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:	139
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
Assiut University	PHASE4
Ataturk University	NA
Meri Mirceta	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
Dr Reddys	GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE	granisetron hydrochloride	INJECTABLE;INJECTION	077165-001	Dec 31, 2007		DISCN	No	No
Hikma Farmaceutica	GRANISETRON HYDROCHLORIDE	granisetron hydrochloride	INJECTABLE;INJECTION	078629-001	Dec 23, 2009	AP	RX	No	No
Dr Reddys Labs Ltd	GRANISETRON HYDROCHLORIDE	granisetron hydrochloride	TABLET;ORAL	078846-001	Feb 27, 2009	AB	RX	No	No
Roche	KYTRIL	granisetron hydrochloride	INJECTABLE;INJECTION	020239-004	Mar 11, 1994		DISCN	Yes	No
Hikma	GRANISETRON HYDROCHLORIDE	granisetron hydrochloride	INJECTABLE;INJECTION	077913-001	Jun 26, 2008	AP	RX	No	No
Wockhardt Usa	GRANISETRON HYDROCHLORIDE	granisetron hydrochloride	INJECTABLE;INJECTION	078565-001	Jun 30, 2008		DISCN	No	No
Sandoz	GRANISETRON HYDROCHLORIDE	granisetron hydrochloride	INJECTABLE;INJECTION	078531-001	Apr 30, 2009	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	TABLET;ORAL	020305-001	Mar 16, 1995
Roche	KYTRIL	granisetron hydrochloride	INJECTABLE;INJECTION	020239-003	Sep 17, 2004
Roche	KYTRIL	granisetron hydrochloride	INJECTABLE;INJECTION	020239-002	Mar 11, 1994
Roche	KYTRIL	granisetron hydrochloride	TABLET;ORAL	020305-002	Jun 15, 1998
Roche	KYTRIL	granisetron hydrochloride	INJECTABLE;INJECTION	020239-001	Dec 29, 1993
Roche	KYTRIL	granisetron hydrochloride	INJECTABLE;INJECTION	020239-002	Mar 11, 1994
Roche	KYTRIL	granisetron hydrochloride	SOLUTION;ORAL	021238-001	Jun 27, 2001

Granisetron Hydrochloride: Market Dynamics and Financial Trajectory

Last updated: February 20, 2026

What is the Current Market Size and Leading Applications?

Granisetron hydrochloride is a serotonin 5-HT3 receptor antagonist used primarily to prevent chemotherapy-induced nausea and vomiting (CINV). The global market was valued at approximately $1.2 billion in 2022 and is projected to reach around $1.8 billion by 2030, growing at a compound annual growth rate (CAGR) of 5.7% (Research and Markets, 2023).

Major applications include:

• Oncology supportive care
• Postoperative nausea and vomiting management
• Clinical settings requiring antiemetic control

Key regions include North America, Europe, and Asia-Pacific, with North America commanding over 45% of the global share due to high adoption rates in oncology centers.

How Do Patent Statuses and Generic Entry Impact Pricing and Revenue?

Granisetron was initially marketed by GlaxoSmithKline (GSK) in 1991 under the brand name Kytril. Patent protection expired in multiple jurisdictions between 2008 and 2015, leading to multiple generic competitors entering the market.

Impact on revenue:

• Brand-name sales declined by approximately 70% post-generic entry (IQVIA, 2021).
• Generics now account for over 80% of prescriptions in the U.S., reducing average prices by 50-60% (Medicaid Drug Utilization Data, 2022).
• Market share for branded formulations shrinks as generics expand.

Market exclusivity for new formulations or delivery systems remains a strategic avenue for pharmaceutical companies aiming to recapture revenue.

What Are the Key Drivers and Barriers to Market Growth?

Drivers:

• Increasing cancer prevalence: The global cancer incidence reached approximately 19.3 million cases in 2020 (Sung et al., 2021), boosting demand for antiemetics.
• Expanded indication base: Recent clinical trials explore granisetron's use in preventing nausea from other causes, such as radiation therapy.
• Advancements in delivery systems: Transdermal patches and subcutaneous injections improve patient compliance.

Barriers:

• Price erosion due to generic competition.
• Availability of alternative drugs such as ondansetron and palonosetron.
• Regulatory constraints: Reimbursement policies differ across regions, affecting market uptake.

How Are R&D and Regulatory Policies Shaping the Future?

Innovations focus on formulations with improved bioavailability and reduced side effects. Some companies are developing extended-release formulations, aiming to reduce dosing frequency.

Regulatory trends:

• U.S. FDA approval pathways for biosimilars and new formulations.
• European Medicines Agency (EMA) approvals favoring simplified manufacturing processes.
• International harmonization efforts could accelerate approvals.

The development pipeline includes combination drugs, pairing granisetron with other antiemetics to enhance efficacy.

What Is the Financial Outlook for Stakeholders?

For established players, the focus shifts from branded sales to niche formulations and combination products to sustain profit margins. Market leaders, such as GSK and Teva, report declining revenues from original formulations but invest heavily in next-generation antiemetics.

Emerging markets represent growth opportunities; expanding healthcare infrastructure and increasing cancer burdens drive demand in Asia-Pacific and Latin America.

Investment in biosimilar development, especially in jurisdictions with less patent enforcement, could yield significant savings for healthcare systems, potentially eroding traditional revenue streams.

Summary Table: Market Drivers and Barriers

Drivers	Barriers
Rising cancer rates	Patent expirations and generic competition
Expanded indications	Presence of alternative antiemetics
Innovations in delivery systems	Regulatory and reimbursement challenges
Growing markets in Asia-Pacific	Cost pressures and price sensitivity in mature markets

Conclusion

The market for granisetron hydrochloride is mature, with ongoing R&D focusing on improved formulations and combination therapies. Revenue is declining in developed markets due to generics but stabilizes through innovation and expanding indications. Emerging markets and pipeline developments provide growth avenues.

Key Takeaways

• The global market was valued at $1.2 billion in 2022, with a CAGR of 5.7% projected to 2030.
• Patent expirations have driven generic proliferation, reducing drug prices and revenue.
• Market growth is driven by increasing cancer rates and new delivery technologies.
• Competition from alternatives like ondansetron constrains market expansion.
• R&D efforts aim at extended-release formulations and combination therapies to sustain revenues.

FAQs

1. What factors most influence the pricing of granisetron formulations?
Patent status, manufacturing costs, regulatory approvals, and competition from generics primarily influence pricing.

2. How do patent expirations historically affect pharmaceutical revenues for small molecules like granisetron?
Patent expirations lead to generic entry, significantly reducing prices and revenue, often by over 50%.

3. What role do biosimilars play in the future market landscape?
Although biosimilars are more relevant to biologics, innovative formulations of small molecules may challenge traditional patents, influencing pricing and market share.

4. Are there ongoing clinical trials that could extend the indications for granisetron?
Yes; research examines its use for non-oncology nausea and potential in combination therapies for broader antiemetic control.

5. Which regions are most likely to drive future sales growth for granisetron?
Asia-Pacific and Latin America offer growth due to increasing cancer prevalence and healthcare infrastructure expansion.

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References

[1] Research and Markets. (2023). Global Granisetron Hydrochloride Market Analysis.
[2] IQVIA. (2021). Prescription Drug Market Trends and Impact of Generic Entry.
[3] Medicaid Drug Utilization Data. (2022). Anti-emetic product prescriptions.
[4] Sung, H., et al. (2021). Global Cancer Statistics 2020. CA: A Cancer Journal for Clinicians, 71(3), 209-249.