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. Additional details are available on the dolasetron mesylate profile page.

Summary for ANZEMET

US Patents:	0
Applicants:	1
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	4
Patent Applications:	5,405
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

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
Validus Pharms	ANZEMET	dolasetron mesylate	TABLET;ORAL	020623-002	Sep 11, 1997		DISCN	Yes	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
Validus Pharms	ANZEMET	dolasetron mesylate	INJECTABLE;INJECTION	020624-003	Dec 11, 2001	4,906,755
Validus Pharms	ANZEMET	dolasetron mesylate	INJECTABLE;INJECTION	020624-001	Sep 11, 1997	4,906,775
Validus Pharms	ANZEMET	dolasetron mesylate	INJECTABLE;INJECTION	020624-001	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
Finland	91154
Spain	2080727
Germany	68924545
Denmark	171116
Mexico	9203134	ESTERES DE HEXAHIDRO-8-HIDROXI-2,6-METANO-2H-QUINOLIZIN-3-(4H)-ONA Y COMPUESTOS RELACIONADOS.
New Zealand	222349	HEXAHYDRO-8-HYDROXY-2,6-METHANO-2H-QUINOLIZINE-3(4H)-ONE COMPOUNDS, ESTERS THEREOF, AND PHARMACEUTICAL COMPOSITIONS CONTAINING SUCH
Hungary	T45055

Supplementary Protection Certificates for ANZEMET

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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	98C0014	Belgium		PRODUCT NAME: MIGLITOL; NAT. REGISTRATION NO/DATE: NL 22 138 19970204; FIRST REGISTRATION: NL - 19 343 UR 19960723
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

Market Dynamics and Financial Trajectory for ANZEMET

Last updated: July 30, 2025

Introduction

ANZEMET (dimenhydrinate) holds a prominent position in the global antiemetic market, primarily used to prevent and treat nausea, vomiting, and motion sickness. As a combination medication with established efficacy and safety, ANZEMET competes within a highly dynamic pharmaceutical landscape driven by evolving regulatory standards, demographic shifts, and emerging therapeutic alternatives. Analyzing the market dynamics and financial trajectory of ANZEMET offers crucial insights for manufacturers, investors, and healthcare stakeholders aiming to gauge long-term viability and positioning strategies.

Market Overview

Product Profile and Clinical Significance

ANZEMET combines diphenhydramine and chlorpromazine, delivering a potent antiemetic effect. It is primarily prescribed for postoperative nausea, chemotherapy-induced nausea, and motion sickness [1]. Its widespread utilization, rooted in its proven efficacy, has sustained steady demand.

Regulatory Environment

The regulatory landscape influences market expansion and product accessibility. ANZEMET's approval depends on regional agencies like FDA (U.S.), EMA (Europe), and equivalent bodies elsewhere. In some jurisdictions, the inclusion of generic versions or alternative therapies affects market share.

Competitive Landscape

The antiemetic market faces intensifying competition from newer agents such as 5-HT3 receptor antagonists (e.g., ondansetron) and NK1 receptor antagonists. While ANZEMET maintains popularity, generic competition exerts downward pressure on pricing and margins.

Geographical Market Distribution

North America and Europe constitute mature markets with high adoption levels. Emerging economies like China and India exhibit growth potential driven by increasing healthcare infrastructure, rising cancer prevalence, and patient awareness.

Market Dynamics

Drivers of Demand

1. Aging Population: Advanced age correlates with increased incidence of nausea-related conditions, amplifying demand for antiemetics [2].

2. Cancer Treatment Growth: Rising cancer prevalence worldwide fuels chemotherapy-associated nausea management [3].

3. Surgical Procedures: Increased surgical interventions, especially in developing regions, sustain need for postoperative antiemetic therapy [4].

4. Established Efficacy: ANZEMET's robust effectiveness and long-term clinical use bolster its continued prescription.

Challenges and Barriers

1. Generic Competition: Patent expirations and generic formulations threaten pricing power. Generics typically undercut branded options despite similar efficacy.

2. Regulatory Hurdles: Stringent approval processes for new formulations or combinations can delay market expansion.

3. Side Effect Profile: Antihistamines and phenothiazines can cause sedation, anticholinergic effects, limiting their use in sensitive populations and favoring newer agents with improved safety profiles.

4. Emerging Alternatives: Advances in targeted therapies and the development of newer antiemetics threaten market share.

Trends and Opportunities

• Formulation Innovations: Developing sustained-release or intravenous formulations could expand usage options.

• Combination Therapies: Pairing with other agents may improve efficacy and reduce adverse effects.

• Market Expansion: Growing healthcare infrastructure in emerging markets presents opportunities for increased penetration.

• Regulatory Resilience: Demonstrating safety and efficacy through ongoing clinical trials could sustain market confidence.

Financial Trajectory

Revenue Projections

ANZEMET's revenue trajectory is influenced by patent status, competitive pressures, and regional adoption. Historically, the drug has seen stable revenues in its core markets, with potential for growth in emerging economies.

• In Developed Markets: Revenue stability persists due to long-standing clinical use; however, growth is constrained by generic competition and the evolving antiemetic landscape.

• In Developing Markets: Entry or increased utilization amid expanding healthcare access offers upside, albeit challenged by pricing and regulatory hurdles.

Profitability Outlook

Margins are under pressure due to generic competition, leading to price erosion. Manufacturers focusing on cost management and formulations with differentiation can preserve margin levels.

Investment and R&D

Dedicated investment in R&D could explore new indications, formulations, or combination therapies, extending the product lifecycle and opening new revenue streams.

Market Impact of Patent Expiry

The patent expiration timeline significantly impacts financial projections. If the patent is nearing expiry, revenues could decline unless the company innovates or diversifies its portfolio.

Mergers, Acquisitions, and Alliances

Strategic collaborations can bolster market reach and introduce new formulations. Acquisitions of regional distributors or generic manufacturers can expand footprint and mitigate revenue decline.

Strategic Implications for Stakeholders

• Pharmaceutical Companies: Diversify pipelines with newer antiemetics; invest in formulation innovation and market expansion strategies.

• Investors: Monitor patent statuses, regulatory developments, and emerging competitors to assess long-term investment viability.

• Healthcare Providers: Consider the safety profiles and emerging alternatives when prescribing, balancing efficacy and patient-specific factors.

Key Takeaways

• Market stability is driven by ANZEMET's proven efficacy, but competition from generics and newer agents curtails revenue growth prospects.

• Emerging markets represent a significant opportunity for expansion, contingent on favorable regulatory environments and price strategies.

• Innovation and differentiation, such as new formulations or combination therapies, are essential for maintaining market share.

• Patent expiration timelines are critical; proactive strategies are necessary to mitigate revenue erosion.

• Regulatory developments and safety profiles influence adoption; ongoing clinical research can sustain relevance.

Conclusion

ANZEMET maintains a resilient position within the antiemetic market, propelled by clinical efficacy and widespread historical use. However, market dynamics—dominated by generic competition, demographic shifts, and evolving therapeutic options—necessitate strategic agility. Companies that invest in innovative formulations, expand into emerging markets, and adapt to regulatory landscapes can optimize the drug's financial trajectory. Long-term success hinges on proactive adaptation to these factors, ensuring ANZEMET remains a viable therapeutic option amid a rapidly evolving pharmaceutical environment.

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FAQs

Q1: How does patent expiry affect ANZEMET's market performance?
A1: Patent expiry typically leads to the entry of generic competitors, resulting in price reductions and decreased revenue margins for the original manufacturer. This necessitates strategies such as formulation innovation or market diversification to maintain profitability.

Q2: What are the main competitors to ANZEMET in the antiemetic market?
A2: Prominent competitors include 5-HT3 receptor antagonists like ondansetron, granisetron, and NK1 receptor antagonists like aprepitant, which often offer improved safety profiles and targeted efficacy.

Q3: Are there emerging therapeutic options that threaten ANZEMET's market share?
A3: Yes, newer antiemetics with fewer side effects and broader efficacy profiles are gaining popularity, especially in settings prioritizing patient safety and tolerability.

Q4: Which markets present the greatest growth opportunities for ANZEMET?
A4: Emerging markets such as China, India, and Southeast Asia offer significant growth due to expanding healthcare infrastructure, increasing cancer rates, and rising awareness of antiemetic therapies.

Q5: What strategies can manufacturers employ to extend ANZEMET’s market life?
A5: Strategies include developing new formulations, exploring combination therapies, pursuing new indications, entering emerging markets, and maintaining compliance with evolving regulatory standards.

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Sources:

[1] U.S. Food and Drug Administration. ANZEMET prescribing information.
[2] WHO Global Health Observatory. Aging populations and medication demand.
[3] International Agency for Research on Cancer. Rising global cancer incidence.
[4] OECD Health Data. Surgical procedures and associated medication use.