TOPOTECAN HYDROCHLORIDE - Generic Drug Details

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

Topotecan hydrochloride is the generic ingredient in three branded drugs marketed by Sandoz, Accord Hlthcare, Actavis Totowa, Dr Reddys Labs Ltd, Fresenius Kabi Usa, Meitheal, Novast Labs, Rising, Sagent Pharms, Sun Pharm Inds Ltd, Teyro Labs, Sandoz Inc, Dash Pharms, and Hospira Inc, and is included in eighteen NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Topotecan hydrochloride has eighteen patent family members in sixteen countries.

There are eight drug master file entries for topotecan hydrochloride. Seven suppliers are listed for this compound.

Summary for TOPOTECAN HYDROCHLORIDE

International Patents:	18
US Patents:	1
Tradenames:	3
Applicants:	14
NDAs:	18
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	7
Raw Ingredient (Bulk) Api Vendors:	108
Clinical Trials:	438
Patent Applications:	7,675
What excipients (inactive ingredients) are in TOPOTECAN HYDROCHLORIDE?	TOPOTECAN HYDROCHLORIDE excipients list
DailyMed Link:	TOPOTECAN HYDROCHLORIDE at DailyMed

Recent Clinical Trials for TOPOTECAN HYDROCHLORIDE

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

Sponsor	Phase
Verastem, Inc.	Phase 3
GOG Foundation	Phase 3
Luye Pharma Group Ltd.	Phase 3

See all TOPOTECAN HYDROCHLORIDE clinical trials

Pharmacology for TOPOTECAN HYDROCHLORIDE

Drug Class	Topoisomerase Inhibitor
Mechanism of Action	Topoisomerase Inhibitors

Medical Subject Heading (MeSH) Categories for TOPOTECAN HYDROCHLORIDE

Topoisomerase I Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for TOPOTECAN HYDROCHLORIDE

L01CE	Topoisomerase 1 (TOP1) inhibitors
L01C	PLANT ALKALOIDS AND OTHER NATURAL PRODUCTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for TOPOTECAN HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sandoz Inc	TOPOTECAN	topotecan hydrochloride	SOLUTION;INTRAVENOUS	200199-001	Feb 25, 2011		DISCN	Yes	No
Teyro Labs	TOPOTECAN HYDROCHLORIDE	topotecan hydrochloride	INJECTABLE;INJECTION	091199-001	Dec 1, 2010	AP	RX	No	No
Accord Hlthcare	TOPOTECAN HYDROCHLORIDE	topotecan hydrochloride	INJECTABLE;INJECTION	202351-001	Jun 26, 2013	AP	RX	No	No
Hospira Inc	TOPOTECAN HYDROCHLORIDE	topotecan hydrochloride	SOLUTION;INTRAVENOUS	200582-001	Feb 2, 2011	AP	RX	Yes	Yes
Sun Pharm Inds Ltd	TOPOTECAN HYDROCHLORIDE	topotecan hydrochloride	INJECTABLE;INJECTION	202203-001	Aug 29, 2013		DISCN	No	No

Expired US Patents for TOPOTECAN HYDROCHLORIDE

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 TOPOTECAN HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
Norway	20062616
Morocco	28179	NOUVEAU COMPOSE, COMPOSITIONS CORRESPONDANTES, METHODES DE FABRICATION ET/OU DE TRAITEMENT
Brazil	PI0416366	composto, composições correspondentes, métodos de preparação e/ou de tratamento
South Korea	20060122847	NOVEL COMPOUND, CORRESPONDING COMPOSITIONS, PREPARATION AND/OR TREATMENT METHODS
Taiwan	200530250	Novel compound, corresponding compositions, preparation and/or treatment methods

Supplementary Protection Certificates for TOPOTECAN HYDROCHLORIDE

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

TOPOTECAN HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Topotecan Hydrochloride

Introduction to Topotecan Hydrochloride

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

Global Market Size and Growth

The global Topotecan Hydrochloride Sales Market is projected to be USD 572.6 million in 2024. This market is expected to expand at a compound annual growth rate (CAGR) of 5.00% from 2024 to 2031, reaching USD 805.70 million by 2031[1].

Regional Market Breakdown

• North America: This region holds the largest share of the global market, with a market size of USD 229.04 million in 2024. It 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, and is expected to grow at a CAGR of 3.5% from 2024 to 2031[1].
• Asia Pacific: This region holds around 23% of the global revenue, with a market size of USD 131.70 million in 2024, and is expected to grow at a CAGR of 7.0% from 2024 to 2031[1].
• Latin America: The Latin American market accounts for more than 5% of the global revenue, with a market size of USD 28.63 million in 2024, and is expected to grow at a CAGR of 4.4% from 2024 to 2031[1].
• Middle East and Africa: This region holds around 2% of the global revenue, with a market size of USD 11.45 million in 2024, and is expected to grow at a CAGR of 4.7% from 2024 to 2031[1].

Drivers of Market Growth

Several factors are driving the growth of the topotecan hydrochloride market:

• Increasing Cancer Prevalence: The rising incidence of cancers such as ovarian and small cell lung cancer is a significant driver. As the global population ages and lifestyle factors contribute to higher cancer rates, the demand for effective treatments like topotecan hydrochloride increases[1].
• Advancements in Drug Formulations: Innovations in drug delivery systems, such as nanoencapsulation and targeted therapies, are enhancing the efficacy and safety of topotecan hydrochloride. For example, nanoformulations have shown improved cytotoxicity and better therapeutic outcomes[3].
• Investments in Oncology Research: Increased investments in oncology research are leading to better understanding and treatment of cancers, further boosting the market for topotecan hydrochloride[1].

Clinical Effectiveness and Cost-Effectiveness

Clinical trials and economic evaluations have assessed the effectiveness and cost-effectiveness of topotecan hydrochloride compared to other chemotherapy agents. For instance, a systematic review and economic evaluation found that for patients with platinum-sensitive ovarian cancer, paclitaxel plus platinum could be considered cost-effective compared to platinum alone. However, the cost-effectiveness of topotecan in certain scenarios, especially for platinum-resistant/refractory disease, is less clear and often not favorable[2].

Nanoenabled Delivery Systems

The use of nanoenabled active and passive targeting strategies is a significant trend in the delivery of topotecan hydrochloride. These systems leverage the enhanced permeability and retention (EPR) effect to accumulate at tumor sites, improving the drug's therapeutic efficacy and reducing side effects. Active targeting using specific ligands to over-expressed receptors on tumor cells further enhances the drug's delivery and effectiveness[3].

Combinatorial Drug Therapy

Combinatorial drug therapy employing topotecan hydrochloride is another area of research. Studies have shown that combining topotecan with other drugs can improve therapeutic outcomes. For example, combining topotecan with tamoxifen in polymeric nanoparticles has shown potential in preclinical studies[3].

Clinical Trials and Future Perspectives

Ongoing clinical trials are exploring new combinations and delivery methods for topotecan hydrochloride. For instance, a phase I trial is testing the safety and efficacy of tazemetostat in combination with topotecan and pembrolizumab in patients with small cell lung cancer[5].

Market Segmentation

The topotecan hydrochloride market is segmented based on type (Type I, Type II, Type III, Type IV) and application (injection, capsule), as well as geographical regions. This segmentation helps in understanding the specific needs and trends in different markets[4].

Key Players

Several companies are key players in the topotecan hydrochloride market, including Ark Pharm, Wilshire Technologies, ChemFaces, Boc Sciences, and CAYMAN CHEMICAL. These companies are involved in the production, research, and development of topotecan hydrochloride and its formulations[4].

Financial Projections

The financial trajectory of the topotecan hydrochloride market is positive, with steady growth projected over the next several years. The market's expansion is driven by increasing demand, advancements in technology, and ongoing research and development.

"The global Topotecan Hydrochloride Sales Market size will be USD 572.6 million in 2024 and will expand at a compound annual growth rate (CAGR) of 5.00% from 2024 to 2031, reaching USD 805.70 million by 2031"[1].

Challenges and Limitations

Despite the positive growth trajectory, there are challenges and limitations. The cost-effectiveness of topotecan hydrochloride in certain scenarios is a concern, and the comparative clinical effectiveness and cost-effectiveness of different chemotherapy regimens need further clarification through randomized controlled trials[2].

Key Takeaways

• The global topotecan hydrochloride market is expected to grow from USD 572.6 million in 2024 to USD 805.70 million by 2031.
• North America holds the largest market share, followed by Europe and Asia Pacific.
• Increasing cancer prevalence, advancements in drug formulations, and investments in oncology research are key drivers.
• Nanoenabled delivery systems and combinatorial drug therapies are enhancing the therapeutic efficacy of topotecan hydrochloride.
• Ongoing clinical trials are exploring new combinations and delivery methods.

FAQs

1. What is the primary use of topotecan hydrochloride?

Topotecan hydrochloride is primarily used in the treatment of various cancers, including ovarian and small cell lung cancer, by inhibiting topoisomerase I and disrupting DNA replication.

2. What is the projected global market size for topotecan hydrochloride in 2031?

The global topotecan hydrochloride market is expected to reach USD 805.70 million by 2031, growing at a CAGR of 5.00% from 2024 to 2031[1].

3. Which region holds the largest share of the topotecan hydrochloride market?

North America holds the largest share of the global topotecan hydrochloride market, with a market size of USD 229.04 million in 2024[1].

4. How are nanoenabled delivery systems improving the efficacy of topotecan hydrochloride?

Nanoenabled delivery systems, such as nanoencapsulation, leverage the enhanced permeability and retention (EPR) effect to accumulate at tumor sites, improving the drug's therapeutic efficacy and reducing side effects[3].

5. What are some of the key challenges in the topotecan hydrochloride market?

Challenges include the cost-effectiveness of topotecan hydrochloride in certain scenarios and the need for further clarification on the comparative clinical effectiveness and cost-effectiveness of different chemotherapy regimens through randomized controlled trials[2].

Cited Sources:

1. Cognitive Market Research, "Topotecan Hydrochloride Sales Market Report 2024 (Global Edition)".
2. PubMed, "A systematic review and economic evaluation".
3. MDPI, "Nanoplatform for the Delivery of Topotecan in the Cancer Milieu".
4. Market Research Intellect, "Global Topotecan Hydrochloride Market Size And Forecast".
5. National Cancer Institute, "Clinical Trials Using Topotecan Hydrochloride".