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Last Updated: February 26, 2024

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 eight patents protecting this drug and two Paragraph IV challenges.

This drug has one hundred and eighty-one patent family members in forty-two 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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Drug patent expirations by year for PROMACTA
Drug Prices for PROMACTA

See drug prices for PROMACTA

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for PROMACTA
Generic Entry Date for PROMACTA*:
Constraining patent/regulatory exclusivity:
NDA:
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

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 eight US patents and one FDA Regulatory Exclusivity.

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

This potential generic entry date is based on patent ⤷  Try a Trial.

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

Thrombopoietin mimetics
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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: ⤷  Try a Trial

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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Novartis PROMACTA eltrombopag olamine TABLET;ORAL 022291-003 Sep 8, 2009 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Novartis PROMACTA KIT eltrombopag olamine FOR SUSPENSION;ORAL 207027-001 Aug 24, 2015 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Novartis PROMACTA eltrombopag olamine TABLET;ORAL 022291-003 Sep 8, 2009 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Novartis PROMACTA eltrombopag olamine TABLET;ORAL 022291-003 Sep 8, 2009 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Novartis PROMACTA eltrombopag olamine TABLET;ORAL 022291-003 Sep 8, 2009 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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 PROMACTA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis PROMACTA eltrombopag olamine TABLET;ORAL 022291-005 Nov 16, 2012 ⤷  Try a Trial ⤷  Try a Trial
Novartis PROMACTA eltrombopag olamine TABLET;ORAL 022291-002 Nov 20, 2008 ⤷  Try a Trial ⤷  Try a Trial
Novartis PROMACTA eltrombopag olamine TABLET;ORAL 022291-003 Sep 8, 2009 ⤷  Try a Trial ⤷  Try a Trial
Novartis PROMACTA eltrombopag olamine TABLET;ORAL 022291-004 Oct 20, 2011 ⤷  Try a Trial ⤷  Try a Trial
Novartis PROMACTA eltrombopag olamine TABLET;ORAL 022291-005 Nov 16, 2012 ⤷  Try a Trial ⤷  Try a Trial
Novartis PROMACTA eltrombopag olamine TABLET;ORAL 022291-004 Oct 20, 2011 ⤷  Try a Trial ⤷  Try a Trial
>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: ⤷  Try a Trial

Patent: 7711
Estimated Expiration: ⤷  Try a Trial

Australia

Patent: 07352608
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 0721651
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 85831
Estimated Expiration: ⤷  Try a Trial

Chile

Patent: 07002242
Estimated Expiration: ⤷  Try a Trial

China

Patent: 1686930
Estimated Expiration: ⤷  Try a Trial

Patent: 2688207
Estimated Expiration: ⤷  Try a Trial

Patent: 2697745
Estimated Expiration: ⤷  Try a Trial

Colombia

Patent: 60058
Estimated Expiration: ⤷  Try a Trial

Costa Rica

Patent: 143
Estimated Expiration: ⤷  Try a Trial

Croatia

Patent: 0160206
Estimated Expiration: ⤷  Try a Trial

Cyprus

Patent: 17284
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 52237
Estimated Expiration: ⤷  Try a Trial

Dominican Republic

Patent: 009000253
Estimated Expiration: ⤷  Try a Trial

Ecuador

Patent: 077628
Estimated Expiration: ⤷  Try a Trial

Eurasian Patent Organization

Patent: 0883
Estimated Expiration: ⤷  Try a Trial

Patent: 4294
Estimated Expiration: ⤷  Try a Trial

Patent: 0971018
Estimated Expiration: ⤷  Try a Trial

Patent: 1400387
Estimated Expiration: ⤷  Try a Trial

Patent: 1991590
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 52237
Estimated Expiration: ⤷  Try a Trial

Patent: 90730
Estimated Expiration: ⤷  Try a Trial

Patent: 18732
Estimated Expiration: ⤷  Try a Trial

Patent: 18733
Estimated Expiration: ⤷  Try a Trial

Hong Kong

Patent: 36968
Estimated Expiration: ⤷  Try a Trial

Hungary

Patent: 27209
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 1891
Estimated Expiration: ⤷  Try a Trial

Patent: 8840
Estimated Expiration: ⤷  Try a Trial

Patent: 4602
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 19866
Estimated Expiration: ⤷  Try a Trial

Patent: 35078
Estimated Expiration: ⤷  Try a Trial

Patent: 44713
Estimated Expiration: ⤷  Try a Trial

Patent: 60289
Estimated Expiration: ⤷  Try a Trial

Patent: 10526140
Estimated Expiration: ⤷  Try a Trial

Patent: 14005302
Estimated Expiration: ⤷  Try a Trial

Patent: 15129195
Estimated Expiration: ⤷  Try a Trial

Patent: 17137343
Estimated Expiration: ⤷  Try a Trial

Patent: 19123747
Estimated Expiration: ⤷  Try a Trial

Patent: 21100968
Estimated Expiration: ⤷  Try a Trial

Patent: 23011888
Estimated Expiration: ⤷  Try a Trial

Jordan

Patent: 43
Estimated Expiration: ⤷  Try a Trial

Malaysia

Patent: 8072
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 09011881
Estimated Expiration: ⤷  Try a Trial

Morocco

Patent: 236
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 0888
Estimated Expiration: ⤷  Try a Trial

Peru

Patent: 080773
Estimated Expiration: ⤷  Try a Trial

Patent: 121407
Estimated Expiration: ⤷  Try a Trial

Patent: 151953
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 52237
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 52237
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 52237
Estimated Expiration: ⤷  Try a Trial

South Africa

Patent: 0907710
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 1475971
Estimated Expiration: ⤷  Try a Trial

Patent: 1537200
Estimated Expiration: ⤷  Try a Trial

Patent: 1632851
Estimated Expiration: ⤷  Try a Trial

Patent: 100020456
Estimated Expiration: ⤷  Try a Trial

Patent: 140049086
Estimated Expiration: ⤷  Try a Trial

Patent: 150008513
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 65179
Estimated Expiration: ⤷  Try a Trial

Taiwan

Patent: 39267
Estimated Expiration: ⤷  Try a Trial

Patent: 38674
Estimated Expiration: ⤷  Try a Trial

Patent: 0843742
Estimated Expiration: ⤷  Try a Trial

Patent: 1410240
Estimated Expiration: ⤷  Try a Trial

Ukraine

Patent: 261
Estimated Expiration: ⤷  Try a Trial

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
South Africa 200408701 3'-Ä2Z)-Ä1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-ylideneÜhy-drazinoÜ-2-hydroxy-Ä1,1'-biphenylÜ-3-carboxylic acid bis-(monoethanolamine). ⤷  Try a Trial
Japan 3813875 ⤷  Try a Trial
Hungary 230387 TPO mimetikumként alkalmazható 3-{N'-[1-(3,4-dimetil-fenil)-3-metil-5-oxo-1,5-dihidro-4-pirazolilidén]- hidrazino}-2-hidroxi-3'-(5-tetrazolil)-bifenil (3-{n'-[1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1,5-dihydropyrazol-4-ylidene]hydrazino}-2-hydroxy-3'-(tetrazol-5-yl)biphenyl useful as tpo-mimetic) ⤷  Try a Trial
European Patent Office 2206533 Bis-(monoéthanolamine) de l'acide 3'- (2z)- 1-(3,4-diméthylphenyl)-1,5-dihydro-3-méthyl-5-oxo-4h-pyrazol-4-ylidène hydrazino -2'-hydroxy- 1,1'-biphényl -3-carboxylique (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)) ⤷  Try a Trial
Iceland 2770 ⤷  Try a Trial
Japan 2015129195 新たな医薬組成物 (NOVEL PHARMACEUTICAL COMPOSITION) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for PROMACTA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1294378 SPC020/2010 Ireland ⤷  Try a Trial SPC020/2010: 20110308, EXPIRES: 20250310
1294378 2010/020 Ireland ⤷  Try a Trial PRODUCT NAME: ELTROMBOPAG, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE (INCLUDING A HYDRATE).; REGISTRATION NO/DATE: EU/1/10/612/001-006 20100311
1534390 91 3-2010 Slovakia ⤷  Try a Trial PRODUCT NAME: ELTROMBOPAG; REGISTRATION NO/DATE: EU/1/10/612/001 - EU/1/10/612/006 20100315
1534390 PA2010007,C1534390 Lithuania ⤷  Try a Trial PRODUCT NAME: ELTROMBOPAGO OLAMINAS; 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 C 2010 013 Romania ⤷  Try a Trial PRODUCT NAME: ELTROMBOPAG; NATIONAL AUTHORISATION NUMBER: RO EU/1/10/612/001, RO EU/1/10/612/002, RO EU/1/10/612/003, RO EU/1/10/612/004, RO EU/1/10/612/005, RO EU/1/10/612/006; DATE OF NATIONAL AUTHORISATION: 20100311; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/10/612/001, EMEA EU/1/10/612/002, EMEA EU/1/10/612/003, EMEA EU/1/10/612/004, EMEA EU/1/10/612/005, EMEA EU/1/10/612/006; DATE OF FIRST AUTHORISATION IN EEA: 20100311
1294378 300451 Netherlands ⤷  Try a Trial PRODUCT NAME: ELTROMBOPAG, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT (MET INBEGRIP VAN EEN HYDRAAT), IN HET BIJZONDER ELTROMBOPAG OLAMINE; REGISTRATION NO/DATE: EU/1/10/612/001-006 20100315
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
McKesson
Moodys
Johnson and Johnson
Express Scripts
Baxter

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.