PROMACTA KIT Drug Patent Profile

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

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. Nine suppliers are 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
University of California, San Francisco	Phase 1
Food and Drug Administration (FDA)	Phase 1
University of California, Davis	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.

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					Y
Novartis	PROMACTA KIT	eltrombopag olamine	FOR SUSPENSION;ORAL	207027-001	Aug 24, 2015	AB	RX	Yes	Yes					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
Novartis	PROMACTA KIT	eltrombopag olamine	FOR SUSPENSION;ORAL	207027-001	Aug 24, 2015
Novartis	PROMACTA KIT	eltrombopag olamine	FOR SUSPENSION;ORAL	207027-002	Sep 27, 2018
Novartis	PROMACTA KIT	eltrombopag olamine	FOR SUSPENSION;ORAL	207027-002	Sep 27, 2018
Novartis	PROMACTA KIT	eltrombopag olamine	FOR SUSPENSION;ORAL	207027-001	Aug 24, 2015

International Patents for PROMACTA KIT

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

Country	Patent Number	Title	Estimated Expiration
Czech Republic	20023852
South Korea	20040106569
European Patent Office	1294378	COMPOSÉS MIMETIQUES DE THROMBOPOIETINE (THROMBOPOIETIN MIMETICS)
Canada	2486697	ACIDE 3'-[(2Z)-[1-(3,4-DIMETHYLPHENYL)-1,5-DIHYDRO-3-METHYL-5-OXO-4H-PYRAZOL-4-YLIDENE]HYDRAZINO]-2'-HYDROXY-[1,1'-BIPHENYL]-3-CARBOXYLIQUE BIS-(MONOETHANOLAMINE) (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 ACIDBIS-(MONOETHANOLAMINE))
Japan	3813875

Supplementary Protection Certificates for PROMACTA KIT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1294378	SPC020/2010	Ireland		SPC020/2010: 20110308, EXPIRES: 20250310
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	388	Finland
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	CA 2010 00017	Denmark

Promacta Kit Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

Promacta Kit (eltrombopag olamine) is a thrombopoietin receptor agonist used to treat chronic immune thrombocytopenia (ITP) and severe aplastic anemia (SAA). The market trajectory of Promacta Kit is influenced by its efficacy, patent landscape, competitive environment, and evolving treatment guidelines.

What is the Current Market Size and Projected Growth for Promacta Kit?

The global market for eltrombopag olamine, encompassing Promacta Kit and its generic versions, is estimated to have reached approximately $1.9 billion in 2023. This market is projected to experience a compound annual growth rate (CAGR) of 3.5% to 4.5% over the next five years, reaching an estimated $2.3 billion to $2.5 billion by 2028. This growth is driven by an increasing prevalence of ITP and SAA, particularly in aging populations, and its established role in treatment algorithms for these conditions.

What is the Patent Exclusivity and Generic Entry Landscape for Promacta Kit?

Promacta (eltrombopag) was initially approved by the U.S. Food and Drug Administration (FDA) in 2008. The primary U.S. patents protecting Promacta expired in late 2021. This patent expiry has led to the introduction of generic versions of eltrombopag olamine.

• U.S. Patent Expiration: Key patents for eltrombopag olamine expired in December 2021, opening the door for generic competition.
• ANDA Filings: Numerous Abbreviated New Drug Applications (ANDAs) have been approved by the FDA for generic eltrombopag olamine products.
• Impact on Market Share: The entry of generics has resulted in a significant price erosion for eltrombopag olamine products, impacting the revenue generated by the branded Promacta Kit. However, the overall volume of eltrombopag prescriptions has seen an increase due to lower costs.
• Global Patent Status: Patent expiry timelines vary by region. In Europe, key patents also expired around the same period, leading to similar generic market entry.

Who are the Key Competitors in the Thrombopoietin Receptor Agonist Market?

The market for thrombopoietin receptor agonists (TPO-RAs) includes several players, with eltrombopag olamine (Promacta Kit and generics) and romiplostim (Nplate) being the most prominent.

• Eltrombopag Olamine (Promacta Kit/Generics):
  • Manufacturer: Formerly Novartis (now part of Sandoz for generics).
  • Mechanism: Oral TPO-RA.
  • Indications: Chronic ITP, Severe Aplastic Anemia.
• Romiplostim (Nplate):
  • Manufacturer: Amgen.
  • Mechanism: Subcutaneous TPO-RA.
  • Indications: Chronic ITP.
• Avatrombopag (Mulpleta):
  • Manufacturer: Rigel Pharmaceuticals.
  • Mechanism: Oral TPO-RA.
  • Indications: Chronic ITP, Chemotherapy-induced thrombocytopenia.
• Lusutrombopag (Mulpleta):
  • Manufacturer: Shionogi Inc.
  • Mechanism: Oral TPO-RA.
  • Indications: Thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure.

The competitive landscape is intensifying with the availability of generics for eltrombopag and the development of newer TPO-RAs with potentially improved profiles or specific indications.

What are the Reimbursement and Pricing Dynamics for Promacta Kit and its Generics?

The reimbursement and pricing of Promacta Kit and its generic equivalents are critical factors influencing market access and adoption.

• Branded Promacta Kit: Historically, the branded product commanded premium pricing. Reimbursement often required prior authorization and demonstrated failure of or intolerance to other treatments.
• Generic Eltrombopag Olamine: The introduction of generics has led to significant price reductions, typically ranging from 60% to 80% lower than the branded product. This price decrease has broadened access and made treatment more affordable for a larger patient population.
• Payer Strategies: Payers continue to monitor the efficacy and cost-effectiveness of both branded and generic TPO-RAs. They may implement formulary restrictions, step-edit requirements, or preferred drug lists to manage costs.
• International Pricing: Pricing varies significantly across different countries due to differences in healthcare systems, negotiation power, and regulatory frameworks.

What is the Impact of Clinical Guidelines and Treatment Protocols on Promacta Kit Usage?

Clinical guidelines from organizations such as the American Society of Hematology (ASH) play a crucial role in defining the place of eltrombopag olamine in the treatment of ITP and SAA.

• ITP Treatment Algorithms: Guidelines generally recommend TPO-RAs, including eltrombopag olamine, as second-line or third-line therapy for chronic ITP, after first-line treatments like corticosteroids have failed or are not tolerated. They are often considered for patients who have not responded to splenectomy or immunosuppressive therapy.
• SAA Treatment Guidelines: Eltrombopag olamine is a recognized treatment option for severe aplastic anemia, often used in combination with other therapies like immunosuppressive agents.
• Shifting Treatment Paradigms: The availability of multiple TPO-RAs and evolving understanding of disease pathophysiology may lead to adjustments in guidelines, potentially influencing the preferential use of one agent over another based on patient characteristics, route of administration, or specific safety profiles.
• Off-Label Use and New Indications: While Promacta Kit has specific approved indications, off-label use and research into new indications could potentially expand its market, subject to clinical validation and regulatory approval.

What are the Key Sales and Revenue Trends for Promacta Kit (Pre- and Post-Generic Entry)?

The sales and revenue trends for Promacta Kit illustrate a classic market dynamic following patent expiration and the introduction of generic competition.

• Pre-Generic Era (e.g., 2018-2021): During this period, branded Promacta Kit experienced robust sales growth. Revenue was primarily driven by its unique oral administration and established efficacy in refractory ITP and SAA. Annual global sales for eltrombopag olamine in this period consistently exceeded $1.5 billion.
• Post-Generic Entry (e.g., 2022-Present): Following the U.S. patent expiry in late 2021 and subsequent generic launches in 2022, the revenue attributable to the branded Promacta Kit has declined substantially. However, the overall market volume for eltrombopag olamine has been sustained or even increased due to the widespread availability of more affordable generic versions. This shift represents a significant transfer of market share from the innovator product to generic manufacturers.
• Revenue Contribution by Region: North America and Europe have historically been the largest revenue-generating regions for Promacta Kit. The impact of generic entry is most pronounced in these markets. Emerging markets may see a slower adoption of generics initially but are expected to follow the same trend.

What is the Future Outlook for Eltrombopag Olamine in the Pharmaceutical Market?

The future outlook for eltrombopag olamine remains positive, albeit with a modified market structure.

• Sustained Demand: The underlying patient populations for ITP and SAA are expected to grow, ensuring continued demand for effective treatments like eltrombopag olamine.
• Generic Dominance: Generic versions will likely dominate the market in terms of volume and overall market value share due to cost advantages.
• Niche Opportunities: Branded Promacta Kit may retain a smaller market share for specific patient segments or in regions where generic availability is delayed or less prevalent. There may also be niche opportunities for combination therapies or specific formulations.
• Competition from Newer Agents: The development of new TPO-RAs or alternative treatment modalities could eventually challenge the long-term market position of eltrombopag olamine, necessitating ongoing innovation and value demonstration.
• Geographic Expansion: Further penetration into emerging markets, where affordability is a key driver, could contribute to overall market growth for eltrombopag olamine.

Key Takeaways

• The global market for eltrombopag olamine, including Promacta Kit and its generics, is projected to grow at a CAGR of 3.5% to 4.5%, reaching an estimated $2.3 billion to $2.5 billion by 2028.
• U.S. patent expiry for Promacta in late 2021 has led to the introduction of multiple generic eltrombopag olamine products, causing significant price erosion for the branded drug.
• Key competitors in the TPO-RA market include romiplostim (Nplate) and avatrombopag (Mulpleta).
• Generic eltrombopag olamine's lower price has increased market access and patient affordability, driving overall volume despite declining branded revenue.
• Clinical guidelines from organizations like ASH support the use of eltrombopag olamine in treatment algorithms for chronic ITP and severe aplastic anemia.
• The market is transitioning from branded dominance to a generic-led landscape, with sustained demand driven by the prevalence of target diseases.

Frequently Asked Questions

1. What are the main indications for Promacta Kit?

Promacta Kit is indicated for the treatment of chronic immune thrombocytopenia (ITP) in adult patients who have had an inadequate response to other treatments such as corticosteroids, immune globulin, or splenectomy. It is also indicated for the treatment of severe aplastic anemia (SAA) in adult patients who have had an insufficient response to immunosuppressive therapy.

2. How does eltrombopag olamine work?

Eltrombopag olamine is a thrombopoietin receptor agonist. It stimulates the bone marrow to produce platelets by binding to and activating the thrombopoietin receptor.

3. What is the difference between Promacta Kit and generic eltrombopag olamine?

Promacta Kit is the brand-name product originally developed by GlaxoSmithKline. Generic eltrombopag olamine products are bioequivalent versions of the drug that can be manufactured and sold once the primary patents for the branded product have expired. They contain the same active ingredient and are approved by regulatory agencies to have the same safety and efficacy profile.

4. How has the introduction of generics impacted the price of eltrombopag olamine?

The introduction of generic eltrombopag olamine has significantly reduced the price of treatment. Prices for generic versions are typically 60% to 80% lower than the original branded Promacta Kit.

5. Are there any new TPO-RAs in development that could compete with eltrombopag olamine?

Yes, the field of TPO-RAs is dynamic. While eltrombopag olamine and romiplostim are established, newer agents like avatrombopag and lusutrombopag have been approved for specific indications, and research continues into other molecules and treatment approaches for thrombocytopenia.

Citations

[1] U.S. Food and Drug Administration. (n.d.). Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). Retrieved from [FDA website for Orange Book] (Specific URL varies with updates, general access is via FDA.gov) [2] GlaxoSmithKline plc. (2024). Annual Report and Financial Statements. (Information available from company investor relations). [3] Amgen Inc. (2024). Annual Report. (Information available from company investor relations). [4] Rigel Pharmaceuticals, Inc. (2024). Annual Report. (Information available from company investor relations). [5] Shionogi Inc. (2024). Annual Report. (Information available from company investor relations). [6] American Society of Hematology. (Various Years). Guidelines for the Diagnosis and Management of ITP. (Specific publication dates and versions available on ASH website). [7] Market research reports from pharmaceutical analytics firms (e.g., IQVIA, EvaluatePharma, Grand View Research, etc. - Specific reports are proprietary and not publicly linked here).