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Last Updated: March 17, 2025

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 twenty-three patent family members in forty-one 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
Drug Prices for PROMACTA

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Recent Clinical Trials for PROMACTA

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

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Novartis PROMACTA eltrombopag olamine TABLET;ORAL 022291-003 Sep 8, 2009 AB RX Yes Yes ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Novartis PROMACTA eltrombopag olamine TABLET;ORAL 022291-005 Nov 16, 2012 DISCN Yes No 7,547,719*PED ⤷  Try for Free Y ⤷  Try for Free
Novartis PROMACTA KIT eltrombopag olamine FOR SUSPENSION;ORAL 207027-001 Aug 24, 2015 AB RX Yes Yes 7,547,719*PED ⤷  Try for Free Y ⤷  Try for Free
Novartis PROMACTA KIT eltrombopag olamine FOR SUSPENSION;ORAL 207027-002 Sep 27, 2018 AB RX Yes No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 4 of 4 entries

Expired US Patents for PROMACTA

ApplicantTradenameGeneric NameDosageNDAApproval DatePatent No.Patent Expiration
Novartis PROMACTA eltrombopag olamine TABLET;ORAL 022291-003 Sep 8, 2009 7,160,870*PED ⤷  Try for Free
Novartis PROMACTA eltrombopag olamine TABLET;ORAL 022291-005 Nov 16, 2012 6,280,959*PED ⤷  Try for Free
Novartis PROMACTA eltrombopag olamine TABLET;ORAL 022291-005 Nov 16, 2012 7,332,481*PED ⤷  Try for Free
Novartis PROMACTA eltrombopag olamine TABLET;ORAL 022291-002 Nov 20, 2008 6,280,959*PED ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>Patent No.>Patent Expiration
Showing 1 to 4 of 4 entries

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 for Free

Patent: 7711
Estimated Expiration: ⤷  Try for Free

Australia

Patent: 07352608
Patent: Novel pharmaceutical composition
Estimated Expiration: ⤷  Try for Free

Brazil

Patent: 0721651
Estimated Expiration: ⤷  Try for Free

Canada

Patent: 85831
Estimated Expiration: ⤷  Try for Free

Chile

Patent: 07002242
Estimated Expiration: ⤷  Try for Free

China

Patent: 1686930
Estimated Expiration: ⤷  Try for Free

Patent: 2688207
Estimated Expiration: ⤷  Try for Free

Patent: 2697745
Estimated Expiration: ⤷  Try for Free

Colombia

Patent: 60058
Estimated Expiration: ⤷  Try for Free

Costa Rica

Patent: 143
Estimated Expiration: ⤷  Try for Free

Croatia

Patent: 0160206
Estimated Expiration: ⤷  Try for Free

Cyprus

Patent: 17284
Estimated Expiration: ⤷  Try for Free

Denmark

Patent: 52237
Estimated Expiration: ⤷  Try for Free

Dominican Republic

Patent: 009000253
Estimated Expiration: ⤷  Try for Free

Ecuador

Patent: 077628
Estimated Expiration: ⤷  Try for Free

Eurasian Patent Organization

Patent: 0883
Estimated Expiration: ⤷  Try for Free

Patent: 4294
Estimated Expiration: ⤷  Try for Free

Patent: 0971018
Estimated Expiration: ⤷  Try for Free

Patent: 1400387
Estimated Expiration: ⤷  Try for Free

Patent: 1991590
Estimated Expiration: ⤷  Try for Free

European Patent Office

Patent: 52237
Estimated Expiration: ⤷  Try for Free

Patent: 90730
Estimated Expiration: ⤷  Try for Free

Patent: 18732
Estimated Expiration: ⤷  Try for Free

Patent: 18733
Estimated Expiration: ⤷  Try for Free

Hong Kong

Patent: 36968
Estimated Expiration: ⤷  Try for Free

Hungary

Patent: 27209
Estimated Expiration: ⤷  Try for Free

Israel

Patent: 1891
Estimated Expiration: ⤷  Try for Free

Patent: 8840
Estimated Expiration: ⤷  Try for Free

Patent: 4602
Estimated Expiration: ⤷  Try for Free

Japan

Patent: 19866
Estimated Expiration: ⤷  Try for Free

Patent: 35078
Estimated Expiration: ⤷  Try for Free

Patent: 44713
Estimated Expiration: ⤷  Try for Free

Patent: 60289
Estimated Expiration: ⤷  Try for Free

Patent: 10526140
Estimated Expiration: ⤷  Try for Free

Patent: 14005302
Estimated Expiration: ⤷  Try for Free

Patent: 15129195
Estimated Expiration: ⤷  Try for Free

Patent: 17137343
Estimated Expiration: ⤷  Try for Free

Patent: 19123747
Estimated Expiration: ⤷  Try for Free

Patent: 21100968
Estimated Expiration: ⤷  Try for Free

Patent: 23011888
Estimated Expiration: ⤷  Try for Free

Jordan

Patent: 43
Estimated Expiration: ⤷  Try for Free

Malaysia

Patent: 8072
Estimated Expiration: ⤷  Try for Free

Mexico

Patent: 09011881
Estimated Expiration: ⤷  Try for Free

Morocco

Patent: 236
Estimated Expiration: ⤷  Try for Free

New Zealand

Patent: 0888
Estimated Expiration: ⤷  Try for Free

Peru

Patent: 080773
Estimated Expiration: ⤷  Try for Free

Patent: 121407
Estimated Expiration: ⤷  Try for Free

Patent: 151953
Estimated Expiration: ⤷  Try for Free

Poland

Patent: 52237
Estimated Expiration: ⤷  Try for Free

Portugal

Patent: 52237
Estimated Expiration: ⤷  Try for Free

Slovenia

Patent: 52237
Estimated Expiration: ⤷  Try for Free

South Africa

Patent: 0907710
Estimated Expiration: ⤷  Try for Free

South Korea

Patent: 1475971
Estimated Expiration: ⤷  Try for Free

Patent: 1537200
Estimated Expiration: ⤷  Try for Free

Patent: 1632851
Estimated Expiration: ⤷  Try for Free

Patent: 100020456
Estimated Expiration: ⤷  Try for Free

Patent: 140049086
Estimated Expiration: ⤷  Try for Free

Patent: 150008513
Estimated Expiration: ⤷  Try for Free

Spain

Patent: 65179
Estimated Expiration: ⤷  Try for Free

Taiwan

Patent: 39267
Estimated Expiration: ⤷  Try for Free

Patent: 38674
Estimated Expiration: ⤷  Try for Free

Patent: 0843742
Estimated Expiration: ⤷  Try for Free

Patent: 1410240
Estimated Expiration: ⤷  Try for Free

Ukraine

Patent: 261
Estimated Expiration: ⤷  Try for Free

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.

CountryPatent NumberTitleEstimated Expiration
Hungary 230487 Thrombopoetin mimetikumok (Thrombopoetin mimetics) ⤷  Try for Free
Norway 324246 ⤷  Try for Free
Spain 2294000 ⤷  Try for Free
Spain 2328179 ⤷  Try for Free
>Country>Patent Number>Title>Estimated Expiration
Showing 1 to 4 of 4 entries

Supplementary Protection Certificates for PROMACTA

Patent NumberSupplementary Protection CertificateSPC CountrySPC ExpirationSPC Description
1294378 2010C/018 Belgium ⤷  Try for Free 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
1294378 23/2010 Austria ⤷  Try for Free PRODUCT NAME: ELTROMBOPAG, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, HYDRATS UND SOLVATS DAVON; REGISTRATION NO/DATE: EU/1/10/612/001-EU/1/10/612/006 (MITTEILUNG) 20100315
1534390 C 2010 013 Romania ⤷  Try for Free 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 SPC/GB10/026 United Kingdom ⤷  Try for Free 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
>Patent Number>Supplementary Protection Certificate>SPC Country>SPC Expiration>SPC Description
Showing 1 to 4 of 4 entries

Market Dynamics and Financial Trajectory for Promacta

Introduction to Promacta

Promacta, also known as eltrombopag, is a thrombopoietin receptor agonist used to treat various platelet disorders, including chronic immune thrombocytopenic purpura (ITP), severe aplastic anemia (SAA), and thrombocytopenia associated with chronic hepatitis C. Developed by Novartis, Promacta has seen significant growth and expansion in its market presence.

Market Growth Drivers

The Promacta market is driven by several key factors:

Increasing Prevalence of Platelet Disorders

The rising incidence of chronic immune thrombocytopenic purpura (ITP) and other platelet disorders is a major driver. ITP affects 4.5 to 10 per 100,000 adults annually, creating a substantial demand for targeted therapies like Promacta[3].

Expanding Indications

Promacta's initial approval for ITP has been followed by approvals for other conditions such as aplastic anemia and hepatitis C-related thrombocytopenia. This diversification of indications has enhanced its therapeutic profile and attracted a wider patient demographic[3][4].

Regulatory Approvals and Flexibility

The FDA has granted Promacta several approvals, including a breakthrough designation for treating acute radiation syndrome. Expedited pathways for rare diseases have also facilitated its market entry and expansion[3][4].

Technological Advancements and Personalized Medicine

Advancements in biopharmaceutical manufacturing and the integration of technologies like artificial intelligence in drug discovery are expected to enhance Promacta's efficacy and explore new indications[3].

Financial Performance and Projections

Current Market Size and Growth Rate

The Promacta market was valued at USD 7.7 billion in 2023 and is projected to reach USD 13.9 billion by 2031, growing at a compound annual growth rate (CAGR) of 7.5% from 2024 to 2031[1].

Revenue Growth

Sales of Promacta have shown significant growth, with a 37% year-over-year increase to $844 million in the first nine months of 2018. In 2022, Promacta/Revolade generated USD 540 million, with an 11% growth in constant currency[4][5].

Segmental Analysis

The market is segmented based on application (thrombocytopenia treatment, immune thrombocytopenia, chronic hepatitis C treatment, aplastic anemia treatment) and product (eltrombopag tablets, eltrombopag oral suspension), with geographical regions also playing a crucial role in market dynamics[1].

Geographical Market Dynamics

Emerging Markets

Emerging markets, particularly in the Asia-Pacific region, offer significant growth opportunities. Countries like China and India are experiencing improvements in healthcare infrastructure and rising disposable incomes, leading to increased healthcare spending and earlier diagnoses of chronic diseases[3].

Regional Regulatory Landscapes

The regulatory landscape varies across regions, with the FDA in the U.S. offering streamlined processes for novel therapies, while other countries may have more stringent approval protocols. This variability can impact the timely access to Promacta and its market growth[3].

Challenges and Complications

Regulatory Hurdles

The diverse regulatory environments across different regions pose a significant challenge. While the FDA has expedited pathways, other countries may impose stringent approval protocols that delay market entry[3].

Cost and Healthcare Budgets

The rising cost of healthcare and the emphasis on cost-effective treatments can sideline innovative therapies like Promacta. Health technology assessments in countries like Germany and the UK rigorously evaluate the economic value of new medications, complicating market dynamics[3].

Value-Based Pricing Models

The introduction of value-based pricing models requires pharmaceutical companies to demonstrate the economic value of Promacta, not just its clinical benefits. This shift necessitates collaboration with healthcare providers and payers to gather real-world evidence to substantiate pricing strategies[3].

Future Outlook and Research

Ongoing Clinical Trials and New Indications

Ongoing clinical trials are investigating Promacta's potential in various hematologic conditions, such as myelodysplastic syndromes. These efforts are expected to broaden its therapeutic landscape and solidify its market position[1][3].

Technological Integration

The integration of advanced technologies, such as artificial intelligence in drug discovery, could expedite the identification of new indications and optimize treatment protocols, further enhancing Promacta’s market potential[3].

Strategic Alliances and Manufacturing Improvements

Collaborative Efforts

Strategic alliances between pharmaceutical companies and research institutions are crucial for exploring new formulations and combinations that enhance the drug’s efficacy. These collaborations are expected to drive long-term market growth[1][3].

Biopharmaceutical Manufacturing

Improvements in biopharmaceutical manufacturing are also anticipated to support market expansion. These advancements can lead to more efficient production processes and better product quality, further solidifying Promacta’s position in the market[1].

Key Takeaways

  • Promacta's market growth is driven by increasing prevalence of platelet disorders, expanding treatment indications, and regulatory approvals.
  • The market is projected to grow at a CAGR of 7.5% from 2024 to 2031, reaching USD 13.9 billion by 2031.
  • Emerging markets, especially in Asia-Pacific, present significant growth opportunities.
  • Regulatory and cost challenges, including value-based pricing models, need to be navigated for sustained market growth.
  • Ongoing research and technological integration are expected to enhance Promacta’s therapeutic profile and market position.

FAQs

Q: What is Promacta used for? Promacta, or eltrombopag, is used to treat various platelet disorders, including chronic immune thrombocytopenic purpura (ITP), severe aplastic anemia (SAA), and thrombocytopenia associated with chronic hepatitis C.

Q: What is the current market size of Promacta? The Promacta market was valued at USD 7.7 billion in 2023.

Q: What is the projected growth rate of the Promacta market? The Promacta market is expected to grow at a CAGR of 7.5% from 2024 to 2031.

Q: Which regions offer significant growth opportunities for Promacta? Emerging markets, particularly in the Asia-Pacific region, offer significant growth opportunities due to improvements in healthcare infrastructure and rising disposable incomes.

Q: What are the main challenges facing the Promacta market? The main challenges include regulatory hurdles, rising healthcare costs, and the need to demonstrate economic value under value-based pricing models.

Cited Sources

  1. Market Research Intellect - Promacta Market Size and Projections[1]
  2. Novartis Financial Results Q4 2023 - Novartis Financial Results[2]
  3. PMarketResearch - Worldwide Promacta Market Research 2024[3]
  4. FiercePharma - Novartis scores FDA nod for Promacta label expansion[4]
  5. Novartis Financial Results Q4 2022 - Novartis Financial Results[5]

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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.