ALVAIZ Drug Patent Profile

Which patents cover Alvaiz, and when can generic versions of Alvaiz launch?

Alvaiz is a drug marketed by Teva Pharms Inc and is included in one NDA. There is one patent protecting this drug.

This drug has two patent family members in two countries.

The generic ingredient in ALVAIZ is eltrombopag choline. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the eltrombopag choline profile page.

DrugPatentWatch^® Generic Entry Outlook for Alvaiz

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be November 5, 2038. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for ALVAIZ

International Patents:	2
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Drug Prices:	Drug price information for ALVAIZ
What excipients (inactive ingredients) are in ALVAIZ?	ALVAIZ excipients list
DailyMed Link:	ALVAIZ at DailyMed

See drug prices for ALVAIZ

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

Constraining patent/regulatory exclusivity:

11,072,586

NDA:

216774

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 ALVAIZ

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

US Patents and Regulatory Information for ALVAIZ

ALVAIZ is protected by three US patents.

This potential generic entry date is based on patent 11,072,586.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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	216774-001	Nov 29, 2023		RX	Yes	No	11,072,586		Y	Y
Teva Pharms Inc	ALVAIZ	eltrombopag choline	TABLET;ORAL	216774-003	Nov 29, 2023		RX	Yes	No	11,072,586		Y	Y
Teva Pharms Inc	ALVAIZ	eltrombopag choline	TABLET;ORAL	216774-002	Nov 29, 2023		RX	Yes	No	11,072,586		Y	Y
Teva Pharms Inc	ALVAIZ	eltrombopag choline	TABLET;ORAL	216774-004	Nov 29, 2023		RX	Yes	Yes	11,072,586		Y	Y

International Patents for ALVAIZ

When does loss-of-exclusivity occur for ALVAIZ?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

European Patent Office

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 ALVAIZ around the world.

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 ALVAIZ

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
1534390	C20100006 00032	Estonia		PRODUCT NAME: REVOLADE-ELTROMBOPAG; REG NO/DATE: C(2010)1662 11.03.2010
1294378	C300451	Netherlands		PRODUCT NAME: ELTROMBOPAG, DESGEWENST IN DE; REGISTRATION NO/DATE: EU/1/10/612/001-006 20100311
1534390	PA2010007,C1534390	Lithuania		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

ALVAIZ Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ALVAIZ (Eltrombopag)

Introduction to ALVAIZ (Eltrombopag)

ALVAIZ, marketed under the brand name Promacta by Novartis, is a thrombopoietin receptor agonist used to treat thrombocytopenia, a condition characterized by low platelet counts in the blood. This medication is crucial in managing conditions such as chronic immune thrombocytopenia (ITP), severe aplastic anemia, and thrombocytopenia associated with chronic hepatitis C and certain types of cancer treatments.

Market Size and Growth

The global eltrombopag drugs market, which includes ALVAIZ, has been experiencing significant growth. As of 2023, the market size was estimated at USD 2.28 billion and is projected to reach USD 5.28 billion by 2034, growing at a compound annual growth rate (CAGR) of 7.94% from 2024 to 2034[1].

Key Drivers of Market Growth

Increasing Demand in Cancer Treatment

Thrombocytopenia is a common complication during cancer treatment, particularly in patients undergoing chemotherapy or those with acute myeloid leukemia (AML). The increasing incidence of cancer and the need for effective treatments that manage thrombocytopenia are driving the demand for eltrombopag[1].

Chronic Immune Thrombocytopenia (ITP)

Eltrombopag is used to treat chronic ITP, especially in patients who have not responded to other treatments such as immunoglobulin or steroids. The prevalence of ITP and the effectiveness of eltrombopag in managing this condition contribute to the market growth[1].

Chronic Hepatitis C

Eltrombopag is also used in conjunction with interferon therapy to treat thrombocytopenia in individuals with chronic hepatitis C. This additional use case expands the market reach of the drug[1].

Regional Market Dynamics

Asia Pacific

The Asia Pacific region is a significant growth area for the eltrombopag market due to increased foreign investment and collaborative efforts among market players. The large population and growing healthcare infrastructure in this region are key factors driving market expansion[1].

Market Segmentation

By Type

The tablets segment dominates the eltrombopag market due to the ease of administration, affordability, and high patient compliance rates associated with oral medications. The solubility of eltrombopag in water enhances its bioavailability, making oral administration the preferred method[1].

Financial Performance

Revenue and Sales

In 2023, Novartis generated $563 million in revenue from its eltrombopag medications, marking a 4% increase year-over-year. This growth is primarily attributed to the increasing usage in the United States for treating severe aplastic anemia and chronic ITP[1].

Competitive Landscape

The market for eltrombopag is competitive, with several pharmaceutical companies involved in research and development to improve therapies. Novartis, with its Promacta brand, is a leading player in this market. Other companies are also investing in R&D to establish a strong presence globally, particularly in the Asia Pacific region[1].

Dosage and Administration

The dosage of ALVAIZ is adjusted based on platelet count responses. For instance, if the platelet count is less than 50 x 10^9/L after at least two weeks of treatment, the daily dose may be increased by 18 mg to a maximum of 72 mg/day. Conversely, if the platelet count exceeds 400 x 10^9/L, treatment is stopped for one week and then reinitiated at a reduced dose[2][4].

Safety and Adverse Reactions

Eltrombopag can have significant adverse effects, including hepatotoxicity, thrombotic/thromboembolic complications, and increased risk of death and progression to AML in certain patient groups. Monitoring of liver tests and platelet counts is crucial to manage these risks[2].

Regulatory and Compliance Considerations

The use of eltrombopag is subject to stringent regulatory requirements. For example, patients with low albumin levels or high Model for End-Stage Liver Disease (MELD) scores are at greater risk for hepatic decompensation and require careful monitoring. Discontinuation of the drug may be necessary in cases of severe adverse reactions[2].

Future Outlook

The growing demand for eltrombopag, driven by its efficacy in treating thrombocytopenia across various conditions, is expected to continue. The market's expansion into the Asia Pacific region and the ongoing research and development efforts by pharmaceutical companies will further fuel growth.

Key Takeaways

• The global eltrombopag market is projected to grow from USD 2.28 billion in 2023 to USD 5.28 billion by 2034.
• Increasing demand in cancer treatment and chronic ITP are key drivers of market growth.
• The Asia Pacific region is a significant growth area due to its large population and growing healthcare infrastructure.
• Oral administration of eltrombopag dominates the market due to its ease of use and high bioavailability.
• Novartis's Promacta brand is a leading player in the market, with significant revenue generated in 2023.
• The drug has potential adverse effects, including hepatotoxicity and thrombotic complications, requiring careful monitoring.

FAQs

Q: What is ALVAIZ (eltrombopag) used for? A: ALVAIZ is used to treat thrombocytopenia in adult and pediatric patients, including conditions such as chronic immune thrombocytopenia (ITP), severe aplastic anemia, and thrombocytopenia associated with chronic hepatitis C and certain cancer treatments.

Q: What is the projected market size for eltrombopag by 2034? A: The global eltrombopag market is projected to reach USD 5.28 billion by 2034, growing at a CAGR of 7.94% from 2024 to 2034.

Q: Why is the Asia Pacific region significant for the eltrombopag market? A: The Asia Pacific region is significant due to its large population, growing healthcare infrastructure, and increased foreign investment and collaborative efforts among market players.

Q: What are the potential adverse effects of ALVAIZ? A: Potential adverse effects include hepatotoxicity, thrombotic/thromboembolic complications, and increased risk of death and progression to AML in certain patient groups.

Q: How is the dosage of ALVAIZ adjusted? A: The dosage of ALVAIZ is adjusted based on platelet count responses, with increases or decreases in dose depending on the platelet count levels to achieve and maintain target platelet counts.

Sources:

1. Towards Healthcare, "Eltrombopag Drugs Market Size, Demand and Growth by 2034"
2. FDA, "ALVAIZ™ (eltrombopag) - Label"
3. Alvarez & Marsal, "The Pharmacovigilance M&A Market"
4. RxList, "Alvaiz (Eltrombopag Tablets): Side Effects, Uses, Dosage"