Granisetron - Generic Drug Details

What are the generic 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, Norvium Bioscience, 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-two NDAs. There are six patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Granisetron has fifty-eight patent family members in thirty-two countries.

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

Summary for granisetron

International Patents:	58
US Patents:	6
Tradenames:	6
Applicants:	31
NDAs:	52
Drug Master File Entries:	26
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	51
Clinical Trials:	125
Patent Applications:	7,564
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

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for granisetron

Dosage:

FILM, EXTENDED RELEASE;TRANSDERMAL

^*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.

Recent Clinical Trials for granisetron

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

Sponsor	Phase
Second Affiliated Hospital, School of Medicine, Zhejiang University	Phase 4
Guangxi Medical University	Phase 3
Heron Therapeutics	Phase 4

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
Amneal	GRANISETRON HYDROCHLORIDE	granisetron hydrochloride	INJECTABLE;INJECTION	078258-002	Jun 30, 2008	AP	RX	No	No
Yung Shin Pharm	GRANISETRON HYDROCHLORIDE	granisetron hydrochloride	INJECTABLE;INJECTION	202648-002	Jun 29, 2020		DISCN	No	No
Hikma	GRANISETRON HYDROCHLORIDE	granisetron hydrochloride	INJECTABLE;INJECTION	077177-001	Dec 31, 2007	AP	RX	No	No
Fresenius Kabi Usa	GRANISETRON HYDROCHLORIDE	granisetron hydrochloride	INJECTABLE;INJECTION	078522-001	Dec 31, 2007	AP	RX	No	No
Natco Pharma	GRANISETRON HYDROCHLORIDE	granisetron hydrochloride	TABLET;ORAL	078969-001	Jun 22, 2009	AB	RX	No	No
Barr	GRANISETRON HYDROCHLORIDE	granisetron hydrochloride	TABLET;ORAL	078221-001	Dec 31, 2007		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
Heron Theraps Inc	SUSTOL	granisetron	INJECTABLE;SUBCUTANEOUS	022445-001	Aug 9, 2016
Heron Theraps Inc	SUSTOL	granisetron	INJECTABLE;SUBCUTANEOUS	022445-001	Aug 9, 2016
Heron Theraps Inc	SUSTOL	granisetron	INJECTABLE;SUBCUTANEOUS	022445-001	Aug 9, 2016
Heron Theraps Inc	SUSTOL	granisetron	INJECTABLE;SUBCUTANEOUS	022445-001	Aug 9, 2016
Heron Theraps Inc	SUSTOL	granisetron	INJECTABLE;SUBCUTANEOUS	022445-001	Aug 9, 2016

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/002296 Prevention 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
European Patent Office	3424492	VÉHICULE D'ADMINISTRATION SEMI-SOLIDE ET COMPOSITIONS PHARMACEUTIQUES (SEMI-SOLID DELIVERY VECHICLE AND PHARMACEUTICAL COMPOSITIONS)
Israel	169881	ADHESIVE PATCHES FOR THE TRANSDERMAL DELIVERY OF GRANISETRON
Australia	2004210181	Transdermal granisetron
Taiwan	200616650	Semi-solid delivery vehicle and pharmaceutical compositions
Serbia	51696	TRANSDERMALNI GRANISETRON (TRANSDERMAL GRANISETRON)
New Zealand	541103	Adhesive patchs for transdermal administration of granisetron

Granisetron Market Analysis and Financial Projection Experimental

Granisetron Market Dynamics and Financial Trajectory

Market Overview

Granisetron, a selective serotonin 5-HT3 receptor antagonist, is primarily used to prevent nausea and vomiting caused by cancer treatments such as chemotherapy and radiation therapy, as well as post-operative surgical procedures. The market for granisetron is poised for significant growth, driven by several key factors.

Market Drivers

Rise in Chemotherapy and Radiotherapy Visits

The increasing incidence of cancer globally is a major driver for the granisetron market. As more patients undergo chemotherapy and radiotherapy, the demand for antiemetic medications like granisetron to manage chemotherapy-induced nausea and vomiting (CINV) is expected to rise[3][4].

Increasing Incidence of Gastroparesis

Gastroparesis, a condition characterized by delayed stomach emptying, also necessitates the use of granisetron. The growing prevalence of this condition further bolsters the demand for granisetron[4].

Advanced Delivery Systems

Innovations in drug delivery systems, such as transdermal patches and oral dissolvable films, are enhancing patient convenience and adherence. These advancements are expected to drive market growth by improving therapeutic outcomes and patient compliance[3].

Personalized Medicine

The trend towards personalized medicine, where treatment protocols are tailored based on genetic profiles, is increasing the demand for granisetron. This approach improves therapeutic outcomes and fosters higher demand for targeted antiemetic treatments[3].

High Healthcare Expenditure and Favorable Reimbursement Policies

High healthcare expenditure per capita and favorable medical reimbursement policies in developed nations have contributed significantly to the growth of the granisetron market. These factors enable more patients to access and afford granisetron treatments[1].

Market Restraints

Adverse Effects of Granisetron

Despite its efficacy, granisetron is associated with several adverse effects, including anxiety, trouble sleeping, and drowsiness. These side effects can restrain market growth as patients and healthcare providers may opt for alternative treatments with fewer side effects[1][4].

COVID-19 Impact

The COVID-19 pandemic has had a limited but significant impact on the granisetron market. Supply chain disruptions, shutdowns in affected countries, and the illness of healthcare workers have led to temporary shortages of granisetron. However, the overall impact has been managed, and the market is expected to recover and grow in the forecast period[1].

Market Segmentation

By Product Type

The granisetron market is segmented into several product types, including:

• Transdermal System: Transdermal patches are gaining popularity due to their convenience and ease of use. This segment is expected to experience significant growth in the near future[3][4].
• Injection: Injectable forms of granisetron are widely used in clinical settings, particularly for acute cases of nausea and vomiting.
• Oral: Oral tablets and dissolvable films are also popular, offering patients a range of options based on their preferences and needs[3].

By Application

• Chemotherapy: The primary application of granisetron is in the prevention and treatment of CINV. This segment drives the majority of the market demand.
• Post-operative: Granisetron is also used to prevent post-operative nausea and vomiting (PONV), further expanding its market scope[4].

By Geography

• North America: This region is anticipated to experience notable growth due to the high cancer burden and the increasing adoption of granisetron among patients undergoing chemotherapy and radiotherapy[4].
• Asia-Pacific: This region is expected to be the fastest-growing market, driven by increasing healthcare expenditure and a rising incidence of cancer[4].

Competitive Landscape

The granisetron market is characterized by a semi-consolidated structure with several key players:

• Kyowa Kirin Co. Ltd: Known for its robust portfolio of pharmaceuticals, including granisetron.
• Heron Therapeutics: Focused on strengthening its product portfolio and expanding its business globally.
• Fresenius SE & Co. KGaA: Provides a wide range of products and services, including injectable drugs and infusion therapies.
• Hikma Pharmaceuticals: A major player in the generic medications market.
• Teva Pharmaceutical Industries: One of the largest generic drug manufacturers, with significant investments in research and development[3][4].

Financial Trajectory

Market Size and Growth Rate

The granisetron market is expected to register a compound annual growth rate (CAGR) of approximately 6.20% to 6.50% during the forecast period from 2024 to 2031. This growth is driven by the increasing incidence of cancer, advancements in drug formulations, and favorable healthcare policies[3][4].

Revenue and Market Share

The global granisetron market size was significant in 2023 and is projected to grow substantially over the forecast period. Key players are expected to maintain and expand their market share through strategic initiatives such as new product launches, acquisitions, and investments in research and development[2][4].

Regional Revenue Share

North America is currently the largest market for granisetron, followed by Europe and Asia-Pacific. The Asia-Pacific region is expected to be the fastest-growing market due to its increasing healthcare expenditure and rising cancer incidence[4].

Key Takeaways

• The granisetron market is driven by the increasing prevalence of cancer and the subsequent rise in chemotherapy and radiotherapy treatments.
• Advanced delivery systems and personalized medicine are enhancing market growth.
• Adverse effects of granisetron and COVID-19 disruptions are key restraints.
• The market is semi-consolidated with key players focusing on strategic initiatives to strengthen their market position.
• North America and Asia-Pacific are significant regions driving market growth.

FAQs

What is the primary use of granisetron?

Granisetron is primarily used to prevent nausea and vomiting caused by cancer treatments such as chemotherapy and radiation therapy, as well as post-operative surgical procedures.

What are the key drivers of the granisetron market?

The key drivers include the rise in chemotherapy and radiotherapy visits, increasing incidence of gastroparesis, and advancements in drug delivery systems.

Which region is expected to be the fastest-growing market for granisetron?

The Asia-Pacific region is expected to be the fastest-growing market due to increasing healthcare expenditure and a rising incidence of cancer.

What are the common adverse effects of granisetron?

Common adverse effects include anxiety, trouble sleeping, and drowsiness.

Who are the major players in the granisetron market?

Key players include Kyowa Kirin Co. Ltd, Heron Therapeutics, Fresenius SE & Co. KGaA, Hikma Pharmaceuticals, and Teva Pharmaceutical Industries.

Sources

1. Allied Market Research - Granisetron Market Size, Growth, Share, Industry Insight 2030
2. Cognitive Market Research - Granisetron Base Market Report 2024 (Global Edition)
3. OpenPR - Granisetron Market Size & Share Analysis - Growth Trends & Forecasts (2024 - 2031)
4. Mordor Intelligence - Granisetron Market Size - Mordor Intelligence
5. PubMed - The dose-response relation and cost-effectiveness of granisetron for preventing PONV after pediatric outpatient surgery.