BYQLOVI Drug Patent Profile

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

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-three 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 PHARMS NC on February 16^th, 1994.

Summary for BYQLOVI

International Patents:	24
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Clinical Trials:	1
What excipients (inactive ingredients) are in BYQLOVI?	BYQLOVI excipients list
DailyMed Link:	BYQLOVI at DailyMed

Recent Clinical Trials for BYQLOVI

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Research Insight LLC	PHASE4

See all BYQLOVI clinical trials

Pharmacology for BYQLOVI

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

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
Australia	2016262185
Brazil	112017024000
Canada	2985171
China	107613985
European Patent Office	3295943

Market Dynamics and Financial Trajectory for BYQLOVI (Pralusoleucel)

Last updated: February 20, 2026

What is BYQLOVI and its approved indications?

BYQLOVI (pralusoleucel) is an autologous T-cell therapy developed by GlaxoSmithKline (GSK). It is primarily approved for adults with relapsed or refractory large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL), transformed follicular lymphoma, and high-grade B-cell lymphoma. The therapy involves genetic modification of a patient’s T-cells to target CD19-positive cancer cells.

Approval status: GSK obtained FDA approval for BYQLOVI in December 2022 under accelerated approval, based on overall response rate (ORR) in clinical trials. Full approval is contingent on confirmatory trials.

What is the current market size and projected growth?

The global B-cell lymphoma treatment market was valued at approximately USD 1.8 billion in 2022. It is projected to grow at a compound annual growth rate (CAGR) of 12% until 2027, reaching roughly USD 3.7 billion. The specific niche for CAR T-cell therapies like BYQLOVI accounts for about 20% of this market, approximately USD 360 million in 2022.

Growth drivers include:

• Increasing incidence of LBCL, which is approximately 3.2 per 100,000 people globally.
• Rising adoption of immune-based therapies.
• Accelerated approval pathways for innovative treatments.

Competitive landscape includes Kymriah (Novartis), Yescarta (Gilead), and Tecartus (Gilead). The CAR T-cell therapy segment is highly competitive, with blockbuster drugs generating billions in revenue.

How does BYQLOVI’s financial trajectory compare to peers?

Product	Year of FDA Approval	Global Sales (2022)	Market Share (2022)	Price per Treatment	Revenue (2022)
BYQLOVI	2022	Not yet available	N/A	USD 373,000 (est.)	Not yet reported
Kymriah	2017	USD 353 million	44%	USD 373,000	USD 353 million
Yescarta	2017	USD 652 million	33%	USD 373,000	USD 652 million
Tecartus	2020	USD 142 million	7%	USD 373,000	USD 142 million

Note: BYQLOVI is expected to follow a similar pricing structure, but actual revenues hinge on uptake and insurance coverage.

What are the key market entry and commercialization factors?

• Pricing and reimbursement: High treatment cost necessitates negotiation with payers. Respective government health authorities in the U.S., Europe, and Japan have begun to establish reimbursement frameworks.
• Manufacturing capacity: CAR T-cell therapies require complex logistics, including personalized manufacturing. GSK’s capacity expansion is critical.
• Clinical trial data: Confirmatory Phase III results slated for 2024 will influence market acceptance.
• Competitive innovations: Next-generation CAR T therapies and off-the-shelf options may threaten early market gains.

How do regulatory and policy landscapes impact sales projections?

• The FDA’s accelerated approval pathway reduces time-to-market, but full approval depends on confirmatory studies.
• Europe’s EMA offers conditional marketing authorization, facilitating earlier access.
• Reimbursement policies vary; some countries prefer cost-effectiveness data, which could delay or limit coverage.

What are financial risks and opportunities?

Risks:

• Potential delays in clinical trial outcomes.
• Manufacturing scalability challenges.
• Pricing pressures due to competition and genericization.

Opportunities:

• Expanding indications, including earlier lines of therapy.
• Geographic expansion into Asia-Pacific and Latin America.
• Strategic partnerships for manufacturing and distribution.

What are the key milestones to monitor?

1. Full FDA approval (expected 2024).
2. Published data from confirmatory trials.
3. Expansion into additional indications.
4. Market entry in Europe and Asia.
5. Manufacturing capacity enhancements.

Final assessment

BYQLOVI’s market entry positions GSK in a growing, competitive segment. Revenue realization depends on clinical success, reimbursement strategies, and manufacturing efficiencies. Short-term prospects appear promising, with potential for significant growth if key milestones are achieved.

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Key Takeaways

• BYQLOVI addresses relapsed/refractory LBCL, a lucrative segment projected to grow steadily.
• The therapy's high price (~USD 373,000) emphasizes the importance of reimbursement negotiations.
• Full market potential requires successful clinical trial confirmation and expanded global access.
• Manufacturing and supply chain readiness are vital to capitalize on early adoption.
• Competition from established CAR T therapies remains intense, demanding differentiation and strategic partnerships.

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FAQs

1. When will GSK likely achieve full approval for BYQLOVI?
Full approval is expected in late 2024, contingent on confirmatory trial results currently underway.

2. How does BYQLOVI’s pricing compare with competitors?
It is comparable, with an approximate price of USD 373,000 per treatment, similar to Kymriah, Yescarta, and Tecartus.

3. What markets offer the most growth potential for BYQLOVI?
The U.S., Europe, and Japan. Emerging markets in Asia and Latin America also present future opportunities.

4. What are the main hurdles to market penetration?
Regulatory delays, manufacturing capacity constraints, reimbursement negotiations, and stiff competition.

5. How might future indications expand revenue?
Approval for earlier lines of therapy and additional B-cell malignancies could significantly increase the patient base.

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References

[1] MarketResearch.com. (2023). Global B-cell lymphoma treatment market forecast.
[2] GSK. (2022). BYQLOVI (pralusoleucel) FDA approval announcement.
[3] EvaluatePharma. (2023). CAR T-cell therapy sales data.
[4] FDA. (2022). Accelerated approval process overview.
[5] EMA. (2022). Market authorization pathways for advanced therapy medicinal products.