MEPRON Drug Patent Profile

When do Mepron patents expire, and what generic alternatives are available?

Mepron is a drug marketed by Glaxosmithkline Llc and is included in two NDAs.

The generic ingredient in MEPRON is atovaquone. There are sixteen drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the atovaquone profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Mepron

A generic version of MEPRON was approved as atovaquone by AMNEAL PHARMS on March 18^th, 2014.

Summary for MEPRON

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	2
Patent Applications:	7,027
Drug Prices:	Drug price information for MEPRON
What excipients (inactive ingredients) are in MEPRON?	MEPRON excipients list
DailyMed Link:	MEPRON at DailyMed

See drug prices for MEPRON

Recent Clinical Trials for MEPRON

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

Sponsor	Phase
Texas Children's Hospital	Early Phase 1
Baylor College of Medicine	Early Phase 1
William Marsh Rice University	Early Phase 1

See all MEPRON clinical trials

Pharmacology for MEPRON

Drug Class

Antimalarial Antiprotozoal

Paragraph IV (Patent) Challenges for MEPRON

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
MEPRON	Oral Suspension	atovaquone	750 mg/5 mL	020500	1	2009-10-20

US Patents and Regulatory Information for MEPRON

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glaxosmithkline Llc	MEPRON	atovaquone	SUSPENSION;ORAL	020500-001	Feb 8, 1995	AB	RX	Yes	Yes
Glaxosmithkline Llc	MEPRON	atovaquone	TABLET;ORAL	020259-001	Nov 25, 1992		DISCN	Yes	No

Expired US Patents for MEPRON

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline Llc	MEPRON	atovaquone	SUSPENSION;ORAL	020500-001	Feb 8, 1995
Glaxosmithkline Llc	MEPRON	atovaquone	SUSPENSION;ORAL	020500-001	Feb 8, 1995
Glaxosmithkline Llc	MEPRON	atovaquone	TABLET;ORAL	020259-001	Nov 25, 1992
Glaxosmithkline Llc	MEPRON	atovaquone	TABLET;ORAL	020259-001	Nov 25, 1992

International Patents for MEPRON

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

Country	Patent Number	Title	Estimated Expiration
Japan	2804302
South Africa	8906227
China	1103290
Latvia	11273	Naphthoquinones for the treatment and prophylaxis of pneumocystis carinii infections

Supplementary Protection Certificates for MEPRON

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0123238	SPC/GB95/004	United Kingdom		PRODUCT NAME: ATOVAQUONE OPTIONALLY IN THE FORM OF A PHYSIOLOGICALLY ACCEPTABLE SALT; REGISTERED: LU 0458/94/08/0741 19940803; UK 0003/0337 19940823
0123238	95C0009	Belgium		PRODUCT NAME: ATOVAQUONUM; NATIONAL REGISTRTION NO/DATE: 251 IS 151 F 3 19950710; FIRST REGISTRATION: LU 0458/94/08/0741 19940803

Market Dynamics and Financial Trajectory for MEPRON

Last updated: February 20, 2026

What is MEPRON and its current market status?

MEPRON (generic name: mepolizumab) is a monoclonal antibody developed by GlaxoSmithKline (GSK). It targets interleukin-5 (IL-5) and is indicated for severe eosinophilic asthma and related conditions. Approved by the FDA in 2015, MEPRON is marketed under the brand name Nucala.

Its primary revenue driver remains asthma treatment, with recent expansion into eosinophilic granulomatosis with polyangiitis (EGPA). In 2022, GSK's global sales for Nucala reached approximately $1.8 billion, representing sustained growth driven by expanded indications and increasing adoption.

How does the competitive landscape influence MEPRON?

MEPRON faces competition mainly from:

• Fasenra (benralizumab) by AstraZeneca, approved since 2017 for eosinophilic asthma.
• Cinqair (reslizumab) by Teva, marketed since 2016 for severe asthma.
• Dupixent (dupilumab) by Sanofi/Regeneron, FDA-approved in 2018 for multiple asthma subtypes, including severe eosinophilic asthma.

Market share is fluid; MEPRON holds approximately 30-35% of the severe eosinophilic asthma biologics market, trailing behind Dupixent, which commands around 50% of the total biologic asthma segment.

What are the key drivers of revenue growth?

• Indication expansion: Approved for EGPA in 2021, broadening usage.
• Epidemiology: Approximately 5-10% of asthma patients have eosinophilic phenotype, totaling roughly 25 million globally, with unmet needs in treatment-refractory cases.
• Market penetration: Growing prescription trends in the US and Europe, driven by guideline updates encouraging biologic use.
• Pricing strategies: GSK prices Nucala at around $32,000 per year per patient, with pricing elasticity influenced by insurance coverage and rebate negotiations.

What are the risks impacting MEPRON’s financial trajectory?

• Competitive pressure: Dupixent's broader indication profile threatens market share.
• Pricing pressures: Payer pushback could result in price concessions.
• Regulatory hurdles: Potential delays in approvals for new indications may limit growth.
• Manufacturing challenges: Supply chain disruptions could affect availability, especially considering complex biologics manufacturing.

What future prospects exist for MEPRON?

• Pipeline developments: GSK is researching MEPRON's efficacy in nasal polyps and other eosinophilic conditions.
• Market growth: The global severe asthma biologics market is projected to expand at a CAGR of 10% from 2022-2030 [2], potentially increasing MEPRON’s sales.
• Regional expansion: Entry into emerging markets could augment revenue streams, contingent on pricing and reimbursement policies.

How do financial forecasts compare with competitors?

Drug	Approved Indications	2022 Revenue	Market Share (Severe Asthma)	Price per Treatment Year
MEPRON (Nucala)	Severe eosinophilic asthma, EGPA	$1.8 billion	30-35%	~$32,000
Fasenra	Severe eosinophilic asthma	~$1.2 billion	Comparable to MEPRON	Similar
Cinqair	Severe eosinophilic asthma	<$200 million	Under advanced competition	Similar
Dupixent	Multiple indications including asthma	$8.0 billion	Dominant in broader asthma	$35,000+

Key financial considerations

• Revenue growth rate: Estimated at 12-15% annually through 2025, driven by indication expansion and increased adoption.
• Margin profile: Gross margins around 70%, with R&D expenses representing approximately 15% of revenue.
• Impact of biosimilars: No biosimilar presence currently; patents extend until at least 2030.

Conclusion

MEPRON's market remains stable, with sustained revenue driven by expanding indications and increasing global adoption. Competitive pressures and payer negotiations pose potential risks. Its financial trajectory hinges on pipeline success, regional expansion, and evolving market dynamics.

Key Takeaways

• MEPRON generated $1.8 billion in 2022, with growth fueled by expanded indications.
• It holds a significant segment of the eosinophilic asthma biologics market but faces stiff competition from Dupixent and others.
• Revenue growth is expected to continue at a high single-digit to low double-digit rate until at least 2025.
• Patent protections and manufacturing stability underpin long-term revenue prospects.
• Market expansion into emerging regions and new indications remains critical for future growth.

FAQs

Q1: When are MEPRON's patent protections expected to expire?
Patents are valid until at least 2030, providing exclusivity during this period.

Q2: How does MEPRON's pricing compare to competitors?
Pricing bars at approximately $32,000 annually per patient, slightly below Dupixent but competitive within the biologic asthma segment.

Q3: What new indications could expand MEPRON’s market?
Potential approvals in nasal polyps, eosinophilic esophagitis, and other eosinophilic disorders are under investigation.

Q4: How significant is biosimilar entry risk?
Low at present; patents and complex manufacturing processes delay biosimilar entry until after 2030.

Q5: Which regions present the most growth opportunity?
Emerging markets like China, Latin America, and Southeast Asia, where biologic adoption is increasing, offer the most potential.

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References

[1] GSK. (2022). Nucala (mepolizumab) Sales Report.
[2] Grand View Research. (2022). Severe Asthma Treatment Market Size, Share & Trends.