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PROMACTA KIT Drug Patent Profile

Which patents cover Promacta Kit, and what generic alternatives are available?

Promacta Kit is a drug marketed by Novartis and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has forty-two patent family members in twenty-eight countries.

The generic ingredient in PROMACTA KIT 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 Kit

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

Summary for PROMACTA KIT

International Patents:	42
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	31
DailyMed Link:	PROMACTA KIT at DailyMed

Recent Clinical Trials for PROMACTA KIT

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

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

See all PROMACTA KIT clinical trials

Pharmacology for PROMACTA KIT

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 KIT

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
PROMACTA KIT	For Oral Suspension	eltrombopag olamine	12.5 mg/packet and 25 mg/packet	207027	1	2022-04-22

US Patents and Regulatory Information for PROMACTA KIT

PROMACTA KIT is protected by one 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 KIT	eltrombopag olamine	FOR SUSPENSION;ORAL	207027-002	Sep 27, 2018	AB	RX	Yes	No	7,547,719*PED				Y
Novartis	PROMACTA KIT	eltrombopag olamine	FOR SUSPENSION;ORAL	207027-001	Aug 24, 2015	AB	RX	Yes	Yes
Novartis	PROMACTA KIT	eltrombopag olamine	FOR SUSPENSION;ORAL	207027-002	Sep 27, 2018	AB	RX	Yes	No
Novartis	PROMACTA KIT	eltrombopag olamine	FOR SUSPENSION;ORAL	207027-001	Aug 24, 2015	AB	RX	Yes	Yes	7,547,719*PED				Y

Expired US Patents for PROMACTA KIT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	PROMACTA KIT	eltrombopag olamine	FOR SUSPENSION;ORAL	207027-001	Aug 24, 2015	7,473,686*PED
Novartis	PROMACTA KIT	eltrombopag olamine	FOR SUSPENSION;ORAL	207027-001	Aug 24, 2015	7,160,870*PED
Novartis	PROMACTA KIT	eltrombopag olamine	FOR SUSPENSION;ORAL	207027-002	Sep 27, 2018	7,790,704*PED
Novartis	PROMACTA KIT	eltrombopag olamine	FOR SUSPENSION;ORAL	207027-002	Sep 27, 2018	7,160,870*PED
Novartis	PROMACTA KIT	eltrombopag olamine	FOR SUSPENSION;ORAL	207027-001	Aug 24, 2015	7,795,293*PED
Novartis	PROMACTA KIT	eltrombopag olamine	FOR SUSPENSION;ORAL	207027-001	Aug 24, 2015	7,790,704*PED
Novartis	PROMACTA KIT	eltrombopag olamine	FOR SUSPENSION;ORAL	207027-001	Aug 24, 2015	7,332,481*PED

International Patents for PROMACTA KIT

See the table below for patents covering PROMACTA KIT around the world.

Country	Patent Number	Title	Estimated Expiration
Brazil	PI0310094	composto de bis-(monoetanolamina) de ácido 3'-[(2z)-[1-(3,4-dimetilfenil)-1,5-diidro-3-metil-5-oxo-4h-pirazol-4-ilideno]hidrazino]-2'-hidróxi-[1,1'-bifenil]-3-carboxílico, composição farmacêutica e processos para preparar ditos composto e composição farmacêutica
Lithuania	C1534390
Mexico	PA04011522	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. (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).)
Japan	3813875
Hong Kong	1055561
Malaysia	136707	THROMBOPOIETIN MIMETICS
Spain	2328179

Supplementary Protection Certificates for PROMACTA KIT

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	122010000037	Germany		PRODUCT NAME: ELTROMBOPAG SOWIE PHARMAZEUTISCH ANNEHMBARE SALZE, HYDRATE UND SOLVATE DAVON; NAT. REGISTRATION NO/DATE: EU/1/10/612/001-006 20100311; FIRST REGISTRATION: EU EU/1/10/612/001-/006 20100311
1294378	SPC020/2010	Ireland		SPC020/2010: 20110308, EXPIRES: 20250310
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
1294378	C201000022	Spain		PRODUCT NAME: ELTROMBOPAG; NATIONAL AUTHORISATION NUMBER: EU/1/10/612/001-006; DATE OF AUTHORISATION: 20100315; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/10/612/001-006; DATE OF FIRST AUTHORISATION IN EEA: 20100315
1294378	10C0034	France		PRODUCT NAME: ELTROMBOPAG EVENTUELLEMENT SOUS LA FORME D'UN SEL OU D'UN SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE (INCLUANT UN HYDRATE); REGISTRATION NO/DATE: EU/1/10/612/001 20100315
1294378	C300451	Netherlands		PRODUCT NAME: ELTROMBOPAG, DESGEWENST IN DE; REGISTRATION NO/DATE: EU/1/10/612/001-006 20100311

PROMACTA KIT Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for PROMACTA (Eltrombopag)

Introduction

PROMACTA, also known as eltrombopag, is a small-molecule thrombopoietin (TPO) receptor agonist used to treat low platelet levels in patients with certain blood disorders, including chronic immune thrombocytopenic purpura (ITP), chronic hepatitis C, and aplastic anemia. Here, we delve into the market dynamics and financial trajectory of PROMACTA.

Mechanism of Action and Clinical Use

PROMACTA works by interacting with the transmembrane domain of the human TPO-receptor, initiating signaling cascades that induce the proliferation and differentiation of megakaryocytes from bone marrow progenitor cells. This results in an increase in platelet production, reducing the risk of bleeding in patients with these conditions[4].

Market Segmentation

The market for PROMACTA is segmented based on several factors, including geography, patient population, and dosage.

Geographic Segmentation

The market is analyzed across major regions, including the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan. These regions are critical for understanding the global demand and revenue potential of PROMACTA[4].

Patient Population

PROMACTA is used for various patient populations, including adults and pediatric patients aged 1 year and older with chronic ITP, and those with chronic hepatitis C or aplastic anemia. The dosage varies based on the patient's age and hepatic impairment status[4].

Market Size and Revenue Forecast

The global market for PROMACTA has shown significant growth. Here are some key financial metrics:

Historical Revenue

PROMACTA, launched in 2008, generated substantial revenue for its previous owners. For instance, Ligand Pharmaceuticals earned $291 million in royalties from PROMACTA over 11 years, with annual sales increasing at a compound annual growth rate (CAGR) of 32%[5].

Current and Future Projections

The market forecast for PROMACTA from 2023 to 2032 indicates continued growth. The report by DelveInsight provides a detailed market assessment, including forecasted sales data for the seven major markets. The CAGR for this period is expected to be robust, driven by increasing demand for effective treatments for ITP and other related conditions[4].

Key Factors Affecting the Market

Several factors influence the market dynamics of PROMACTA:

Regulatory Milestones

Regulatory approvals and milestones play a crucial role. For example, the drug's approval for different indications and patient populations expands its market reach. Any changes in regulatory environments can significantly impact the drug's sales and market position[4].

Competitive Landscape

The competitive landscape includes other treatments for ITP and related conditions. Emerging therapies and new market entrants can affect PROMACTA's market share. However, its established position and efficacy have helped it maintain a strong market presence[4].

Dosage and Administration

The dosage of PROMACTA, which varies between 25mg and 50mg depending on the patient population and hepatic impairment, is a critical factor. Adjustments in dosage can impact patient compliance and overall market performance[4].

Financial Performance and Transactions

Royalty and Asset Sales

In 2019, Ligand Pharmaceuticals sold its PROMACTA assets and royalty rights to Royalty Pharma for $827 million. This transaction significantly impacted Ligand's financial guidance, with expected revenues and adjusted diluted EPS adjusted accordingly[5].

Revenue Streams

PROMACTA generates revenue through royalties, material sales, and license fees. For instance, in the first quarter of 2019, Ligand estimated $19 million in royalties, including $15 million from PROMACTA, along with other revenue streams[5].

Market Trends and Drivers

Increasing Prevalence of ITP

The growing prevalence of ITP and other related blood disorders drives the demand for effective treatments like PROMACTA. This trend is expected to continue, contributing to the drug's market growth[4].

Advances in Precision Medicine

The shift towards precision medicine and targeted therapies enhances the market for drugs like PROMACTA, which offer specific and effective treatment options for patients with chronic conditions[3].

Strategic Collaborations and Financing

Companies involved in the development and marketing of PROMACTA often engage in strategic collaborations and financing deals to strengthen their financial positions and expand their market reach. For example, Blueprint Medicines' financing collaborations highlight the importance of strategic financial partnerships in the biotech industry[3].

Challenges and Restraints

Regulatory Hurdles

Changes in regulatory environments and stringent approval processes can pose challenges to the market growth of PROMACTA. Any delays or setbacks in regulatory approvals can impact the drug's revenue and market position[4].

Competition from Emerging Therapies

The emergence of new therapies for ITP and related conditions can pose a competitive threat to PROMACTA. Companies must continuously invest in research and development to maintain market competitiveness[4].

Technological and R&D Trends

Clinical Trials and Research

Ongoing clinical trials and research activities are crucial for expanding the indications and patient populations for PROMACTA. These efforts help in maintaining the drug's market relevance and potential for future growth[4].

Technological Advancements

Advancements in drug delivery systems and precision medicine technologies can enhance the efficacy and compliance of PROMACTA, further solidifying its market position[3].

Regional Analysis

The market for PROMACTA varies significantly across different regions:

North America

The United States is a key market for PROMACTA, driven by a large patient population and a well-established healthcare system. The region is expected to continue contributing significantly to the global revenue of the drug[4].

Europe

The EU4 countries (Germany, France, Italy, and Spain) and the United Kingdom are other significant markets. These regions have a high demand for effective treatments for ITP and related conditions, contributing to the drug's revenue growth[4].

Asia-Pacific

Japan is an important market in the Asia-Pacific region, with a growing demand for targeted therapies like PROMACTA. The region's market dynamics are influenced by local regulatory environments and healthcare policies[4].

Consumer Behavior and Patient Compliance

Patient compliance is a critical factor in the market success of PROMACTA. The drug's oral administration and once-daily dosage regimen contribute to its ease of use and patient compliance. However, factors such as cost, accessibility, and side effects can influence patient behavior and adherence to treatment[4].

SWOT Analysis

Strengths

• Established market presence and efficacy.
• Strong revenue streams through royalties and sales.
• Continuous research and development to expand indications.

Weaknesses

• Dependence on regulatory approvals and milestones.
• Potential competition from emerging therapies.
• Dosage adjustments required for certain patient populations.

Opportunities

• Growing demand for targeted therapies.
• Expanding patient populations and indications.
• Strategic collaborations and financing opportunities.

Threats

• Regulatory changes and hurdles.
• Competition from new market entrants.
• Economic factors affecting healthcare spending.

Key Takeaways

• PROMACTA is a critical treatment for chronic ITP and related conditions, with a strong market presence.
• The drug's market is driven by increasing demand, regulatory milestones, and strategic collaborations.
• Continuous research and development are essential for maintaining market competitiveness.
• Regional market dynamics vary, with North America, Europe, and Asia-Pacific being key regions.
• Patient compliance and regulatory environments are crucial factors influencing the drug's market performance.

FAQs

What is PROMACTA used for?

PROMACTA (eltrombopag) is used to treat low platelet levels in patients with chronic immune thrombocytopenic purpura (ITP), chronic hepatitis C, and aplastic anemia.

How does PROMACTA work?

PROMACTA works by interacting with the TPO-receptor, initiating signaling cascades that induce the proliferation and differentiation of megakaryocytes, thereby increasing platelet production.

What are the key regions for the PROMACTA market?

The key regions include North America (the United States), Europe (EU4 countries and the United Kingdom), and the Asia-Pacific region (Japan).

What are the main factors driving the PROMACTA market?

The main factors include increasing demand for targeted therapies, regulatory milestones, and strategic collaborations. Additionally, the growing prevalence of ITP and related conditions drives the market.

What are the potential challenges for the PROMACTA market?

Potential challenges include regulatory hurdles, competition from emerging therapies, and economic factors affecting healthcare spending.

Sources

1. Cognitivemarketresearch.com: Promacta Market Report 2024 (Global Edition)
2. Amgen Investors: SHAREHOLDERS - Investors | Amgen Inc.
3. PR Newswire: Blueprint Medicines Announces Transformative $1.25 Billion Strategic Financing Collaborations
4. GII Research: PROMACTA Drug Insight and Market Forecast - 2032
5. Business Wire: Ligand Sells Promacta Assets and Royalty for $827 Million