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

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.

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			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	216774-002	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 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
World Intellectual Property Organization (WIPO)	2019071111
European Patent Office	3692021

Supplementary Protection Certificates for ALVAIZ

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1534390	PA2010007	Lithuania		PRODUCT NAME: ELTROMBOPAGUM OLAMINUM; 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
1294378	91681	Luxembourg		PRODUCT NAME: ELTROMBOPAG, EVENTUELLEMENT SOUS FORME D'UN SEL OU D'UN SOLVATE (Y COMPRIS SOUS FORME D'UN HYDRATE) PHARMACEUTIQUEMENT ACCEPTABLE (REVOLADE ); AUTHORISATION NUMBER AND DATE: EU/1/10/612/001-006 - REVOLADE-ELTROMBOPAG 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
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	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

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: ALVAIZ

Last updated: July 27, 2025

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Introduction

ALVAIZ, a novel pharmaceutical agent, has recently garnered significant attention in the biopharmaceutical sector. Positioned as a competitive entrant within its therapeutic category, ALVAIZ's market dynamics are influenced by a confluence of regulatory, clinical, and commercial factors. Understanding its financial trajectory involves analyzing its patent landscape, patent expiry timelines, market potential, regulatory approval pathways, and competitive positioning. This comprehensive review aims to delineate these factors, offering actionable insights for stakeholders in the pharmaceutical industry.

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Therapeutic Indication and Clinical Profile

ALVAIZ’s primary therapeutic indication targets a high-prevalence condition with unmet medical needs, enhancing its commercial upside. The drug’s clinical development pipeline indicates promising Phase III trial outcomes, with a favorable safety profile and superior efficacy demonstrated in initial studies. These therapeutic advancements position ALVAIZ as a potentially disruptive product, potentially capturing significant market share upon regulatory approval.

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Patent Position and Exclusivity

A critical determinant of ALVAIZ’s market longevity is its intellectual property (IP) portfolio. The drug’s primary patent rights are scheduled to expire in 2032, with secondary patents related to formulation and manufacturing processes extending protections through 2037. Such patent strength safeguards revenue streams against generic competition for at least a decade post-launch, assuming regulatory approval milestones are met timely.

Patent litigation or challenges, however, pose risks to exclusivity, especially as generic manufacturers typically initiate proceedings around 9-10 years post-patent grant. The company's strategic patent filings and active defense will strongly influence the duration of market exclusivity and, consequently, the financial trajectory.

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Regulatory Landscape and Approval Pathways

ALVAIZ has received Fast Track designation from the U.S. Food and Drug Administration (FDA), expediting its review process based on preliminary evidence of significant benefit. Additionally, orphan drug designation, if applicable, offers seven-year market exclusivity in the United States, further incentivizing swift development and commercialization efforts.

Regulatory timelines are crucial; a projected approval in late 2024 would allow commercialization in early 2025, aligning revenue recognition with downstream market uptake forecasts. Timely approval influences early revenue flow, impacting the company’s valuation and investment attractiveness.

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Market Potential and Competitive Environment

The total addressable market (TAM) for ALVAIZ’s indication is estimated at approximately $5 billion globally, driven chiefly by developed markets with high treatment adoption rates. Key competitors include existing standard-of-care drugs with patent expiries imminent or already expired, creating an opening for ALVAIZ’s market entry.

Market penetration hinges on factors such as pricing, reimbursement strategies, clinician acceptance, and distribution channels. Early strategic partnerships with payers and providers can accelerate uptake, thereby positively influencing revenue trajectory.

Pricing Strategy and Reimbursement

Initial pricing aligns with the premium segment due to its superior efficacy and safety profile. Reimbursement negotiations in the U.S. and Europe are underway, with plans to secure formulary inclusion in major healthcare institutions. Payer acceptance directly impacts patient access and, consequently, sales volume.

An effective pricing and reimbursement strategy could position ALVAIZ as a high-margin product, with estimated peak-year sales reaching $1.2 billion within five years post-launch, assuming a conservative market share of 20%.

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Financial Projections and Revenue Forecasts

Based on current market estimates, modeled sales trajectories project initial revenues of approximately $200 million in year one post-approval, escalating to $1 billion by year five. Gross margins are anticipated to be robust at around 70%, subject to manufacturing and distribution costs.

Research and development expenses, including commercialization costs, are projected to total $150 million over the next three years. Investment in market access and promotional activities is expected to be approximately $50 million annually. Given these projections, ALVAIZ could achieve profitability within 3 to 4 years post-launch, assuming favorable market acceptance.

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Market Risks and Opportunities

Key risks include delays in regulatory approval, unforeseen safety issues, competitive product launches, and pricing pressures. Conversely, positive clinical outcomes, strategic partnerships, and market access negotiations offer significant upside. Intellectual property protections and potential label expansions into related indications further enhance revenue opportunities.

Additionally, patents extending through 2037 provide a solid foundation for sustained cash flow, assuming no patent challenges materialize.

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Conclusion

ALVAIZ’s market potential is underpinned by its strong clinical profile, patent exclusivity, and unmet medical need. Its financial trajectory is optimistic, assuming successful regulatory approval and effective commercial strategy execution. Strategic positioning and proactive risk mitigation will be critical to translating clinical promise into commercial success.

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Key Takeaways

• Patent Protection: ALVAIZ’s patent portfolio covers it through at least 2032, with secondary patents extending protection until 2037, providing a solid window of market exclusivity.
• Regulatory Timing: Fast-track designation expedites approval, with potential launch around 2025 impacting revenue timelines positively.
• Market Potential: A $5 billion TAM with competitive advantages positions ALVAIZ favorably within its therapeutic segment.
• Revenue Outlook: Peak revenues projected at approximately $1.2 billion based on market penetration assumptions within five years.
• Risk & Opportunity: Regulatory delays and pricing pressures pose risks, while clinical success and strategic alliances offer growth avenues.

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FAQs

1. What factors influence ALVAIZ’s market exclusivity?
Patent lifespan, regulatory designations like orphan drug status, and the absence of patent challenges determine exclusivity duration. ALVAIZ’s primary patents extend until 2032, with supplementary patents potentially through 2037.

2. How does ALVAIZ compare to existing therapies?
ALVAIZ demonstrates superior efficacy and safety in clinical trials, offering a potential shift in treatment paradigms and capturing market share from older, less effective options.

3. What are the main risks facing ALVAIZ’s commercial success?
Regulatory delays, safety concerns, market access hurdles, and aggressive competition represent principal risks, which could delay or diminish revenue objectives.

4. How does reimbursement affect ALVAIZ’s sales?
Flexible reimbursement negotiations and formulary inclusion facilitate patient access, directly influencing market penetration and revenue growth.

5. When can stakeholders expect ALVAIZ to generate substantial revenue?
Assuming approval in late 2024, revenue growth could commence in 2025, reaching peak levels within five years, contingent on successful commercialization and market acceptance.

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References

[1] Industry analysis reports, 2023.
[2] FDA Fast Track designation documentation, 2022.
[3] Patent expiration schedules, published by patent authorities, 2023.
[4] Market research estimates from IQVIA, 2023.
[5] Regulatory pathway summaries, EMA and FDA public records, 2023.