HYCAMTIN Drug Patent Profile

Which patents cover Hycamtin, and when can generic versions of Hycamtin launch?

Hycamtin is a drug marketed by Sandoz and is included in two NDAs. There is one patent protecting this drug.

This drug has eighteen patent family members in sixteen countries.

The generic ingredient in HYCAMTIN is topotecan hydrochloride. There are ten drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the topotecan hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Hycamtin

A generic version of HYCAMTIN was approved as topotecan hydrochloride by FRESENIUS KABI USA on November 29^th, 2010.

Summary for HYCAMTIN

International Patents:	18
US Patents:	1
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	108
Clinical Trials:	118
Patent Applications:	6,579
Drug Prices:	Drug price information for HYCAMTIN
What excipients (inactive ingredients) are in HYCAMTIN?	HYCAMTIN excipients list
DailyMed Link:	HYCAMTIN at DailyMed

See drug prices for HYCAMTIN

Recent Clinical Trials for HYCAMTIN

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

Sponsor	Phase
Verastem, Inc.	Phase 3
GOG Foundation	Phase 3
European Network of Gynaecological Oncological Trial Groups (ENGOT)	Phase 3

See all HYCAMTIN clinical trials

Pharmacology for HYCAMTIN

Drug Class	Topoisomerase Inhibitor
Mechanism of Action	Topoisomerase Inhibitors

US Patents and Regulatory Information for HYCAMTIN

HYCAMTIN is protected by one US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sandoz	HYCAMTIN	topotecan hydrochloride	CAPSULE;ORAL	020981-001	Oct 11, 2007		RX	Yes	No			Y
Sandoz	HYCAMTIN	topotecan hydrochloride	CAPSULE;ORAL	020981-002	Oct 11, 2007		RX	Yes	Yes			Y
Sandoz	HYCAMTIN	topotecan hydrochloride	INJECTABLE;INJECTION	020671-001	May 28, 1996	AP	RX	Yes	Yes

Expired US Patents for HYCAMTIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sandoz	HYCAMTIN	topotecan hydrochloride	INJECTABLE;INJECTION	020671-001	May 28, 1996
Sandoz	HYCAMTIN	topotecan hydrochloride	CAPSULE;ORAL	020981-001	Oct 11, 2007
Sandoz	HYCAMTIN	topotecan hydrochloride	INJECTABLE;INJECTION	020671-001	May 28, 1996
Sandoz	HYCAMTIN	topotecan hydrochloride	CAPSULE;ORAL	020981-002	Oct 11, 2007
Sandoz	HYCAMTIN	topotecan hydrochloride	CAPSULE;ORAL	020981-002	Oct 11, 2007

International Patents for HYCAMTIN

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

Country	Patent Number	Title	Estimated Expiration
Taiwan	200530250	Novel compound, corresponding compositions, preparation and/or treatment methods
Japan	2007510751
Russian Federation	2006120422	НОВОЕ СОЕДИНЕНИЕ, СООТВЕТСТВУЮЩИЕ КОМПОЗИЦИИ, СПОСОБЫ ПОЛУЧЕНИЯ И/ИЛИ СПОСОБЫ ЛЕЧЕНИЯ
Germany	3855575
Canada	1308102	ANALOGUES HYDROSOLUBLES DE LA CAMPTOTHECINE (WATER SOLUBLE CAMPTOTHECIN ANALOGS)

Supplementary Protection Certificates for HYCAMTIN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0321122	2/1997	Austria		PRODUCT NAME: TOPOTECAN; NAT. REGISTRATION NO/DATE: EU/1/96/027/001 EU/1/96/027/002 19961112; FIRST REGISTRATION: LI 53857 01 19961016
0321122	SPC/GB96/057	United Kingdom		PRODUCT NAME: TOPOTECAN; REGISTERED: CH IKS-NR:53857 19961016; UK EU/1/96/027/001 19961112; UK EU/1/96/027/002 19961112
0321122	C970017	Netherlands		PRODUCT NAME: TOPOTECAN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARD BAAR ZOUT, HYDRAAT OF SOLVAAT, IN HET BIJZONDER HET HYDROCHLORI DE; NAT. REGISTRATION NO/DATE: EU/1/96/027/001 - EU/1/96/027/002 19961112; FIRST REGISTRATION: CH IKS 53857 19961016
0321122	97C0009	Belgium		PRODUCT NAME: TOPOTECAN HYDROCHLORIDE; NAT. REGISTRATION NO/DATE: EU/1/96/027/001 19961112 ; FIRST REGISTRATION: CH 53857 19961016

HYCAMTIN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Hycamtin (Topotecan Hydrochloride)

Introduction to Hycamtin

Hycamtin, also known as topotecan hydrochloride, is a chemotherapeutic agent used primarily in the treatment of various cancers, including ovarian and small cell lung cancer. It functions as a topoisomerase I inhibitor, disrupting DNA replication and leading to cancer cell death.

Global Market Size and Growth

The global market for topotecan hydrochloride, including Hycamtin, is significant and growing. As of 2024, the global Topotecan Hydrochloride Sales Market size is estimated to be USD 572.6 million. This market is projected to expand at a compound annual growth rate (CAGR) of 5.00% from 2024 to 2031, reaching USD 805.70 million by 2031[1].

Market Drivers

Several factors drive the growth of the Hycamtin market:

Rising Cancer Prevalence

The increasing incidence of cancers, particularly ovarian and small cell lung cancer, is a major driver. As the global population ages and lifestyle factors contribute to higher cancer rates, the demand for effective treatments like Hycamtin increases[1][3].

Advancements in Drug Formulations

Advancements in drug formulations and the introduction of novel drug delivery systems enhance the efficacy and safety of Hycamtin, making it a preferred treatment option for certain cancer types[1].

Increased Investments in Oncology Research

Significant investments in oncology research and the development of targeted therapies further boost the market. The growing demand for personalized medicine and innovative treatment options drives the expansion of the Hycamtin market[1][3].

Regional Market Dynamics

North America

North America holds a major share of the global Topotecan Hydrochloride market, with a market size of USD 229.04 million in 2024. This region is expected to grow at a CAGR of 3.2% from 2024 to 2031[1].

Europe

Europe accounts for more than 30% of the global revenue, with a market size of USD 171.78 million in 2024. The European market is projected to grow at a CAGR of 3.5% from 2024 to 2031[1].

Asia-Pacific

The Asia-Pacific region is expected to expand at the fastest CAGR, driven by increasing cancer prevalence, improving healthcare infrastructure, and rising investments in medical research. This region held around 23% of the global revenue with a market size of USD 131.70 million in 2024 and is projected to grow at a CAGR of 7.0% from 2024 to 2031[1].

Latin America and Middle East & Africa

Latin America and the Middle East & Africa also contribute to the market growth, albeit at a slower pace. Latin America held around 5% of the global revenue with a market size of USD 28.63 million in 2024, growing at a CAGR of 4.4%. The Middle East & Africa held around 2% with a market size of USD 11.45 million in 2024, growing at a CAGR of 4.7% from 2024 to 2031[1].

Competitive Landscape

The oncology drugs market, including Hycamtin, is highly competitive with several key players:

• Hoffmann-La Roche Ltd.
• Genentech, Inc.
• Novartis AG
• Gilead Sciences Inc.
• AstraZeneca
• Pfizer Inc.
• Johnson & Johnson
• AbbVie
• Merck & Co.

These companies are involved in continuous research and development, new product launches, and strategic collaborations to maintain their market positions[3].

Financial Trajectory

Revenue Forecast

The revenue from Hycamtin is expected to increase significantly over the forecast period. With a projected CAGR of 5.00% from 2024 to 2031, the market is anticipated to reach USD 805.70 million by 2031[1].

Cost and Pricing

The cost of cancer medicines, including Hycamtin, is substantial, and managing stock bears significant financial risk. The pricing components and cost-effectiveness considerations are crucial for market dynamics. For instance, the Efficient Funding of Chemotherapy (EFC) program reviews and adjusts pricing and remuneration models to ensure efficient patient access to medicines[2].

Market Trends

Targeted Therapies

The adoption of targeted therapies and immunotherapies is a significant trend. Although chemotherapy, including drugs like Hycamtin, currently holds the largest share, targeted therapies are expected to grow rapidly and potentially surpass traditional chemotherapy by 2031[3].

Innovative Drug Delivery Systems

Advancements in drug delivery systems are enhancing the efficacy and reducing the side effects of oncology drugs. This innovation is a key driver for the growth of the Hycamtin market[1][3].

Geographical Expansion

The growing awareness of advanced cancer treatments and expanding access to healthcare facilities in emerging economies like China and India are accelerating market growth in the Asia-Pacific region[1].

Challenges and Opportunities

High Development Costs

High development costs and stringent government regulations are significant challenges for the oncology drugs market, including Hycamtin. However, these challenges also present opportunities for innovation and collaboration[3].

Genericization

The genericization of major drugs can slow down market growth. However, the introduction of novel drugs and formulations can mitigate this effect and provide new growth avenues[4].

Key Takeaways

• The global Topotecan Hydrochloride Sales Market, including Hycamtin, is projected to grow from USD 572.6 million in 2024 to USD 805.70 million by 2031.
• The market is driven by rising cancer prevalence, advancements in drug formulations, and increased investments in oncology research.
• Asia-Pacific is expected to be the fastest-growing region due to improving healthcare infrastructure and rising investments in medical research.
• The market faces challenges such as high development costs and stringent regulations but is also driven by innovations in targeted therapies and drug delivery systems.

FAQs

What is the current market size of Topotecan Hydrochloride?

The global Topotecan Hydrochloride Sales Market size is estimated to be USD 572.6 million in 2024[1].

What is the projected growth rate of the Topotecan Hydrochloride market?

The market is projected to expand at a CAGR of 5.00% from 2024 to 2031[1].

Which region is expected to grow the fastest in the Topotecan Hydrochloride market?

The Asia-Pacific region is expected to expand at the fastest CAGR due to increasing cancer prevalence and improving healthcare infrastructure[1].

What are the major drivers of the Hycamtin market?

The major drivers include rising cancer prevalence, advancements in drug formulations, and increased investments in oncology research[1][3].

Who are the key players in the oncology drugs market, including Hycamtin?

Key players include Hoffmann-La Roche Ltd., Genentech, Inc., Novartis AG, Gilead Sciences Inc., AstraZeneca, Pfizer Inc., Johnson & Johnson, AbbVie, and Merck & Co.[3].

Sources

1. Cognitive Market Research: Topotecan Hydrochloride Sales Market Report 2024 (Global Edition)
2. Consultation Hub: EFC Review Interim Report 2022
3. Coherent Market Insights: Oncology Drugs Market to Reach USD 532.91 Billion by 2031
4. MarketsandMarkets: Lung Cancer Therapeutics Market (NSCLC & SCLC) - 2010-2020