PROMACTA Drug Patent Profile

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 18^th, 2024.

Summary for PROMACTA

International Patents:	123
US Patents:	6
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	72
Clinical Trials:	31
Patent Applications:	249
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

See drug prices for PROMACTA

Recent Clinical Trials for PROMACTA

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

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

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.

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	022291-003	Sep 8, 2009	AB	RX	Yes	Yes
Novartis	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-005	Nov 16, 2012		DISCN	Yes	No	7,547,719*PED				Y
Novartis	PROMACTA KIT	eltrombopag olamine	FOR SUSPENSION;ORAL	207027-001	Aug 24, 2015	AB	RX	Yes	Yes	7,547,719*PED				Y
Novartis	PROMACTA KIT	eltrombopag olamine	FOR SUSPENSION;ORAL	207027-002	Sep 27, 2018	AB	RX	Yes	No

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	7,160,870*PED
Novartis	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-005	Nov 16, 2012	6,280,959*PED
Novartis	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-005	Nov 16, 2012	7,332,481*PED
Novartis	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-002	Nov 20, 2008	6,280,959*PED

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

Australia

Brazil

Canada

Chile

China

Colombia

Costa Rica

Croatia

Cyprus

Denmark

Dominican Republic

Ecuador

Eurasian Patent Organization

European Patent Office

Hong Kong

Hungary

Israel

Japan

Jordan

Malaysia

Mexico

Morocco

New Zealand

Peru

Poland

Portugal

Slovenia

South Africa

South Korea

Spain

Taiwan

Ukraine

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
Hungary	230487	Thrombopoetin mimetikumok (Thrombopoetin mimetics)
Norway	324246
Spain	2294000
Spain	2328179

Supplementary Protection Certificates for PROMACTA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1294378	2010C/018	Belgium		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		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		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		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

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]