KYTRIL Drug Patent Profile

When do Kytril patents expire, and what generic alternatives are available?

Kytril is a drug marketed by Roche and is included in three NDAs.

The generic ingredient in KYTRIL is granisetron hydrochloride. There are twenty-six drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the granisetron hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Kytril

A generic version of KYTRIL was approved as granisetron hydrochloride by AMNEAL on December 31^st, 2007.

Summary for KYTRIL

US Patents:	0
Applicants:	1
NDAs:	3
Raw Ingredient (Bulk) Api Vendors:	116
Clinical Trials:	20
Patent Applications:	5,014
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for KYTRIL
DailyMed Link:	KYTRIL at DailyMed

Recent Clinical Trials for KYTRIL

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

Sponsor	Phase
The University of The West Indies	Early Phase 1
Rutgers University	N/A
National Institute of General Medical Sciences (NIGMS)	N/A

See all KYTRIL clinical trials

Paragraph IV (Patent) Challenges for KYTRIL

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 KYTRIL

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	020239-003	Sep 17, 2004		DISCN	Yes	No
Roche	KYTRIL	granisetron hydrochloride	TABLET;ORAL	020305-002	Jun 15, 1998		DISCN	Yes	No
Roche	KYTRIL	granisetron hydrochloride	INJECTABLE;INJECTION	020239-002	Mar 11, 1994		DISCN	Yes	No
Roche	KYTRIL	granisetron hydrochloride	INJECTABLE;INJECTION	020239-004	Mar 11, 1994		DISCN	Yes	No
Roche	KYTRIL	granisetron hydrochloride	INJECTABLE;INJECTION	020239-001	Dec 29, 1993		DISCN	Yes	No
Roche	KYTRIL	granisetron hydrochloride	TABLET;ORAL	020305-001	Mar 16, 1995		DISCN	Yes	No

Expired US Patents for KYTRIL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Roche	KYTRIL	granisetron hydrochloride	INJECTABLE;INJECTION	020239-002	Mar 11, 1994
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	INJECTABLE;INJECTION	020239-003	Sep 17, 2004
Roche	KYTRIL	granisetron hydrochloride	INJECTABLE;INJECTION	020239-001	Dec 29, 1993
Roche	KYTRIL	granisetron hydrochloride	SOLUTION;ORAL	021238-001	Jun 27, 2001

International Patents for KYTRIL

See the table below for patents covering KYTRIL around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	3792251
Hungary	214629	Eljárás műtét utáni hányinger és hányás kezelésére szolgáló gyógyszerkészítmény előállítására (PROCESS FOR PRODUCING PHARMACEUTICAL COMPOSITION FOR THE TREATMENT OF POST-OPERATIVE NAUSEA AND VOMITING)
Denmark	191186
Bulgaria	61324
Denmark	170166
Portugal	82463	PROCESSO PARA A PREPARACAO DE NOVOS DERIVADOS DE AZA-INDOLE E DE COMPOSICOES FARMCEUTICAS QUE OS CONTEM

KYTRIL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: KYTRIL

Introduction to KYTRIL

KYTRIL, generically known as granisetron, is a potent antiemetic drug used primarily to prevent and treat nausea and vomiting induced by chemotherapy and radiation therapy. It belongs to the class of 5-HT3 receptor antagonists.

Market Size and Growth

The global market for granisetron, including KYTRIL, is experiencing significant growth. As of 2023, the global CINV (Chemotherapy-Induced Nausea and Vomiting) existing and pipeline drugs market, which includes granisetron, was valued at USD 1.62 billion and is expected to grow at a CAGR of 4.9% from 2024 to 2030, reaching USD 2.27 billion by 2030[1].

Key Drivers of the Market

Rise in Cancer Cases

One of the primary drivers of the granisetron market is the increasing prevalence of cancer cases. Nearly 70% to 80% of cancer patients experience chemotherapy-induced nausea and vomiting (CINV), and 50% to 80% experience radiation-induced nausea and vomiting (RNIV). This high incidence of CINV and RNIV among cancer patients significantly boosts the demand for granisetron[4].

Healthcare Expenditure and Reimbursement Policies

High healthcare expenditure per capita and favorable medical reimbursement policies in developed nations also contribute to the growth of the granisetron market. These factors enable more patients to access and afford antiemetic treatments, including KYTRIL[4].

Post-Operative Applications

Granisetron is increasingly used in post-operative surgical procedures to prevent and treat nausea and vomiting. This expanded application further drives the market growth[4].

Market Segments

The granisetron market is segmented based on several factors:

Type

The market is categorized by the type of granisetron formulation, such as 1ml/Piece and 3ml/Piece injections[3].

Application

Granisetron is used in various settings, including hospital pharmacies, retail pharmacies, and other healthcare facilities[3].

End Use

The CINV market, which includes KYTRIL, is segmented by end use into hospitals, specialty clinics, hospital pharmacies, and drugstores[1].

Financial Performance

Revenue Trends

The financial performance of companies involved in the granisetron market reflects the overall growth trends. For instance, while specific financial data for KYTRIL is not isolated, the broader CINV market and related pharmaceutical companies show steady revenue. Karyopharm, a company involved in the development and marketing of various pharmaceuticals, reported total revenue of $146.0 million for the year ended December 31, 2023, although this is not exclusively from granisetron sales[2].

R&D Investments

Increased R&D investments by pharmaceutical and biotechnology companies for developing highly effective and efficient drugs with minimal side effects are projected to fuel demand for granisetron. These investments indicate a strong financial commitment to improving antiemetic treatments, including KYTRIL[4].

Challenges and Restraints

Side Effects

Despite its efficacy, granisetron has several severe side effects, including anxiety, trouble sleeping, and drowsiness. These side effects can restrain market growth as patients and healthcare providers seek alternative treatments with fewer adverse effects[4].

COVID-19 Impact

The COVID-19 pandemic had a limited but notable impact on the granisetron market. Supply chain disruptions and the illness of healthcare workers led to temporary shortages. However, the pandemic also highlighted the importance of robust healthcare systems and the need for effective antiemetic treatments, which could offset some of the negative impacts[4].

Market Trends

Personalized Medicine and OTC Products

There is an increasing demand for personalized medicine and over-the-counter (OTC) products, which presents opportunities for the granisetron market. As patients seek more tailored and accessible treatments, manufacturers are likely to innovate and expand their product lines[4].

Geographical Expansion

The granisetron market is expanding across various geographical regions, including North America, Europe, Asia-Pacific, South America, and the Middle-East and Africa. This geographical diversification is driven by the global increase in cancer cases and the need for effective antiemetic treatments[3].

Key Companies

Several companies are profiled in the granisetron market report, including Shanxi PUDE Pharmaceutical, Zhejiang Hisun Pharmaceutical, and others. These companies are key players in the manufacturing and distribution of granisetron injections and other formulations[3].

Future Outlook

The future outlook for the granisetron market, including KYTRIL, is promising. With the projected growth rate and increasing demand driven by rising cancer cases and improved healthcare infrastructure, the market is poised for significant expansion.

"Nearly 70% to 80 % of cancer patients are affected by chemotherapy-induced nausea and vomiting (CINV) and 50% to 80% patients are affected by radiation-induced nausea and vomiting (RNIV)"[4].

Key Takeaways

• The global CINV market, which includes KYTRIL, is expected to grow at a CAGR of 4.9% from 2024 to 2030.
• The rise in cancer cases and favorable healthcare expenditure and reimbursement policies are key drivers of the market.
• Granisetron is increasingly used in post-operative surgical procedures.
• The market faces challenges from side effects and past disruptions due to the COVID-19 pandemic.
• There is a growing demand for personalized medicine and OTC products.
• Geographical expansion is a significant trend in the granisetron market.

FAQs

Q: What is the primary use of KYTRIL (granisetron)?

A: KYTRIL (granisetron) is primarily used to prevent and treat nausea and vomiting induced by chemotherapy and radiation therapy.

Q: What is the expected growth rate of the CINV market, which includes KYTRIL?

A: The CINV market is expected to grow at a CAGR of 4.9% from 2024 to 2030[1].

Q: Which factors drive the demand for granisetron?

A: The rise in cancer cases, high healthcare expenditure per capita, and favorable medical reimbursement policies are key drivers of the granisetron market[4].

Q: What are some of the severe side effects of granisetron?

A: Granisetron can cause severe side effects including anxiety, trouble sleeping, and drowsiness[4].

Q: How has the COVID-19 pandemic affected the granisetron market?

A: The COVID-19 pandemic caused temporary supply chain disruptions and shortages but also highlighted the need for robust healthcare systems and effective antiemetic treatments[4].

Sources

1. Maximize Market Research, "CINV Existing and Pipeline Drugs Market: Global Industry Analysis".
2. Karyopharm, "Karyopharm Reports Fourth Quarter and Full Year 2023 Financial Results and Highlights Recent Company Progress".
3. Market Research Intellect, "Global Granisetron Hydrochloride Injection Market Size, Scope And Forecast".
4. Allied Market Research, "Granisetron Market Size, Growth, Share, Industry Insight 2030".