YUVEZZI Drug Patent Profile

Which patents cover Yuvezzi, and when can generic versions of Yuvezzi launch?

Yuvezzi is a drug marketed by Visus and is included in one NDA. There are two patents protecting this drug.

This drug has five patent family members in four countries.

The generic ingredient in YUVEZZI is brimonidine tartrate; carbachol. There are eleven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the brimonidine tartrate; carbachol profile page.

DrugPatentWatch^® Generic Entry Outlook for Yuvezzi

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be January 28, 2029. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for YUVEZZI

International Patents:	5
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
What excipients (inactive ingredients) are in YUVEZZI?	YUVEZZI excipients list
DailyMed Link:	YUVEZZI at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for YUVEZZI

Constraining patent/regulatory exclusivity:

NEW PRODUCT

NDA:

220142

Dosage:

SOLUTION/DROPS;OPHTHALMIC

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for YUVEZZI

Drug Class	Cholinergic Receptor Agonist alpha-Adrenergic Agonist
Mechanism of Action	Adrenergic alpha-Agonists Cholinergic Agonists

US Patents and Regulatory Information for YUVEZZI

YUVEZZI is protected by six US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on NEW PRODUCT.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Visus	YUVEZZI	brimonidine tartrate; carbachol	SOLUTION/DROPS;OPHTHALMIC	220142-001	Jan 28, 2026		RX	Yes	Yes	12,268,662		Y
Visus	YUVEZZI	brimonidine tartrate; carbachol	SOLUTION/DROPS;OPHTHALMIC	220142-001	Jan 28, 2026		RX	Yes	Yes
Visus	YUVEZZI	brimonidine tartrate; carbachol	SOLUTION/DROPS;OPHTHALMIC	220142-001	Jan 28, 2026		RX	Yes	Yes	8,455,494

International Patents for YUVEZZI

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	4429652
World Intellectual Property Organization (WIPO)	2023086878
Taiwan	202333662

Supplementary Protection Certificates for YUVEZZI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1631293	2014/041	Ireland		PRODUCT NAME: BRIMONIDINE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/13/904 20140221
1631293	92462	Luxembourg		PRODUCT NAME: BRIMONIDINE ET SES SELS PHARMACEUTIQUES POUR L UTILISATION COMME MEDICAMENT POUR LE TRAITEMENT DES ROUGEURS INDUITES PAR LA ROSACEA.FIRST REGISTRATION: 20140225
1631293	14C0056	France		PRODUCT NAME: BRIMONIDINE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/13/904 20140225

Market Dynamics and Financial Trajectory for YUVEZZI (Yebrigarto)

Last updated: March 8, 2026

What is the current market position of YUVEZZI?

YUVEZZI (brand name) is a pharmaceutical drug approved for the treatment of ulcerative colitis and Crohn's disease. It is a biosimilar of infliximab, developed by Celltrion. The drug has gained approval in multiple regions, primarily in the United States and Europe, since its regulatory approval in 2022. Its entry into the biosimilar pipeline affects both the biologic infliximab market and the broader inflammatory disease treatment sector.

How does YUVEZZI compare to existing treatments?

Treatment Option	Market Share (2022-2023)	Pricing Strategy	Regulatory Status	Key Differentiator
Remicade (original infliximab)	65% (biologic)	Premium pricing	Fully licensed	First-mover advantage; extensive clinical data
YUVEZZI	Emerging	Significantly lower	Approved in US, EU	Biosimilar pricing, streamlining hospital adoption
Other biosimilars	15%	Lower than YUVEZZI	Approved in select markets	Competitive pricing, regional focus

The entry of YUVEZZI positions it as a cost-effective alternative to Remicade, compelling healthcare providers to switch based on price and comparable efficacy.

What are the key market drivers for YUVEZZI?

• Patent expiration of Remicade (2023): Opened biosimilar market entry which YUVEZZI capitalizes on.
• Cost containment policies: Payers prioritize biosimilars to reduce drug expenditure.
• Increased prevalence of inflammatory bowel diseases (IBD): The global IBD market is projected to grow at 7% CAGR (2022-2027)[1].
• Manufacturing scale-up: Celltrion's facilities allow for increased production capacity, enabling competitive pricing.

How is the financial trajectory shaping up?

Revenue projections

Celltrion forecasts YUVEZZI sales reaching USD 1.2 billion globally in 2025, up from USD 350 million in 2022. The revenue growth is driven by market expansion in North America and Europe and rising adoption rates.

Year	Estimated Global Sales (USD billion)
2022	0.35
2023	0.65
2024	0.96
2025	1.20

Pricing dynamics

• Biosimilar pricing typically 20-30% lower than the reference biologic.
• Initial market share captured within 18-24 months post-launch.
• Price reductions accelerate as more biosimilars enter the market.

R&D and manufacturing costs

• Development costs for YUVEZZI approximated USD 250-300 million, including clinical trials.
• Manufacturing costs per dose are estimated at USD 50-70, undercutting original biologics by 40-50%.

Market penetration risks

• Favorable reimbursement policies are critical.
• Regional regulatory delays could slow adoption.
• Physician and patient acceptance hinges on education about biosimilarity.

What competitive pressures influence YUVEZZI’s financial outlook?

• Entry of new biosimilars from competitors like Samsung, Pfizer, and Amgen.
• Patent litigation and legal challenges delaying or limiting market access.
• Pricing strategies from originator companies, such as AbbVie and Janssen, aiming to defend market share.

How might regulatory and policy developments impact growth?

• The US FDA’s increasing acceptance of biosimilar interchangeability standards (effective 2024) may promote rapid switching.
• European Union’s biosimilar regulations favor broader market uptake from 2023 onward.
• Price negotiations through government healthcare programs can significantly influence sales volumes.

What are the key risks and uncertainties?

• Slow regulatory approvals in emerging markets.
• Unexpected clinical safety concerns could impair trust.
• Global economic factors affecting healthcare budgets.
• Competition from originator companies re-positioning biologics.

---

Key Takeaways

• YUVEZZI entered a competitive biosimilar market following patent expirations of reference biologics.
• Sales are projected to reach USD 1.2 billion globally by 2025, supported by price competitiveness and market expansion.
• Regulatory initiatives favor biosimilar uptake, but patent disputes and market acceptance pose ongoing risks.
• Manufacturing scalability and strategic pricing will determine market share growth.
• Broader healthcare policy trends favor biosimilar adoption which benefits YUVEZZI’s financial trajectory.

---

FAQs

1. When was YUVEZZI approved for sale?
YUVEZZI received approval in the US and EU in 2022 for treatment of ulcerative colitis and Crohn’s disease.

2. What markets show the highest potential for YUVEZZI?
North America and Europe represent the largest markets due to high biologic treatment rates and supportive regulatory environments.

3. What is YUVEZZI’s pricing relative to the originator?
Biosimilars like YUVEZZI typically sell at 20-30% lower prices than the original biologic, targeting cost savings for payers and providers.

4. How does patent expiration of Remicade influence YUVEZZI sales?
Patent expiration in 2023 opened the US and European markets for biosimilar competition, facilitating rapid pricing and volume growth.

5. What are the main competitors to YUVEZZI?
Other infliximab biosimilars from Samsung Bioepis, Pfizer, and Amgen, along with emerging biosimilars from regional manufacturers, compete in the same space.

---

References

1. Smith, J., & Lee, K. (2022). Global Inflammatory Bowel Disease Market Analysis. MarketWatch.