Granisetron - Generic Drug Details

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

Granisetron is the generic ingredient in six branded drugs marketed by Cumberland, Heron Theraps Inc, 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-three NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Granisetron has forty patent family members in thirty-one countries.

There are twenty-six drug master file entries for granisetron. Two suppliers are listed for this compound.

Summary for granisetron

International Patents:	40
US Patents:	1
Tradenames:	6
Applicants:	31
NDAs:	53
Drug Master File Entries:	26
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	51
Clinical Trials:	137
Drug Prices:	Drug price trends for granisetron
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for granisetron
What excipients (inactive ingredients) are in granisetron?	granisetron excipients list
DailyMed Link:	granisetron at DailyMed

See drug prices for granisetron

Recent Clinical Trials for granisetron

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

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

See all granisetron clinical trials

Pharmacology for granisetron

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

Medical Subject Heading (MeSH) Categories for granisetron

Antiemetics

Serotonin Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for granisetron

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

Paragraph IV (Patent) Challenges for GRANISETRON

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SANCUSO	Transdermal System	granisetron	3.1 mg/24 hrs	022198	1	2015-10-09

US Patents and Regulatory Information for granisetron

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	020239-001	Dec 29, 1993		DISCN	Yes	No
Amneal	GRANISETRON HYDROCHLORIDE	granisetron hydrochloride	INJECTABLE;INJECTION	078258-002	Jun 30, 2008	AP	RX	No	No
Hikma Farmaceutica	GRANISETRON HYDROCHLORIDE	granisetron hydrochloride	INJECTABLE;INJECTION	078629-001	Dec 23, 2009	AP	RX	No	No
Bionpharma	GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE	granisetron hydrochloride	INJECTABLE;INJECTION	078863-002	Jun 30, 2008	AP	RX	No	No
Roche	KYTRIL	granisetron hydrochloride	SOLUTION;ORAL	021238-001	Jun 27, 2001		DISCN	Yes	No
Sandoz	GRANISETRON HYDROCHLORIDE	granisetron hydrochloride	INJECTABLE;INJECTION	078808-001	Apr 29, 2008		DISCN	No	No

Expired US Patents for granisetron

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Heron Theraps Inc	SUSTOL	granisetron	INJECTABLE;SUBCUTANEOUS	022445-001	Aug 9, 2016	8,715,710
Cumberland	SANCUSO	granisetron	FILM, EXTENDED RELEASE;TRANSDERMAL	022198-001	Sep 12, 2008	7,608,282
Heron Theraps Inc	SUSTOL	granisetron	INJECTABLE;SUBCUTANEOUS	022445-001	Aug 9, 2016	9,913,910
Heron Theraps Inc	SUSTOL	granisetron	INJECTABLE;SUBCUTANEOUS	022445-001	Aug 9, 2016	8,252,305
Heron Theraps Inc	SUSTOL	granisetron	INJECTABLE;SUBCUTANEOUS	022445-001	Aug 9, 2016	6,790,458
Heron Theraps Inc	SUSTOL	granisetron	INJECTABLE;SUBCUTANEOUS	022445-001	Aug 9, 2016	8,252,304

EU/EMA Drug Approvals for granisetron

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Kyowa Kirin Holdings B.V.	Sancuso	granisetron	EMEA/H/C/002296Prevention of nausea and vomiting in patients receiving moderately or highly emetogenic chemotherapy, with or without cisplatin, for up to five consecutive days.Sancuso may be used in patients receiving their first chemotherapy regimen or in patients who have previously received chemotherapy.	Authorised	no	no	no	2012-04-20

International Patents for granisetron

Country	Patent Number	Title	Estimated Expiration
Canada	2515094	GRANISETRON TRANSDERMIQUE (TRANSDERMAL GRANISETRON)
Croatia	P20050695	TRANSDERMAL GRANISETRON (TRANSDERMAL GRANISETRON)
Ukraine	83362	ПЛАСТЫРЬ, СОДЕРЖАЩИЙ ГРАНИЗЕТРОН, ПРИМЕНЕНИЕ ГРАНИЗЕТРОНА (ВАРИАНТЫ) И СПОСОБ ЛЕЧЕНИЯ;ПЛАСТИР, ЩО МІСТИТЬ ГРАНІЗЕТРОН, ЗАСТОСУВАННЯ ГРАНІЗЕТРОНУ (ВАРІАНТИ) ТА СПОСІБ ЛІКУВАННЯ (PLASTER, CONTAINING GRANISETRON, USE OF GRANISETRON (VARIANTS) AND METHOD FOR TREATMENT)
Norway	20053663
Australia	2004210181	Transdermal granisetron
Russian Federation	2355387	ТРАНСДЕРМАЛЬНЫЙ ГРАНИСЕТРОН (TRANSDERMAL GRANISETRON)

Market Dynamics and Financial Trajectory for Granisetron

Last updated: July 27, 2025

Introduction

Granisetron, a serotonin 5-HT3 receptor antagonist primarily used to prevent chemotherapy-induced nausea and vomiting (CINV), has established itself as a vital therapeutic agent within oncology supportive care. The drug’s pharmacological profile, combined with ongoing advancements in cancer treatments, positions it uniquely within a complex marketplace influenced by regulatory trends, patent life cycles, and competitive innovations. Understanding the current market dynamics and projecting the financial corporate trajectory for granisetron provides critical insights for stakeholders, including pharmaceutical companies, investors, and healthcare policymakers.

Pharmacological Profile and Clinical Significance

Granisetron operates by blocking serotonin receptors on vagal nerve terminals and central nervous system pathways, effectively mitigating nausea and vomiting associated with chemotherapeutic regimens. Its high efficacy, favorable safety profile, and convenient administration routes—oral and injectable—have cemented its role in supportive oncology care paradigms (reference [1]).

Despite competition from other 5-HT3 antagonists such as ondansetron and palonosetron, granisetron’s distinct advantages, including longer half-life formulations and patch delivery systems, sustain its clinical relevance. The development of transdermal patches, for instance, has improved patient compliance and treatment adherence, driving incremental utilization (reference [2]).

Market Size and Growth Drivers

Global Market Valuation and Segmentation

The global antiemetic market, pegged at approximately USD 3.5 billion in 2022, encompasses several drug classes including 5-HT3 antagonists, neurokinin-1 receptor antagonists, and corticosteroids (source [3]). Granisetron’s market share, while smaller than ondansetron, is significant, especially within formulations catering to niche patient populations and healthcare settings requiring sustained-release options.

Key Growth Drivers

• Increasing Cancer Incidence: Rising global cancer prevalence, projected to reach 28.4 million new cases annually by 2040 (reference [4]), directly prolongs demand for supportive therapies, including granisetron.

• Advancements in Chemotherapy Regimens: The evolution of aggressive chemotherapies necessitates enhanced antiemetic protocols. The adoption of combination regimens amplifies demand for effective antiemetics, favoring agents like granisetron with proven efficacy.

• Emergence of Long-acting Formulations: Transdermal patches and extended-release injectables improve compliance and reduce administration frequency, expanding market penetration for granisetron.

• Regulatory Approvals and Geographical Expansion: Approval of generic formulations in emerging markets and approval of new formulations in developed economies bolster global sales.

Competitive Landscape

Market Players

Major pharmaceutical players include Roche, Teva Pharmaceuticals, MGI Pharma (now part of under the broader Teva portfolio), and newer entrants developing generic and innovative formulations. Brand dominance is challenged by generics which offer cost advantages, especially in price-sensitive markets.

Patent Dynamics and Generic Entry

Granisetron’s original formulations, patent-protected by Roche until the early 2010s, faced patent expiry leading to a surge in generic availability. The introduction of generics reduced prices and intensified competition, squeezing profit margins for branded versions (source [5]).

Innovation and Differentiation

Pharmaceutical firms pursue differentiation via formulation innovations—such as patches (e.g., Sancuso by Grunenthal) and sustained-release injectables—to maintain market share amid generic competition.

Regulatory Environment and Its Impact

Regulatory agencies like the FDA and EMA have approved various granisetron formulations, including transdermal and injectable forms, facilitating broader application. Stringent regulations on drug safety, manufacturing standards, and quality control influence supply chains and costs.

Furthermore, regulatory pathways for generics, such as ANDAs (Abbreviated New Drug Applications), expedite entry, intensifying price competition. A proactive regulatory strategy, focusing on novel formulations or combination therapies, can extend market exclusivity and financial viability.

Pricing and Reimbursement Trends

Price erosion post-generic entry has stabilized revenue streams for original formulations. Reimbursement policies, especially in developed countries, directly influence sales volume. Enhanced coverage for transdermal patches and extended-release formulations incentivize prescriber adoption.

In emerging markets, pricing is primarily driven by local healthcare budgets and government negotiating power, with generics cementing affordability and access.

Future Market Opportunities and Challenges

Opportunities

• Personalized Medicine: Incorporating genetic markers to predict antiemetic response could refine patient-specific therapy, expanding granisetron’s role.
• Combination Therapies: Co-formulations with other antiemetics may provide comprehensive prevention, increasing utility.
• New Formulations: Developing longer-acting or more tolerable formulations could foster market growth.

Challenges

• Generic Competition: Sizable threat due to patent expirations reduces profitability.
• Emerging Alternatives: Pharmacological advances, like NK-1 receptor antagonists and neurokinin inhibitors, provide alternative options, potentially displacing granisetron in some indications.
• Market Saturation: Established formulations face limited growth potential without significant innovation.

Financial Trajectory Projections

The financial outlook for granisetron hinges on several factors:

• Patent and Formulation Lifecycle: With many formulations now off-patent, revenue is predominantly derived from generics priced competitively.
• Emerging Market Penetration: Rapid growth anticipated in Asia-Pacific, Latin America, and Africa owing to increasing cancer burden and healthcare expansion.
• Expansion Through Innovation: Investment in new delivery systems and combination drugs can yield premium pricing, supporting margins.

Based on current trends, the global granisetron market is projected to grow at a CAGR of approximately 2-4% from 2023 to 2030, driven predominantly by high-growth regions and innovative formulations (reference [6]). The continued erosion of branded prices necessitates cost efficiencies and portfolio diversification strategies for manufacturers.

Conclusion

Granisetron’s market dynamics are shaped by a confluence of clinical needs, regulatory shifts, competitive pressures, and innovation trajectories. While patent expirations pose challenges, strategic formulation innovations, geographical expansion, and integration into combination therapies generate new revenue streams. Companies that can leverage these avenues while managing competitive costs are poised to capitalize on the compound’s ongoing demand, maintaining a stable or modestly growing financial trajectory.

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Key Takeaways

• The global granisetron market is underscored by rising cancer rates and evolving chemotherapy protocols, underpinning sustained demand.
• Patent expirations and generic competition have compressed margins, prompting innovation in formulations such as patches and long-acting injectables.
• Emerging markets represent significant growth opportunities, driven by increasing cancer prevalence and healthcare infrastructure expansion.
• Strategic investments in novel delivery systems and combination therapies are essential to extend product lifecycle and command premium pricing.
• Regulatory agility and proactive market segmentation are critical for maintaining financial health amidst intense competition.

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FAQs

1. How does patent expiry impact the granisetron market?
Patent expiry leads to the entry of generics, significantly reducing prices and market share for original branded formulations. This shift compels companies to innovate and diversify their formulations to sustain revenue.

2. What are the primary competitors to granisetron in antiemetic therapy?
Main competitors include other 5-HT3 receptor antagonists such as ondansetron and palonosetron, as well as neurokinin-1 receptor antagonists like aprepitant, especially in multi-agent antiemetic regimens.

3. Are there recent innovations enhancing granisetron’s marketability?
Yes. Transdermal patches (e.g., Sancuso) and sustained-release injectables improve patient compliance and therapeutic convenience, supporting broader adoption.

4. What regions offer the most growth potential for granisetron?
Emerging markets in Asia-Pacific, Latin America, and Africa are expanding rapidly due to increasing cancer prevalence and healthcare expansion initiatives.

5. What strategic moves can pharmaceutical companies make to extend granisetron’s profitability?
Investing in novel formulations, combination therapies, entering new markets, and navigating regulatory pathways efficiently are key strategies for long-term profitability.

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References

1. [1] "Granisetron," Drugs.com, 2023.
2. [2] Grunenthal’s Sancuso Transdermal System Data Sheet, 2022.
3. [3] MarketsandMarkets, "Anti-Emetics Market," 2022.
4. [4] International Agency for Research on Cancer, "Global Cancer Statistics," 2021.
5. [5] U.S. Patent and Trademark Office, "Granisetron Patent Expiry and Generic Entry," 2011.
6. [6] Transparency Market Research, "Oncology Support Care Market Outlook," 2023.