ELTROMBOPAG CHOLINE - Generic Drug Details

What are the generic drug sources for eltrombopag choline and what is the scope of patent protection?

Eltrombopag choline is the generic ingredient in one branded drug marketed by Teva Pharms Inc and is included in one NDA. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Eltrombopag choline has two patent family members in two countries.

One supplier is listed for this compound.

Summary for ELTROMBOPAG CHOLINE

International Patents:	2
US Patents:	1
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
DailyMed Link:	ELTROMBOPAG CHOLINE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ELTROMBOPAG CHOLINE

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.

Pharmacology for ELTROMBOPAG CHOLINE

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

Anatomical Therapeutic Chemical (ATC) Classes for ELTROMBOPAG CHOLINE

B02BX	Other systemic hemostatics
B02B	VITAMIN K AND OTHER HEMOSTATICS
B02	ANTIHEMORRHAGICS
B	Blood and blood forming organs

US Patents and Regulatory Information for ELTROMBOPAG CHOLINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Teva Pharms Inc	ALVAIZ	eltrombopag choline	TABLET;ORAL	216774-002	Nov 29, 2023		RX	Yes	No			Y	Y
Teva Pharms Inc	ALVAIZ	eltrombopag choline	TABLET;ORAL	216774-001	Nov 29, 2023		RX	Yes	No			Y	Y
Teva Pharms Inc	ALVAIZ	eltrombopag choline	TABLET;ORAL	216774-003	Nov 29, 2023		RX	Yes	No			Y	Y
Teva Pharms Inc	ALVAIZ	eltrombopag choline	TABLET;ORAL	216774-004	Nov 29, 2023		RX	Yes	Yes			Y	Y

International Patents for ELTROMBOPAG CHOLINE

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3692021	FORMES À L'ÉTAT SOLIDE D'ELTROMBOPAG CHOLINE (SOLID STATE FORMS OF ELTROMBOPAG CHOLINE)
World Intellectual Property Organization (WIPO)	2019071111

Supplementary Protection Certificates for ELTROMBOPAG CHOLINE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1294378	2010/020	Ireland		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
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	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
1294378	300451	Netherlands		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

ELTROMBOPAG CHOLINE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Eltrombopag Choline

Market Overview

The market for eltrombopag, including its choline salt form, is experiencing significant growth driven by increasing demand in various therapeutic areas. Here are the key dynamics and financial projections for eltrombopag choline.

Market Size and Growth

The global eltrombopag drugs market, which includes eltrombopag choline, was estimated to be around USD 2.28 billion in 2023. It is projected to grow to USD 5.28 billion by 2034, with a compound annual growth rate (CAGR) of 7.94% from 2024 to 2034[1].

Therapeutic Applications

Eltrombopag choline is used for several critical therapeutic applications:

• Chronic Immune Thrombocytopenia (ITP): It is prescribed for patients with persistent or chronic ITP who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy[4].
• Chronic Hepatitis C: It allows the initiation and maintenance of interferon-based therapy in patients with chronic hepatitis C by managing thrombocytopenia[4].
• Severe Aplastic Anemia: It is used in patients who have had an insufficient response to immunosuppressive therapy[4].

Regional Market Performance

North America

North America dominated the eltrombopag drugs market in 2023, driven by growing research, cooperation from major industry participants, government support, and investments in healthcare services. The U.S. and Canada are the primary countries driving this market forward[1].

Asia Pacific

The Asia Pacific region is also experiencing rapid growth due to increased foreign investment and cooperation among various players. The large population in this region provides a significant advantage in terms of market potential[1].

Product Forms and Administration

Oral Administration

The tablets segment held a significant share of the eltrombopag drugs market in 2023. Oral administration is preferred due to its ease of use, affordability, painlessness, high patient compliance rate, and variety of dose forms. For oral administration, the drug must be significantly soluble in water, which enhances bioavailability[1].

Bioequivalence and Formulations

Eltrombopag choline tablets have been shown to be bioequivalent to the existing eltrombopag olamine tablets (Promacta) in certain strengths. For example, the 54 mg eltrombopag choline tablet is bioequivalent to the 75 mg Promacta tablet under fasted conditions[2][4].

Financial Performance

Revenue and Growth

In 2023, Novartis, the manufacturer of Promacta (eltrombopag olamine), generated $563 million in revenue, a 4% increase from the previous year, primarily driven by the treatment of severe aplastic anemia and chronic ITP in the United States[1].

Market Projections

The increasing demand for eltrombopag, driven by its use in cancer treatment, chronic hepatitis C, and severe aplastic anemia, is expected to continue driving the market growth. The projected growth to USD 5.28 billion by 2034 indicates a robust financial trajectory for eltrombopag choline and related products[1].

Key Players and Competition

Novartis

Novartis, with its Promacta brand, is a major player in the eltrombopag market. The company's revenue from Promacta has been steadily increasing, reflecting the drug's efficacy and market demand[1].

Teva Pharmaceuticals

Teva Pharmaceuticals has introduced Alvaiz, the choline salt form of eltrombopag, which offers an alternative to Promacta. This new formulation is expected to compete in the market, potentially expanding the overall market size[4][5].

Regulatory Environment

FDA Approvals

The FDA has approved eltrombopag choline tablets under the brand name Alvaiz, relying on the safety and efficacy findings of the listed drug Promacta. No additional clinical efficacy or safety data was required for this approval[4].

Safety and Efficacy

The FDA has ensured that the current labeling for eltrombopag choline is sufficient to provide adequate instructions for use, with no new safety information identified that was not already adequately labeled[4].

Challenges and Considerations

Adverse Effects

Eltrombopag, including its choline salt form, carries a black box warning due to potential severe adverse effects. These include interactions with other drugs and the risk of enhanced adverse effects or reduced efficacy of other medications[1].

Food Effects

The bioavailability of eltrombopag choline can be affected by food intake. For instance, administration after a high-fat, high-calorie meal can decrease the area under the curve (AUC) and maximum concentration (Cmax) significantly[2].

Healthcare Settings

Hospitals and Clinics

Hospitals and clinics are the primary settings for the use of eltrombopag choline, as these institutions have the necessary resources for interdisciplinary treatment and patient monitoring, especially for conditions like acute myeloid leukemia and chronic liver disease[1].

Key Takeaways

• The global eltrombopag drugs market is projected to grow significantly, reaching USD 5.28 billion by 2034.
• Eltrombopag choline is used for chronic immune thrombocytopenia, chronic hepatitis C, and severe aplastic anemia.
• North America and the Asia Pacific are key regions driving market growth.
• Oral administration is the preferred method due to its ease of use and high bioavailability.
• The market is competitive, with major players like Novartis and Teva Pharmaceuticals.
• Regulatory approvals and safety considerations are crucial for the drug's use.

FAQs

Q: What is the primary use of eltrombopag choline?

A: Eltrombopag choline is primarily used to treat thrombocytopenia in patients with chronic immune thrombocytopenia (ITP), chronic hepatitis C, and severe aplastic anemia.

Q: Which regions are driving the growth of the eltrombopag market?

A: North America and the Asia Pacific are the key regions driving the growth of the eltrombopag market.

Q: What is the projected market size for eltrombopag by 2034?

A: The global eltrombopag drugs market is projected to reach USD 5.28 billion by 2034.

Q: What are the potential adverse effects of eltrombopag choline?

A: Eltrombopag choline carries a black box warning due to potential severe adverse effects, including interactions with other drugs and enhanced adverse effects.

Q: How does food intake affect the bioavailability of eltrombopag choline?

A: Administration of eltrombopag choline after a high-fat, high-calorie meal can decrease its bioavailability by reducing the area under the curve (AUC) and maximum concentration (Cmax).

Sources

1. Towards Healthcare: Eltrombopag Drugs Market Size, Demand and Growth by 2034
2. FDA: Clinical Pharmacology Review: ALVAIZ (Eltrombopag Choline)
3. ResearchGate: Biochemical and Molecular Pharmacology in Drug Discovery
4. FDA: Clinical Review of 505(b)(2) Application: Eltrombopag Choline (Alvaiz)
5. Cigna: Eltrombopag Products Preferred Specialty Management Policy