BYQLOVI Drug Patent Profile

When do Byqlovi patents expire, and when can generic versions of Byqlovi launch?

Byqlovi is a drug marketed by Harrow Eye and is included in one NDA. There are two patents protecting this drug.

This drug has twenty-four patent family members in seventeen countries.

The generic ingredient in BYQLOVI is clobetasol propionate. There are fourteen drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the clobetasol propionate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Byqlovi

A generic version of BYQLOVI was approved as clobetasol propionate by COSETTE on February 16^th, 1994.

Summary for BYQLOVI

International Patents:	24
US Patents:	2
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for BYQLOVI

BYQLOVI is protected by two US patents and one FDA Regulatory Exclusivity.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Harrow Eye	BYQLOVI	clobetasol propionate	SUSPENSION/DROPS;OPHTHALMIC	218158-001	Mar 4, 2024		RX	Yes	Yes	11,376,262		Y
Harrow Eye	BYQLOVI	clobetasol propionate	SUSPENSION/DROPS;OPHTHALMIC	218158-001	Mar 4, 2024		RX	Yes	Yes	10,588,913		Y
Harrow Eye	BYQLOVI	clobetasol propionate	SUSPENSION/DROPS;OPHTHALMIC	218158-001	Mar 4, 2024		RX	Yes	Yes

International Patents for BYQLOVI

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

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2016181935
Finland	3295943
Poland	3295943
South Korea	20210076202	글루코코르티코스테로이드의 나노미립자를 함유하는 수성 현탁액제 (AQUEOUS SUSPENSION COMPRISING NANOPARTICLES OF A GLUCOCORTICOSTEROID COMPOUND)
World Intellectual Property Organization (WIPO)	2016181935

Investment Scenario and Fundamentals Analysis for BYQLOVI (Lookalike: Bupropion)

Last updated: February 20, 2026

What is BYQLOVI?

BYQLOVI is a generic or biosimilar version of bupropion, a well-established antidepressant and smoking cessation aid. Bupropion is marketed under brand names like Wellbutrin and Zyban. Its key indications include major depressive disorder, seasonal affective disorder, and smoking cessation.

Market Overview

• Global antidepressant market size (2022): $17.8 billion.
• Expected CAGR (2023-2030): 4.6%.
• Major competitors: Eli Lilly (Wellbutrin), GlaxoSmithKline (Zyban), Apotex, Teva, Mylan, etc.
• Patent status: Expired in many jurisdictions; recent entries include generics and biosimilars.

Investment Considerations

1. Patent and Regulatory Status

• Patent expiration: Indicates potential for generic market entry.
• Regulatory approval: Approval in target markets (US, EU, emerging markets) is essential.
• Biosimilar vs. generic: Bupropion is a small molecule, compelling for generic market strategies.

2. Market Penetration and Pricing

• Pricing pressure: Entry of generics reduces prices by 50% or more.
• Market share: Existing brand loyalty favors incumbent products.
• Reimbursement policies: Favorability varies; insurance coverage influences sales.

3. Competitive Landscape

• Existing generics: Multiple players, intense price competition.
• Differentiation: Minimal; primarily based on pricing and supply chain.

4. Manufacturing and Supply Chain

• Manufacturing complexity: Low, as bupropion is a small molecule.
• Regulatory hurdles: Slight, mainly quality and bioequivalence documentation.
• Supply chain stability: Critical for maintaining market share.

5. R&D and Go-to-Market Strategy

• Development costs: Relatively low for generics.
• Time to market: Approximately 1-2 years after approval, depending on jurisdictions.
• Market entry barriers: Patent challenges, regulatory approvals, and distribution channels.

Financial Projections

Parameter	Historical/Benchmark Data	Implication for BYQLOVI
Average generic price decline	50-60% after patent expiry	Significant reduction in revenue per unit
Penetration rate (Year 1)	20-30% in established markets	Moderate initial market share
Breakeven point	2-3 years post-launch	Short timelines due to low R&D costs
Market share potential (5 years)	10-25% of total bupropion sales	Depends on execution, supply chain

Risks and Mitigation

• Pricing erosion: Continuous differentiation and cost management.
• Regulatory delays: Early engagement and robust submission documentation.
• Market entry barriers: Strategic partnerships with distributors and payers.

Investment Outlook

Potential exists in rapid market entry through cost-effective manufacturing and aggressive pricing. However, barriers include market saturation and limited differentiation. The low R&D investment and short time-to-market favor quick revenue realization, but fierce generic competition limits long-term pricing power.

Key Takeaways

• BYQLOVI enters a mature, saturated market with predictable revenue streams.
• Actual market share depends on effective regulatory and distribution strategies.
• Margins are compressed due to pricing competition; volume becomes critical.
• Fast time-to-market provides early revenue but faces stiff competition.
• Brand loyalty favors incumbent players; generics can capture share through price.

FAQs

1. What are the main regulatory hurdles for BYQLOVI?
Approval typically requires demonstrating bioequivalence with the brand-name drug in target jurisdictions, moderate in time and cost compared to innovative drugs.

2. How does patent expiry influence the market for BYQLOVI?
Patent expiry in key markets opens the door for generic competitors, increasing market access but leading to price competition.

3. What are the primary sources of revenue for generic bupropion products?
Volume sales driven by price competitiveness, supply chain reliability, and reimbursement coverage.

4. How does market saturation affect BYQLOVI’s profit potential?
High saturation limits pricing flexibility; profit mostly depends on achieving market share efficiently.

5. What strategic moves could enhance BYQLOVI’s market position?
Securing cost-effective manufacturing, engaging early with regulators, and building supply partnerships.

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References

[1] MarketsandMarkets. (2022). Antidepressant drugs market size, outlook, and growth projections.
[2] U.S. Food and Drug Administration. (2021). Bioequivalence guideline for small molecules.
[3] IQVIA. (2022). Global generic drug sales and market shares report.
[4] GlobalData. (2023). Competitive landscape analysis for antidepressants.
[5] IMS Health. (2022). Reimbursement policies impacting antidepressant market.