ANZEMET Drug Patent Profile

Which patents cover Anzemet, and what generic alternatives are available?

Anzemet is a drug marketed by Validus Pharms and is included in two NDAs.

The generic ingredient in ANZEMET is dolasetron mesylate. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the dolasetron mesylate profile page.

Summary for ANZEMET

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	101
Clinical Trials:	4
Patent Applications:	4,956
Drug Prices:	Drug price information for ANZEMET
What excipients (inactive ingredients) are in ANZEMET?	ANZEMET excipients list
DailyMed Link:	ANZEMET at DailyMed

See drug prices for ANZEMET

Recent Clinical Trials for ANZEMET

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

Sponsor	Phase
University of Pittsburgh	Phase 2
David A. Clump, MD, PhD	Phase 2
University of Southern California	N/A

See all ANZEMET clinical trials

Pharmacology for ANZEMET

Drug Class	Serotonin-3 Receptor Antagonist
Mechanism of Action	Serotonin 3 Receptor Antagonists

US Patents and Regulatory Information for ANZEMET

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Validus Pharms	ANZEMET	dolasetron mesylate	INJECTABLE;INJECTION	020624-002	Sep 11, 1997		DISCN	Yes	No
Validus Pharms	ANZEMET	dolasetron mesylate	TABLET;ORAL	020623-001	Sep 11, 1997		DISCN	Yes	No
Validus Pharms	ANZEMET	dolasetron mesylate	INJECTABLE;INJECTION	020624-001	Sep 11, 1997		DISCN	Yes	No
Validus Pharms	ANZEMET	dolasetron mesylate	INJECTABLE;INJECTION	020624-003	Dec 11, 2001		DISCN	No	No

Expired US Patents for ANZEMET

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Validus Pharms	ANZEMET	dolasetron mesylate	TABLET;ORAL	020623-001	Sep 11, 1997	4,906,755
Validus Pharms	ANZEMET	dolasetron mesylate	INJECTABLE;INJECTION	020624-002	Sep 11, 1997	4,906,755
Validus Pharms	ANZEMET	dolasetron mesylate	TABLET;ORAL	020623-002	Sep 11, 1997	4,906,775
Validus Pharms	ANZEMET	dolasetron mesylate	TABLET;ORAL	020623-002	Sep 11, 1997	4,906,755

International Patents for ANZEMET

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

Country	Patent Number	Title	Estimated Expiration
Germany	19775092
New Zealand	222349	HEXAHYDRO-8-HYDROXY-2,6-METHANO-2H-QUINOLIZINE-3(4H)-ONE COMPOUNDS, ESTERS THEREOF, AND PHARMACEUTICAL COMPOSITIONS CONTAINING SUCH
Norway	168106
Norway	891712

Supplementary Protection Certificates for ANZEMET

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0266730	73/1997	Austria		PRODUCT NAME: ANZEMET; NAT. REGISTRATION NO/DATE: 1-22014, 1-22015, 1-22016 19970624; FIRST REGISTRATION: GB PL 04425/0150 19960926
0266730	SPC/GB97/005	United Kingdom		PRODUCT NAME: DOLASETRON, OR A PHARMACEUTICALLY-ACCEPTABLE ACID ADDITION OR QUATERNARY AMMONIUM SALT THEREOF; REGISTERED: UK 04425/0150 19960926
0266730	C970043	Netherlands		PRODUCT NAME: DOLASETRON, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AAN- VAARDBAAR ZUURADDITIEZOUT, IN HET BIJZONDER HET MESYLAAT; NAT REGISTRATION NO/DATE: RVG 21707 - RVG 21709 19970623; FIRST REGISTRATION: GB PL 04425/0150, PL 04425/0152, PL 04425/0154 19960926
0266730	98C0014	Belgium		PRODUCT NAME: MIGLITOL; NAT. REGISTRATION NO/DATE: NL 22 138 19970204; FIRST REGISTRATION: NL - 19 343 UR 19960723

ANZEMET Market Analysis and Financial Projection Experimental

Antiemetics Drugs Market: Focus on ANZEMET

Market Overview of Antiemetics Drugs

The global antiemetics drugs market is a significant segment within the pharmaceutical industry, primarily focused on managing and preventing nausea and vomiting associated with various medical conditions and treatments. As of 2023, the market was valued at USD 7.49 billion and is projected to grow at a compound annual growth rate (CAGR) of 5.98% from 2024 to 2030, reaching USD 11.20 billion by 2030[1][3][4].

Key Drivers of the Antiemetics Drugs Market

Rising Incidences of Cancer and Gastroenteritis

The increasing prevalence of cancer and gastroenteritis are major drivers of the antiemetics drugs market. Cancer treatments, such as chemotherapy and radiation therapy, often induce nausea and vomiting, making antiemetic drugs essential for patient care[1][3][4].

Growing Research and Development Activities

Continuous research and development activities by pharmaceutical companies are introducing new and more effective antiemetic drugs. For instance, the approval of new drugs like Arokaris by Taiho Pharmaceutical Co., Ltd. in 2022 highlights the ongoing innovation in this sector[1].

Launch of Generic Substitutes

The surge in the launches of generic substitutes is another significant factor influencing market demand. The patent expiration of key antiemetic drugs opens opportunities for generic manufacturers, driving competition and affecting pricing and market share distribution among major pharmaceutical players[1][4].

Market Segmentation and ANZEMET

By Drug Type

The antiemetics drugs market is segmented by drug type, with serotonin-receptor antagonists holding the largest market share. This segment includes drugs like Ondansetron (Zofran), Dolasetron (Anzemet), and Granisetron (Kytril)[1][3].

ANZEMET (Dolasetron)

ANZEMET, or Dolasetron, is a serotonin-receptor antagonist used to prevent nausea and vomiting associated with chemotherapy and postoperative recovery. It is available in both injection and oral pill formulations.

• Market Share and Growth: The serotonin-receptor antagonists segment, which includes ANZEMET, accounted for approximately 29.71% of the market share in 2023 and is expected to witness the fastest growth during the forecast period[1].
• Clinical Use: ANZEMET is particularly effective in managing acute and delayed phases of chemotherapy-induced nausea and vomiting (CINV), making it a crucial drug in oncology care[3].

By Application

The chemotherapy segment dominates the application segment, with a market share of around 45.70% in 2023. ANZEMET, being a key drug in this segment, is widely used to manage CINV[1][3].

Regional Market Dynamics

North America

North America holds the largest market share, approximately 36.52% in 2023, due to the presence of key players like Pfizer and GSK plc, and the high prevalence of cancer in the region. The ongoing approvals for antiemetic drugs in North America further contribute to the regional growth[1][3][4].

Asia Pacific

The Asia Pacific region is expected to grow significantly, driven by the increasing incidences of cancer and gastroenteritis. For example, a study published by the National Library of Medicine projected a 12.8% increase in cancer cases in India from 2020 to 2025, which will drive the demand for antiemetic drugs like ANZEMET in this region[1][3].

Financial Trajectory

Revenue and Growth

The global antiemetics drugs market, including the segment for serotonin-receptor antagonists like ANZEMET, is expected to grow substantially. The market is projected to reach USD 11.20 billion by 2030, with a CAGR of 5.98% from 2024 to 2030[1].

Key Players and Market Competition

Companies such as Pfizer Inc., GSK plc, Astellas Pharma Inc., and Cipla Inc. are major players in the antiemetics drugs market. These companies are involved in continuous research and development, which includes the improvement and expansion of drugs like ANZEMET. The market competition is also influenced by the entry of generic manufacturers, which affects pricing and market share distribution[1][3][4].

Regulatory Factors

The approval process and regulatory requirements play a crucial role in the antiemetics drugs market. For instance, the FDA approval of BARHEMSYS in February 2020 for the prevention or treatment of postoperative nausea and vomiting highlights the stringent regulatory environment. These approvals and the patent expiration of key drugs can lead to market entry delays and increased costs for pharmaceutical companies but also open opportunities for generic manufacturers[3][4].

Key Takeaways

• The global antiemetics drugs market is driven by rising incidences of cancer and gastroenteritis, along with growing research and development activities.
• Serotonin-receptor antagonists, including ANZEMET, hold a significant market share and are expected to witness the fastest growth.
• North America dominates the market due to the presence of key players and high cancer prevalence.
• The Asia Pacific region is expected to grow significantly due to increasing cancer cases.
• Regulatory factors and the approval process influence market dynamics and competition.

FAQs

What is the current market size of the antiemetics drugs market?

The global antiemetics drugs market was valued at USD 7.49 billion in 2023[1].

Which segment holds the largest market share in the antiemetics drugs market?

The serotonin-receptor antagonists segment holds the largest market share, with drugs like Ondansetron, Dolasetron (ANZEMET), and Granisetron[1][3].

What are the key drivers of the antiemetics drugs market?

The key drivers include rising incidences of cancer and gastroenteritis, growing research and development activities, and the surge in the launches of generic substitutes[1][3][4].

Which region is expected to grow significantly in the antiemetics drugs market?

The Asia Pacific region is expected to grow significantly due to the increasing incidences of cancer and gastroenteritis[1][3].

What is the projected CAGR of the antiemetics drugs market from 2024 to 2030?

The market is expected to grow at a CAGR of 5.98% from 2024 to 2030[1].

Sources

1. Grand View Research: Antiemetics Drugs Market Size & Share Analysis Report 2030
2. Modivcare: Modivcare Reports First Quarter 2024 Financial Results
3. Vision Research Reports: Antiemetics Drugs Market Size, Growth, Trends, Report 2024-2033
4. GlobeNewswire: Global Antiemetics Drugs Market to Exhibit Growth at a CAGR of ~6% by 2030 | DelveInsight