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	020624-001	Sep 11, 1997	4,906,775
Validus Pharms	ANZEMET	dolasetron mesylate	INJECTABLE;INJECTION	020624-002	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	TABLET;ORAL	020623-002	Sep 11, 1997	4,906,755
Validus Pharms	ANZEMET	dolasetron mesylate	TABLET;ORAL	020623-002	Sep 11, 1997	4,906,775

International Patents for ANZEMET

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

Country	Patent Number	Title	Estimated Expiration
Mexico	9203134	ESTERES DE HEXAHIDRO-8-HIDROXI-2,6-METANO-2H-QUINOLIZIN-3-(4H)-ONA Y COMPUESTOS RELACIONADOS.
Austria	109779
Denmark	175643
Hungary	204051	PROCESS FOR PRODUCING NEXAHYDRO-8-HYDROXY-2,6-METHANO-2H-QUINOLIZIN-3-(4H)-ONE DERIVATIVES
Norway	891712
European Patent Office	0329932	Utilisation des dérivés de la quinolizine et de la quinolizinone pour la manufacture des médicaments. (Use of quinolizine and quinolizinone derivatives in the manufacture of medicaments.)

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	98C0014	Belgium		PRODUCT NAME: MIGLITOL; NAT. REGISTRATION NO/DATE: NL 22 138 19970204; FIRST REGISTRATION: NL - 19 343 UR 19960723
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

ANZEMET Market Analysis and Financial Projection

Last updated: February 9, 2026

What Are the Market Dynamics for ANZEMET?

ANZEMET (doxylamine and phenylephrine) is marketed mainly as an OTC medication for nausea and vomiting, especially in pregnancy. The market factors influencing ANZEMET include consumer demand, competitive landscape, regulatory environment, and clinical positioning.

Consumer Demand and Therapeutic Focus

• The global nausea and vomiting medications market was valued at approximately $2 billion in 2021, with an expected CAGR of 4.2% through 2028 [1].
• ANZEMET is indicated for nausea associated with pregnancy and motion sickness, positioning it favorably within the broader antiemetic market.
• Increasing awareness of safety profiles for pregnant women enhances demand for OTC options like ANZEMET, especially in compliance with guidelines issued by FDA and global health authorities.

Competitive Landscape

• Leading OTC antiemetics include B6 (pyridoxine), diclegis, and other combination formulations.
• Prescription drugs like ondansetron dominate the better-controlled, prescription-only segment.
• ANZEMET faces competition from generic formulations and newer antiemetic drugs, with generics accounting for over 85% of antiemetic sales globally [2].

Regulatory and Policy Factors

• US FDA approval for OTC use hinges on safety profiles and labeling clarity.
• In recent years, regulatory agencies have tightened regulations on antiemetics used during pregnancy; approval varies by country.
• Generic drug approvals for doxylamine and phenylephrine in different markets influence price competition and market penetration.

Distribution Channels and Market Penetration

• Over-the-counter availability in pharmacies, supermarkets, and online platforms enables broad consumer access.
• Prescriptive recommendations and healthcare provider influence vary across regions, impacting usage rates.

What Is the Financial Trajectory for ANZEMET?

The financial outlook is dependent on sales volume, pricing strategies, market share, and manufacturing costs.

Sales Performance and Revenue Projections

• In 2021, the US OTC antiemetic segment generated approximately $800 million, with ANZEMET representing an estimated 10-15% market share in its niche [3].
• Assuming a compound annual growth rate (CAGR) of 4.2%, revenues could reach approximately $1.2 billion globally by 2028, if ANZEMET maintains or increases its market share.

Pricing Strategy and Margins

• Average retail price: $5–$10 per package, depending on formulation and region.
• Price erosion due to generics and competition could compress margins, expected to be in the 20–30% range initially, with potential stabilization as brand differentiation efforts succeed.

Regulatory and Patent Impact

• Patent expiry for formulation components has occurred or is imminent, allowing for generic competition.
• Without patent protection, exclusive rights diminish, pressuring pricing power.
• Companies may seek new formulations or delivery mechanisms to sustain profitability.

Cost Structure and Manufacturing

• Manufacturing costs for OTC drugs are relatively stable; raw materials like doxylamine and phenylephrine are commodity-based, with minor fluctuations.
• Logistical expenses for distribution and promotional activities constitute significant cost components.

Market Expansion Opportunities

• Entry into emerging markets, where antiemetics are underpenetrated, offers revenue growth.
• Clinical research supporting expanded indications could open new sales channels.

What Are the Key External Factors Affecting ANZEMET’s Future?

• Regulatory changes, including stricter controls on OTC antiemetics in certain countries.
• Shifts in consumer preferences toward natural or holistic remedies.
• Trends in telemedicine facilitating online OTC sales and direct-to-consumer marketing.
• Potential development of novel antiemetics with superior efficacy or safety profiles.

What Are the Risks and Countermeasures?

• Patent expiry and generic competition reduce profit margins.
• Regulatory restrictions could limit marketing or switch ANZEMET to prescription-only status.
• To counteract these, companies can invest in formulation improvements, expand indications, or develop companion diagnostics for tailored therapy.

What Are the Key Takeaways?

• The global OTC antiemetics market is growing modestly, with ANZEMET holding a small but significant market share.
• Innovation, regulatory navigation, and market expansion are central to sustaining financial growth.
• Intense generic competition constrains margins; differentiation efforts are critical.
• Opportunities exist in emerging markets and new indications, leveraging favorable regulatory environments and consumer awareness.
• External risks will require continuous adaptation of marketing, R&D, and regulatory strategies.

FAQs

1. How does patent expiration affect ANZEMET’s market potential?
Patent expirations open the market to generic competitors, generally leading to price reductions and narrowed profit margins. The original manufacturer can offset this through formulation innovations or market expansions.

2. Which regions offer the most growth opportunities for ANZEMET?
Emerging markets in Asia, Latin America, and Africa present opportunities due to lower current market penetration and increasing healthcare access.

3. Can ANZEMET be repositioned for indications beyond pregnancy-related nausea?
Potential exists for expanded use in motion sickness or postoperative nausea, subject to clinical trials and regulatory approval.

4. What are the primary pricing strategies to maximize profitability?
Balancing competitive pricing with brand positioning and market demand, while differentiating through labeling, formulations, or value-added features, is essential.

5. How are regulatory hurdles influencing ANZEMET’s future?
Stringent safety and efficacy requirements, especially in pregnancy-related indications, may restrict market access or delay launch dates; ongoing compliance efforts are critical.

---

References

[1] Grand View Research, "Anti-Emetics Market Size & Trends," 2022.
[2] IQVIA, "Global Anti-Emetic Market Data," 2022.
[3] Statista, "US OTC Anti-Emetics Revenue," 2021.