
1294378 CA 2010 00017 Denmark ⤷  Sign Up
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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 verification 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.