GRANISETRON - Generic Drug Details

What are the generic drug sources for granisetron and what is the scope of patent protection?

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. Additional information is available in the individual branded drug profile pages.

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

Summary for GRANISETRON

US Patents:	0
Tradenames:	6
Applicants:	31
NDAs:	53
Drug Master File Entries:	26
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	51
Clinical Trials:	139
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
Assiut University	PHASE4
Ataturk University	NA
Meri Mirceta	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
Yung Shin Pharm	GRANISETRON HYDROCHLORIDE	granisetron hydrochloride	INJECTABLE;INJECTION	202648-002	Jun 29, 2020		DISCN	No	No
Hikma	GRANISETRON HYDROCHLORIDE	granisetron hydrochloride	INJECTABLE;INJECTION	077187-001	Jun 30, 2008	AP	RX	No	No
Barr	GRANISETRON HYDROCHLORIDE	granisetron hydrochloride	TABLET;ORAL	078221-001	Dec 31, 2007		DISCN	No	No
Fresenius Kabi Usa	GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE	granisetron hydrochloride	INJECTABLE;INJECTION	078096-001	Jun 30, 2008	AP	RX	No	Yes
Fresenius Kabi Usa	GRANISETRON HYDROCHLORIDE	granisetron hydrochloride	INJECTABLE;INJECTION	078522-001	Dec 31, 2007	AP	RX	No	No
Wockhardt Usa	GRANISETRON HYDROCHLORIDE	granisetron hydrochloride	INJECTABLE;INJECTION	078566-001	Feb 29, 2008		DISCN	No	No
Sandoz	GRANISETRON HYDROCHLORIDE	granisetron hydrochloride	INJECTABLE;INJECTION	078534-001	Apr 30, 2009	AP	RX	No	No

Expired US Patents for GRANISETRON

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
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	8,252,305
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	10,357,570
Heron Theraps Inc	SUSTOL	granisetron	INJECTABLE;SUBCUTANEOUS	022445-001	Aug 9, 2016	8,252,304
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	6,613,355

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

GRANISETRON Market Analysis and Financial Projection

Last updated: February 13, 2026

What Are the Market Dynamics for Granisetron?

Granisetron, a 5-HT3 receptor antagonist, treats chemotherapy-induced nausea and vomiting (CINV). Its market is shaped by oncology drug policies, therapeutic alternatives, and patient demographics.

Key Market Drivers

• Growing Cancer Incidence: Global cancer cases reached approximately 19 million in 2020, projected to increase annually. This elevates demand for antiemetics, including granisetron.
• Advancements in Chemotherapy Protocols: Enhanced cancer treatments include higher-emetogenic potential, increasing reliance on effective anti-nausea agents.
• Regulatory Approvals and Formulations: Approval of transdermal and extended-release formulations enhances compliance and broadens utilization.
• Generic drug penetration: Price competition rises with patents expiring, expanding access in developing markets.

Market Restraints

• Availability of Alternatives: Ondansetron, palonosetron, and NK1 receptor antagonists compete in the same therapeutic space.
• Side Effect Profile: Headache, constipation, and rare ECG changes impact prescribing patterns.
• Pricing and Reimbursement: Variations across regions impact market penetration, especially where biosimilars are introduced.
• Regulatory Barriers: Stringent approval processes and regional licensing delays slow market expansion in certain countries.

Regional Market Overview

Region	Market Share (%)	Key Factors
North America	50	High cancer prevalence, advanced healthcare systems
Europe	25	Growing oncology treatments, reimbursement policies
Asia-Pacific	15	Emerging markets, expanding healthcare infrastructure
Rest of World	10	Limited access, regulatory delays

What Is the Financial Trajectory for Granisetron?

Granisetron's sales are driven by volume growth rather than price increases, with global revenues estimated in the hundreds of millions of dollars.

Revenue Estimates and Market Share

• Global Market Size: The antiemetics market was valued at approximately $4 billion in 2021, with granisetron accounting for roughly 10-15%.
• Key Players: Teva, Janssen (J&J), Mylan, and Sun Pharmaceutical dominate sales with generics making up around 70% of the market.
• Growth Rate: Compound annual growth rate (CAGR) projected between 3% and 5% from 2022 to 2027.

Key Revenue Factors

• Patent Expiry: Most patents expired between 2018–2020, increasing generic availability and reducing prices.
• Pricing Trends: Prices for branded formulations remain higher; generics are priced 40–60% lower.
• Regional Variances: High in North America and Europe; lower in emerging markets due to pricing and reimbursement challenges.

Investment and Development Considerations

• Pipeline Developments: Slight innovation in delivery mechanisms can extend market life.
• Regulatory Trends: Simplified approval pathways in some countries may accelerate generic entry.
• Market Penetration: Off-label uses in other types of nausea or vomiting could expand sales.

How Do Market Factors Impact Financial Trajectory?

• Generic Competition: Drives down prices, compresses margins, but enlarges market volume.
• Pricing Policies: Favorable reimbursement policies sustain sales in regions with high cancer care intensity.
• Manufacturing Costs: Stable for established formulations; new delivery systems may incur R&D expenses.
• Market Expansion: Geographic diversification boosts revenues, especially in underserved regions.

Key Takeaways

• The global granisetron market is subject to growth propelled by rising cancer incidences and improved treatment protocols.
• Price competition from generics depresses revenue per unit but expands overall sales volume.
• Market shares are concentrated in North America and Europe, with Asia-Pacific offering growth potential due to healthcare infrastructure development.
• Regulatory shifts and pipeline innovations may influence future revenue streams.

FAQs

1. Will patents for granisetron significantly impact its market longevity?
Most patents expired between 2018–2020, leading to increased generic competition and price reductions, which could suppress branded sales but expand overall market size.

2. How do alternative antiemetics influence granisetron sales?
Availability of drugs like palonosetron and NK1 antagonists creates competitive pressure, encouraging differentiation through formulation or delivery methods.

3. Is there growth potential outside traditional markets?
Yes; emerging markets in Asia and Latin America show rising cancer rates and expanding healthcare access, offering future growth opportunities.

4. What impact do new formulations have?
Transdermal patches and extended-release formulations can improve compliance, potentially increasing market share in specific patient groups.

5. How might regulatory policies change in the future?
Streamlined approval pathways, especially for generics, could facilitate faster market entry, affecting pricing and competition dynamics.

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Sources:
[1] Global Cancer Statistics 2020, International Agency for Research on Cancer.
[2] Anti-emetics Market, Market Research Future, 2022.
[3] U.S. Food and Drug Administration, Approved Drugs Database.
[4] IMS Health, Pharmaceutical Market Data, 2021.