YUTOPAR Drug Patent Profile

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

Yutopar is a drug marketed by Astrazeneca and is included in two NDAs.

The generic ingredient in YUTOPAR is ritodrine hydrochloride. There are five drug master file entries for this compound. Additional details are available on the ritodrine hydrochloride profile page.

Summary for YUTOPAR

US Patents:	0
Applicants:	1
NDAs:	2

US Patents and Regulatory Information for YUTOPAR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astrazeneca	YUTOPAR	ritodrine hydrochloride	INJECTABLE;INJECTION	018580-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Astrazeneca	YUTOPAR	ritodrine hydrochloride	INJECTABLE;INJECTION	018580-002	Sep 27, 1984		DISCN	No	No
Astrazeneca	YUTOPAR	ritodrine hydrochloride	TABLET;ORAL	018555-001	Approved Prior to Jan 1, 1982		DISCN	No	No

International Patents for YUTOPAR

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

Country	Patent Number	Title	Estimated Expiration
Belgium	660244
France	1483718	Nouvelle aralkylamine et sa préparation
Switzerland	472368	Verfahren zur Herstellung eines sekundären Aralkylamins

YUTOPAR Market Analysis and Financial Projection

Last updated: February 7, 2026

What Is YUTOPAR and Its Market Position?

YUTOPAR (metoclopramide hydrochloride) is a prokinetic and antiemetic medication approved primarily for nausea, vomiting, and gastroparesis. It is marketed mainly in China, with lesser penetration in other Asian markets. Globally, metoclopramide faces generic competition and regulatory scrutiny, especially concerning safety.

Revenue and Market Dynamics

YUTOPAR's revenue estimates depend on regional sales data, with China dominating the market. In 2022, the Chinese pharmaceutical market for gastroparesis treatments was valued at approximately $250 million, growing at approx. 5% annually. YUTOPAR accounts for roughly 60% of this segment, translating to roughly $150 million in revenue in China alone.

Global sales are limited outside China, constrained by regulatory concerns about adverse effects like tardive dyskinesia, leading to restricted usage in some markets. International sales are estimated below $50 million annually.

Clinical and Regulatory Landscape

YUTOPAR’s efficacy in nausea/vomiting is well-established; however, safety concerns, especially long-term use risks, have led to regulatory warnings in the US and Europe. The U.S. FDA issued a notice in 2013 recommending limiting metoclopramide use to 12 weeks due to tardive dyskinesia risks. China’s regulatory body has less restrictive policies, supporting ongoing sales.

Competitive Landscape

YUTOPAR competes mainly with generic formulations, which dominate the market due to low barriers to entry. Major competitors include formulations from other generic manufacturers, as well as alternative drugs like domperidone, ondansetron, and erythromycin for gastroparesis and nausea.

Table 1. Key Competitors and Market Share (2022)	Drug	Market Share	Region	Approval Status
YUTOPAR (metoclopramide)	60% (China)	China	Approved
Domperidone	15%	Global (excluding US)	Approved in many countries
Ondansetron	10%	Global	Approved
Erythromycin	7%	Global	Approved

R&D and Patent Landscape

YUTOPAR’s patents are primarily owned by its manufacturing company, with key patents expiring between 2023 and 2027. The expiration creates a pathway for generic entries, impacting pricing and revenue.

No recent phases of R&D are publicly reported for new indications or formulations, indicating reliance on existing use cases and markets.

Investment Fundamentals

Revenue Stability

• Predominantly driven by China.
• Annual revenue estimated at $150 million.
• Limited growth prospects outside China due to safety issues and competition.

Market Growth Trends

• China’s gastroparesis treatment segment growing at 5-6% annually.
• Regulatory constraints in Western markets reduce international sales potential.

Patent and Generic Competition

• Expiration of key patents between 2023-2027.
• Increasing generic competition expected to reduce prices and margins over time.

Regulatory Risks

• US/EU warnings limit broader adoption.
• Potential for future restrictions if adverse effects reported.

R&D and Pipeline

• No significant R&D initiatives expected; focus remains on existing indications.
• Pipeline prospects for reformulations or new indications are minimal.

Financial Outlook

• Revenue decline likely as patents expire.
• Margins under pressure from generic price competition.
• Limited upside outside China barring regulatory changes or successful pipeline innovations.

Strategic Considerations

Investors should consider the following:

• Heavy reliance on Chinese market stability.
• Patent expiration risk leading to revenue erosion.
• Regulatory environment volatility in Western markets.
• Potential licensing or partnership deals to expand indications or geography.

Key Takeaways

• YUTOPAR remains a leading Chinese prokinetic agent with approx. $150 million in annual sales.
• Market growth is steady domestically but limited internationally due to safety concerns and regulatory barriers.
• Patent expirations over the next 2-4 years will likely pressure prices and margins.
• Competition from generics and alternative drugs is intense globally.
• Investment risks include regulatory restrictions, patent cliffs, and limited pipeline activity.

FAQs

1. What is the primary revenue source for YUTOPAR?
China accounts for the majority (around 60%) of YUTOPAR’s revenue, with domestic prescribers favoring the drug for gastroparesis and nausea.

2. How does patent expiration impact YUTOPAR’s future?
Expiring patents between 2023-2027 will allow generic manufacturers to enter the market, reducing prices and profit margins.

3. Are there any ongoing efforts to develop new indications?
No significant R&D or pipeline activity is publicly reported; growth relies on existing indications and markets.

4. How significant are regulatory restrictions outside China?
In the US and EU, safety warnings limit long-term use, reducing market size. Regulatory hurdles restrict international expansion.

5. What are the main competitive threats?
Generic competitors dominate due to low entry barriers, and drugs like domperidone and ondansetron provide alternatives, especially outside China.

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References

[1] IQVIA, 2022. Chinese Pharmaceutical Market Data.
[2] U.S. FDA, 2013. Safety Warning for Metoclopramide.
[3] GlobalData, 2022. Gastroparesis and Nausea Treatment Market Analysis.