KYTRIL Drug Patent Profile

When do Kytril patents expire, and what generic alternatives are available?

Kytril is a drug marketed by Roche and is included in three NDAs.

The generic ingredient in KYTRIL is granisetron hydrochloride. There are twenty-six drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the granisetron hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Kytril

A generic version of KYTRIL was approved as granisetron hydrochloride by AMNEAL on December 31^st, 2007.

Summary for KYTRIL

US Patents:	0
Applicants:	1
NDAs:	3
Raw Ingredient (Bulk) Api Vendors:	116
Clinical Trials:	20
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for KYTRIL
DailyMed Link:	KYTRIL at DailyMed

Recent Clinical Trials for KYTRIL

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

Sponsor	Phase
The University of The West Indies	Early Phase 1
Rutgers University	N/A
National Institute of General Medical Sciences (NIGMS)	N/A

See all KYTRIL clinical trials

Paragraph IV (Patent) Challenges for KYTRIL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
KYTRIL	Injection	granisetron hydrochloride	0.1 mg/mL, 1 mL single dose vial	020239	1	2007-03-08
KYTRIL	Injection	granisetron hydrochloride	1 mg/mL, 4 mL multi-dose vials	020239	1	2004-07-19
KYTRIL	Injection	granisetron hydrochloride	1 mg/mL, 1 mL vials	020239	1	2004-06-01

US Patents and Regulatory Information for KYTRIL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Roche	KYTRIL	granisetron hydrochloride	INJECTABLE;INJECTION	020239-003	Sep 17, 2004		DISCN	Yes	No
Roche	KYTRIL	granisetron hydrochloride	TABLET;ORAL	020305-002	Jun 15, 1998		DISCN	Yes	No
Roche	KYTRIL	granisetron hydrochloride	INJECTABLE;INJECTION	020239-002	Mar 11, 1994		DISCN	Yes	No

Expired US Patents for KYTRIL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Roche	KYTRIL	granisetron hydrochloride	INJECTABLE;INJECTION	020239-001	Dec 29, 1993	6,294,548
Roche	KYTRIL	granisetron hydrochloride	TABLET;ORAL	020305-001	Mar 16, 1995	4,886,808
Roche	KYTRIL	granisetron hydrochloride	INJECTABLE;INJECTION	020239-003	Sep 17, 2004	4,886,808

International Patents for KYTRIL

See the table below for patents covering KYTRIL around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	676032
Czechoslovakia	9103323
South Africa	8902737

Market Dynamics and Financial Trajectory for KYTRIL (Granisetron)

Last updated: July 31, 2025

Introduction

KYTRIL (generic name: granisetron) is a selective 5-HT3 receptor antagonist primarily prescribed to prevent nausea and vomiting associated with chemotherapy, radiation therapy, and post-operative settings. As a pivotal agent within the antiemetic landscape, KYTRIL has established a substantial market presence driven by clinical efficacy and expanded indications. This analysis examines the current market dynamics and forecasts the financial trajectory of KYTRIL, considering competitive, regulatory, and technological factors shaping its future.

Market Overview

The global antiemetic market, estimated at over $1.8 billion in 2022, continues to grow at a compound annual growth rate (CAGR) of approximately 4%, reflecting increasing cancer prevalence and advancements in supportive care. Granisetron, as a first-generation 5-HT3 antagonist, maintains a significant share owing to its proven safety profile and affordability. Its classification as a generic drug further influences market dynamics, impacting both pricing strategies and competitive positioning.

Key Market Drivers

Increasing Cancer Incidence

The rising incidence of various cancers, including breast, lung, and colorectal cancers, directly correlates with increased utilization of antiemetics such as KYTRIL. According to the World Health Organization, cancer cases are projected to reach 28.4 million worldwide by 2040, expanding the therapeutic need for effective nausea management in oncology.

Advancements in Oncology Supportive Care

Enhanced chemotherapy regimens with higher emetogenic potential necessitate robust antiemetic protocols. Granisetron's efficacy in reducing acute and delayed nausea affirms its role, ensuring continued demand. The development of extended-release formulations and combination therapies also supports improved adherence and outcomes.

Regulatory Approvals and Label Expansions

While initially approved for chemotherapy-induced nausea and vomiting (CINV), ongoing clinical studies exploring granisetron’s efficacy in other indications (e.g., radiation-induced nausea) could foster market expansion. Moreover, regulatory bodies such as the FDA and EMA's approval of generic versions catalyze accessibility and wider use.

Competitive Landscape

The antiemetic market features several agents, notably ondansetron and palonosetron, with varying efficacy profiles. The introduction of newer, longer-acting drugs such as netupitant-palonosetron combinations offers alternatives, but KYTRIL’s established safety and cost advantages preserve its relevance, especially in resource-constrained settings.

Market Challenges

Emergence of Newer Agents

Second- and third-generation 5-HT3 antagonists, particularly palonosetron with its longer half-life and improved efficacy, challenge KYTRIL’s market share. Additionally, NK1 receptor antagonists now often form part of combination regimens, reducing reliance on first-generation agents.

Patent and Pricing Dynamics

As a generic drug, KYTRIL’s pricing pressure intensifies, particularly in markets with high generic penetration. Market commoditization constrains revenue growth, urging manufacturers to innovate or expand indications.

Regulatory and Intellectual Property Trends

Patent expirations have proliferated, leading to increased generic competition. Moreover, coding and reimbursement policies influence prescribing behaviors and market penetration.

Financial Trajectory Analysis

Current Revenue and Market Share

KYTRIL’s revenue peaked during the early 2000s with brand dominance but has since stabilized due to growing generic competition. Leading manufacturers report declining sales, with estimates suggesting a 3-5% annual decrease in revenues from flagship formulations across mature markets.

Forecasting Future Market Potential

Despite declining proprietary revenues, the global demand for antiemetics remains robust, with emerging markets offering substantial growth opportunities due to expanding healthcare infrastructure and increased cancer awareness.

• Growth in Developing Markets: Countries such as India, China, and Brazil show rising adoption of generic antiemetics, potentially offsetting stagnation in developed markets.
• Innovative Formulations: Development of transdermal patches and extended-release formulations could revitalize sales channels, especially for hospital and outpatient settings.
• Indication Expansion: Clinical trials exploring KYTRIL’s role in managing nausea in non-oncological conditions (e.g., post-surgical nausea) could present new revenue streams.

Overall, the financial trajectory indicates a plateau in mature markets but potential growth driven by generics, new formulations, and expanding indications in emerging regions.

Regulatory Landscape and Implications

Regulatory policies favor the proliferation of generics, which suppress pricing but expand access. Ensuring compliance with evolving standards around bioequivalence and manufacturing quality remains crucial. Future approvals for novel delivery systems or combination therapies could influence market dynamics positively.

Strategic Outlook

Manufacturers seeking competitive advantage should focus on:

• Innovation: Developing novel formulations or delivery methods to differentiate KYTRIL.
• Geographic Expansion: Strengthening presence in emerging markets.
• Partnerships: Collaborating with oncology centers and healthcare providers to integrate KYTRIL into comprehensive supportive care regimens.
• Indication Diversification: Exploring off-label or new indications via clinical trials.

Key Takeaways

• The KYTRIL market faces steady erosion in branded revenues due to generic competition but remains vital due to its cost-effectiveness and proven efficacy.
• Expanding cancer incidence and supportive care protocols will sustain global demand, particularly in emerging markets.
• The competitive landscape is increasingly dominated by newer agents and combination therapies; KYTRIL’s future hinges on innovation and differentiation.
• Developing alternative formulations and exploring new clinical indications can unlock additional revenue streams.
• Regulatory trends favor increased accessibility of generics, although price competition constrains profit margins.

Conclusion

KYTRIL’s market volume and financial contributions are anticipated to decline modestly in mature regions but continue to hold strategic value in global antiemetic therapy frameworks. Lifecycle management—through innovation, geographic expansion, and indication diversification—remains essential for manufacturers aiming to sustain profitability amid ongoing competitive pressures.

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FAQs

1. What are the primary factors impacting KYTRIL’s market share?
   The rise of newer 5-HT3 antagonists like palonosetron, introduction of combination antiemetic therapies, patent expirations, and market saturation in developed countries have consistently eroded KYTRIL’s market share.

2. Are there new formulations of KYTRIL that could influence its market trajectory?
   Yes. Extended-release and transdermal formulations are under development and could improve patient adherence, opening new avenues for growth in hospital and outpatient settings.

3. How do regulatory changes affect KYTRIL’s commercial prospects?
   Increased approval of generic versions facilitates access but intensifies pricing competition. Conversely, regulatory support for new indications or delivery methods could provide growth opportunities.

4. What is the outlook for KYTRIL in emerging markets?
   High unmet medical needs and cost-sensitive healthcare systems favor generic antiemetics like KYTRIL, presenting significant growth potential despite competitive pressures.

5. What strategic moves should manufacturers consider to sustain KYTRIL's relevance?
   Investing in formulation innovation, geographic diversification, and exploring ancillary indications will be crucial to maintaining competitive advantage and revenue streams.

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References

1. Market Research Future. (2022). Antiemetics Market Size, Share, Trends, and Forecast.
2. World Health Organization. (2021). Global Cancer Statistics.
3. Grand View Research. (2023). Anti-Emetics Market Analysis and Forecast.
4. U.S. Food and Drug Administration. (2022). Guidance for Industry: Bioequivalence Recommendations.
5. pharmaceuticalindustry.com. (2023). Patent Expirations and Generic Competition Trends.