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Last Updated: October 1, 2022

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 seventy-eight 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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Summary for PROMACTA
Drug patent expirations by year for PROMACTA
Drug Prices for PROMACTA

See drug prices for PROMACTA

DrugPatentWatch® Estimated Generic Entry Opportunity 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 two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of PROMACTA is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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: See Plans and Pricing

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: See Plans and Pricing

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis PROMACTA eltrombopag olamine TABLET;ORAL 022291-005 Nov 16, 2012 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Novartis PROMACTA eltrombopag olamine TABLET;ORAL 022291-003 Sep 8, 2009 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Novartis PROMACTA KIT eltrombopag olamine FOR SUSPENSION;ORAL 207027-002 Sep 27, 2018 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Novartis PROMACTA eltrombopag olamine TABLET;ORAL 022291-005 Nov 16, 2012 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 022291-003 Sep 8, 2009 See Plans and Pricing See Plans and Pricing
Novartis PROMACTA eltrombopag olamine TABLET;ORAL 022291-005 Nov 16, 2012 See Plans and Pricing See Plans and Pricing
Novartis PROMACTA eltrombopag olamine TABLET;ORAL 022291-002 Nov 20, 2008 See Plans and Pricing See Plans and Pricing
Novartis PROMACTA eltrombopag olamine TABLET;ORAL 022291-002 Nov 20, 2008 See Plans and Pricing See Plans and Pricing
>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: See Plans and Pricing

Patent: 7711
Estimated Expiration: See Plans and Pricing

Australia

Patent: 07352608
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0721651
Estimated Expiration: See Plans and Pricing

Canada

Patent: 85831
Estimated Expiration: See Plans and Pricing

Chile

Patent: 07002242
Estimated Expiration: See Plans and Pricing

China

Patent: 1686930
Estimated Expiration: See Plans and Pricing

Patent: 2688207
Estimated Expiration: See Plans and Pricing

Patent: 2697745
Estimated Expiration: See Plans and Pricing

Colombia

Patent: 60058
Estimated Expiration: See Plans and Pricing

Costa Rica

Patent: 143
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0160206
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 17284
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 52237
Estimated Expiration: See Plans and Pricing

Dominican Republic

Patent: 009000253
Estimated Expiration: See Plans and Pricing

Ecuador

Patent: 077628
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 0883
Estimated Expiration: See Plans and Pricing

Patent: 4294
Estimated Expiration: See Plans and Pricing

Patent: 0971018
Estimated Expiration: See Plans and Pricing

Patent: 1400387
Estimated Expiration: See Plans and Pricing

Patent: 1991590
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 52237
Estimated Expiration: See Plans and Pricing

Patent: 90730
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 36968
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 27209
Estimated Expiration: See Plans and Pricing

Israel

Patent: 1891
Estimated Expiration: See Plans and Pricing

Patent: 8840
Estimated Expiration: See Plans and Pricing

Patent: 4602
Estimated Expiration: See Plans and Pricing

Japan

Patent: 19866
Estimated Expiration: See Plans and Pricing

Patent: 35078
Estimated Expiration: See Plans and Pricing

Patent: 44713
Estimated Expiration: See Plans and Pricing

Patent: 60289
Estimated Expiration: See Plans and Pricing

Patent: 10526140
Estimated Expiration: See Plans and Pricing

Patent: 14005302
Estimated Expiration: See Plans and Pricing

Patent: 15129195
Estimated Expiration: See Plans and Pricing

Patent: 17137343
Estimated Expiration: See Plans and Pricing

Patent: 19123747
Estimated Expiration: See Plans and Pricing

Patent: 21100968
Estimated Expiration: See Plans and Pricing

Jordan

Patent: 43
Estimated Expiration: See Plans and Pricing

Malaysia

Patent: 8072
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 09011881
Estimated Expiration: See Plans and Pricing

Morocco

Patent: 236
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 0888
Estimated Expiration: See Plans and Pricing

Peru

Patent: 080773
Estimated Expiration: See Plans and Pricing

Patent: 121407
Estimated Expiration: See Plans and Pricing

Patent: 151953
Estimated Expiration: See Plans and Pricing

Poland

Patent: 52237
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 52237
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 52237
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 0907710
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1475971
Estimated Expiration: See Plans and Pricing

Patent: 1537200
Estimated Expiration: See Plans and Pricing

Patent: 1632851
Estimated Expiration: See Plans and Pricing

Patent: 100020456
Estimated Expiration: See Plans and Pricing

Patent: 140049086
Estimated Expiration: See Plans and Pricing

Patent: 150008513
Estimated Expiration: See Plans and Pricing

Spain

Patent: 65179
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 39267
Estimated Expiration: See Plans and Pricing

Patent: 38674
Estimated Expiration: See Plans and Pricing

Patent: 0843742
Estimated Expiration: See Plans and Pricing

Patent: 1410240
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 261
Estimated Expiration: See Plans and Pricing

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
Slovenia 1534390 See Plans and Pricing
Poland 359270 See Plans and Pricing
Israel 193618 See Plans and Pricing
Japan 2010265317 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) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for PROMACTA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1294378 CA 2010 00017 Denmark See Plans and Pricing
1294378 C01294378/01 Switzerland See Plans and Pricing FORMER OWNER: GLAXOSMITHKLINE LLC, US
1534390 PA2010007,C1534390 Lithuania See Plans and Pricing 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 91 3-2010 Slovakia See Plans and Pricing PRODUCT NAME: ELTROMBOPAG; REGISTRATION NO/DATE: EU/1/10/612/001 - EU/1/10/612/006 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.