Granisetron hydrochloride - Generic Drug Details

What are the generic sources for granisetron hydrochloride and what is the scope of freedom to operate?

Granisetron hydrochloride is the generic ingredient in four branded drugs marketed by Am Regent, Amneal, Baxter Hlthcare Corp, Bionpharma, Dr Reddys, Epic Pharma Llc, Eugia Pharma, Fresenius Kabi Usa, Hikma, Hikma Farmaceutica, Mylan Asi, Pharmobedient, Rising, Sandoz, Sandoz Inc, Teva Pharms Usa, Wockhardt Usa, Yung Shin Pharm, Roche, Intra Sana Labs, Apotex Inc, Aurobindo Pharma Usa, Barr, Chartwell Molecular, Dr Reddys Labs Ltd, Natco Pharma, Orbion Pharms, Taro, and Teva Pharms, and is included in fifty-one NDAs. Additional information is available in the individual branded drug profile pages.

There are nineteen drug master file entries for granisetron hydrochloride. Eight suppliers are listed for this compound.

Summary for granisetron hydrochloride

US Patents:	0
Tradenames:	4
Applicants:	29
NDAs:	51
Drug Master File Entries:	19
Finished Product Suppliers / Packagers:	8
Raw Ingredient (Bulk) Api Vendors:	116
Clinical Trials:	137
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for granisetron hydrochloride
What excipients (inactive ingredients) are in granisetron hydrochloride?	granisetron hydrochloride excipients list
DailyMed Link:	granisetron hydrochloride at DailyMed

Recent Clinical Trials for granisetron hydrochloride

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

Sponsor	Phase
Meri Mirceta	PHASE4
Aiman Al-Touny	PHASE4
University of Malaya	PHASE4

See all granisetron hydrochloride clinical trials

Pharmacology for granisetron hydrochloride

Drug Class	Serotonin-3 Receptor Antagonist
Mechanism of Action	Serotonin 3 Receptor Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for granisetron hydrochloride

A04AA	Serotonin (5HT3) antagonists
A04A	ANTIEMETICS AND ANTINAUSEANTS
A04	ANTIEMETICS AND ANTINAUSEANTS
A	Alimentary tract and metabolism

Paragraph IV (Patent) Challenges for GRANISETRON HYDROCHLORIDE

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 granisetron hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Intra Sana Labs	GRANISETRON HYDROCHLORIDE	granisetron hydrochloride	SOLUTION;ORAL	219282-001	Mar 17, 2025		RX	No	No
Baxter Hlthcare Corp	GRANISETRON HYDROCHLORIDE	granisetron hydrochloride	INJECTABLE;INJECTION	078198-001	Jun 30, 2008		DISCN	No	No
Mylan Asi	GRANISETRON HYDROCHLORIDE	granisetron hydrochloride	INJECTABLE;INJECTION	091136-001	Apr 9, 2010	AP	RX	No	No

Expired US Patents for granisetron hydrochloride

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

Market Dynamics and Financial Trajectory for Granisetron Hydrochloride

Last updated: July 27, 2025

Introduction

Granisetron hydrochloride is a selective serotonin 3 (5-HT3) receptor antagonist utilized primarily as an antiemetic agent to prevent nausea and vomiting caused by chemotherapy, radiation therapy, and postoperative conditions. Since its initial approval, it has become a critical component in supportive cancer care. Analyzing the market dynamics and projecting its financial trajectory involves understanding current demand drivers, competitive landscape, regulatory environment, technological advances, and future growth prospects.

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Market Overview

The global antiemetic drugs market, valued at approximately $2.4 billion in 2022, is poised for steady growth, with granisetron hydrochloride constituting a substantial share due to its proven efficacy and safety profile. Its popularity stems from its targeted mechanism of action and reduced adverse event profile compared to older medications like dopamine antagonists.

The market's expansion is driven by increasing cancer incidence globally, advancements in chemotherapy protocols, and heightened awareness of supportive care in oncology. Moreover, the expanding geriatric population prone to various malignancies further sustains demand for antiemetic agents, including granisetron.

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Market Drivers

1. Rising Cancer Incidence

The global cancer burden is estimated to reach 28.4 million new cases annually by 2040, according to the WHO. Chemotherapy remains a cornerstone of cancer treatment, and the associated risk of chemotherapy-induced nausea and vomiting (CINV) necessitates effective antiemetics like granisetron hydrochloride. This link directly correlates rising cancer cases with increased demand.

2. Technological and Formulation Advances

Development of sustained-release formulations, transdermal patches, and intravenous (IV) options enhances patient compliance and broadens therapeutic applications. Companies investing in novel delivery systems position themselves favorably, extending market lifespan.

3. Increasing Adoption in Supportive Care

Oncology centers and hospitals globally are integrating antiemetics into standard protocols. The inclusion of granisetron in clinical guidelines, such as those by ASCO and NCCN, cements its critical role and sustains demand.

4. Regulatory Approvals and Patent Landscape

While generic versions have eroded original patent protections, recent regulatory approvals of innovative formulations maintain market relevance. Regulatory efforts encourage product diversification, boosting sales.

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Market Challenges and Restraints

1. Competition from Alternative Agents

Other 5-HT3 antagonists like ondansetron and palonosetron have competing efficacy profiles. The emergence of NK1 receptor antagonists and multimodal antiemetic regimens may also erode granisetron’s market share in certain settings.

2. Patent Expiry and Generic Competition

Patent expirations have led to a surge in generics, significantly reducing prices and impacting revenues of branded formulations. Manufacturers need to innovate through new formulations to sustain profitability.

3. Side Effect Profile and Safety Concerns

While generally well-tolerated, rare adverse effects, such as QT prolongation, necessitate cautious use. Such concerns influence prescriber preferences, especially in vulnerable populations.

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Regulatory and Geographic Landscape

The approval landscape remains robust, with granisetron formulations approved across North America, Europe, and Asia-Pacific. Notably, India and China witness rapid growth owing to expanding healthcare infrastructure and cost-sensitive markets favoring generics.

Regulatory bodies, like the FDA and EMA, continuously update guidelines to incorporate new evidence and formulations, influencing market strategies.

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Financial Trajectory and Future Outlook

1. Market Growth Projections

Forecasts estimate a compound annual growth rate (CAGR) of approximately 4-6% from 2023 to 2030. This is driven by increasing cancer prevalence and expanding indications, such as prophylaxis in pediatric oncology.

2. Revenue Streams

Branded products still command premium pricing in developed markets, but revenue contributions increasingly shift toward generics, especially in cost-conscious regions. Market segmentation shows hospital procurement as the dominant channel, with outpatient and specialty clinics gaining prominence.

3. Strategic Market Expansion

Biotech companies and pharma giants are investing in formulations like subcutaneous injections and patch technology, promising higher margins. Partnerships with biotech firms for innovative delivery systems could generate new revenue streams.

4. Impact of Biosimilars and Market Entry Barriers

As biosimilars and generic versions proliferate, prices are expected to decline, compressing profit margins but broadening access, which sustains overall volume growth.

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Conclusion

The market for granisetron hydrochloride is robust and poised for steady growth, driven primarily by expanding cancer incidence, innovations in drug delivery, and supportive clinical guidelines. However, intensifying competition, patent expirations, and evolving regulatory landscapes pose challenges. Future success will depend on how manufacturers innovate to differentiate their offerings, expand geographic reach, and optimize formulations for patient compliance.

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Key Takeaways

• Demand Drivers: Rising global cancer burden, improved supportive care protocols, and technological advancements bolster granisetron's market position.
• Competitive Landscape: Dominated by generic producers post-patent expiry; innovation in formulations is critical to maintaining margins.
• Regulatory Factors: Regular updates and approvals across regions influence market expansion and product lifecycle.
• Financial Outlook: CAGR projected at 4-6% through 2030, with revenue growth sustained by volume increases and new formulations.
• Strategic Focus: Diversification into innovative delivery methods and geographic expansion remains essential for long-term profitability.

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FAQs

1. What are the primary indications for granisetron hydrochloride?
Granisetron is primarily indicated for preventing chemotherapy-induced nausea and vomiting, radiation therapy-associated emesis, and postoperative nausea in medical settings.

2. How does granisetron differ from other 5-HT3 antagonists?
Granisetron offers a longer half-life compared to ondansetron, allowing for prolonged antiemetic effect, and is available in various formulations like transdermal patches and IV solutions, enhancing patient compliance.

3. What impact has generic competition had on the market?
Patent expirations have led to increased generic availability, reducing prices and profit margins for branded products, but also broadening access and volume sales.

4. Are there recent innovations in granisetron formulations?
Yes. Recent developments include sustained-release transdermal patches, subcutaneous injections, and combination therapies to improve efficacy and convenience.

5. What are the future opportunities for manufacturers of granisetron?
Opportunities lie in developing novel delivery systems, expanding into emerging markets, and integrating granisetron into multimodal supportive care regimens aligned with personalized oncology approaches.

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References

[1] MarketWatch, “Global Antiemetics Market Size & Share Analysis,” 2022.
[2] WHO, “Cancer Statistics,” 2022.
[3] NCCN Guidelines, “Antiemetic Supportive Care,” 2022.
[4] Allied Market Research, “Anti-Emetics Market Forecast,” 2023.
[5] FDA and EMA Regulatory Updates, 2022.