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:	121
Clinical Trials:	2
Patent Applications:	5,133
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
William Marsh Rice University	Early Phase 1
Texas Children's Hospital	Early Phase 1
Baylor College of Medicine	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	TABLET;ORAL	020259-001	Nov 25, 1992
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	SUSPENSION;ORAL	020500-001	Feb 8, 1995
Glaxosmithkline Llc	MEPRON	atovaquone	SUSPENSION;ORAL	020500-001	Feb 8, 1995

International Patents for MEPRON

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

Country	Patent Number	Title	Estimated Expiration
Poland	309629
Denmark	175868
Denmark	0675711
Bulgaria	61932
United Kingdom	8310141

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

MEPRON Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for MEPRON (Atovaquone)

Introduction

MEPRON, also known as atovaquone, is a quinone antimicrobial drug used primarily for the prevention and treatment of Pneumocystis jirovecii pneumonia (PCP) in patients who cannot tolerate trimethoprim-sulfamethoxazole (TMP-SMX). Here, we will delve into the market dynamics and financial trajectory of MEPRON.

Market Indications and Usage

MEPRON is indicated for the prevention and treatment of mild-to-moderate PCP in adults and adolescents aged 13 years and older who are intolerant to TMP-SMX. This specific indication positions MEPRON as a critical alternative in the antimicrobial market, particularly for patients with HIV/AIDS or other immunocompromised conditions[4].

Competitive Landscape

The market for PCP treatment is relatively niche but crucial for certain patient populations. MEPRON competes primarily with TMP-SMX, which is the first-line treatment for PCP but can have significant adverse effects, leading to a need for alternatives. In clinical trials, MEPRON has shown a lower rate of adverse reactions compared to TMP-SMX, which can be a significant competitive advantage[1][4].

Pricing and Cost

The cost of MEPRON is substantial, reflecting its specialized use and the complexity of its production. A 210-milliliter supply of MEPRON oral suspension, which contains 750 mg of atovaquone per 5 mL, can cost around $1,476 for cash-paying customers. However, generic versions of atovaquone are available at lower prices, starting from around $193.65 for 90 milliliters[2].

Patient Assistance and Discounts

To make MEPRON more accessible, various patient assistance programs and discount cards are available. For instance, the Drugs.com Discount Card can save patients up to 80% on the cost of MEPRON and other prescription medicines. These programs help mitigate the financial burden on patients who require this medication[2].

Clinical Trials and Efficacy

Clinical trials have demonstrated that MEPRON is effective in treating and preventing PCP, with a therapy success rate comparable to TMP-SMX. However, MEPRON has a better safety profile, with fewer patients discontinuing treatment due to adverse reactions. This efficacy and safety data support its market position as a viable alternative to TMP-SMX[1][4].

Adverse Reactions and Safety Profile

While MEPRON has a generally favorable safety profile, it is not without adverse reactions. Common adverse reactions include rash, nausea, diarrhea, and vomiting. However, these reactions are less frequent and severe compared to those associated with TMP-SMX. The lower incidence of adverse reactions contributes to MEPRON's market appeal[1][4].

Market Performance and Sales

MEPRON is part of the broader portfolio of GlaxoSmithKline (GSK), a major pharmaceutical company. While specific sales figures for MEPRON are not always publicly disclosed, GSK's annual reports indicate strong performance in their infectious diseases segment, which includes MEPRON. The company's overall strategy to modernize its business and focus on core therapy areas, including infectious diseases, supports the continued market presence of MEPRON[3].

Generic Competition

The availability of generic atovaquone has introduced competition into the market, potentially affecting the sales of the branded version of MEPRON. However, the brand loyalty and the established safety and efficacy profile of MEPRON help it maintain a significant market share despite generic competition[2].

Future Outlook

The future outlook for MEPRON is influenced by several factors, including the ongoing need for effective treatments for PCP, the evolution of HIV/AIDS management, and the competitive landscape. As GSK continues to invest in its infectious diseases portfolio and patient assistance programs, MEPRON is likely to remain a critical component of the antimicrobial market.

Financial Trajectory

The financial trajectory of MEPRON is tied to the overall performance of GSK's infectious diseases segment. With a strong focus on core therapy areas and significant investments in R&D, GSK is well-positioned to maintain and potentially grow the market share of MEPRON. The availability of generic versions may impact revenue, but the brand's reputation and clinical advantages are expected to sustain its financial performance.

Key Takeaways

• Market Indications: MEPRON is used for the prevention and treatment of PCP in patients intolerant to TMP-SMX.
• Competitive Landscape: MEPRON competes with TMP-SMX but has a better safety profile.
• Pricing and Cost: MEPRON is expensive, but generic versions and patient assistance programs are available.
• Clinical Trials and Efficacy: MEPRON has shown comparable efficacy to TMP-SMX with fewer adverse reactions.
• Adverse Reactions and Safety Profile: Common adverse reactions are less frequent and severe than those of TMP-SMX.
• Market Performance and Sales: Part of GSK's strong infectious diseases segment.
• Generic Competition: Generic atovaquone is available, but MEPRON maintains market share due to brand loyalty and clinical advantages.
• Future Outlook: Continued need for effective PCP treatments and GSK's strategic investments support MEPRON's market presence.

FAQs

What is MEPRON used for?

MEPRON (atovaquone) is used for the prevention and treatment of Pneumocystis jirovecii pneumonia (PCP) in adults and adolescents aged 13 years and older who cannot tolerate trimethoprim-sulfamethoxazole (TMP-SMX)[4].

How much does MEPRON cost?

The cost of MEPRON oral suspension can be around $1,476 for a 210-milliliter supply. However, generic versions are available at lower prices, starting from around $193.65 for 90 milliliters[2].

What are the common adverse reactions of MEPRON?

Common adverse reactions include rash, nausea, diarrhea, and vomiting. These reactions are generally less frequent and severe compared to those associated with TMP-SMX[1][4].

Is MEPRON available in generic form?

Yes, a generic version of atovaquone is available, which can be more affordable than the branded version[2].

How does MEPRON compare to TMP-SMX in terms of efficacy and safety?

MEPRON has shown comparable efficacy to TMP-SMX but with a better safety profile, as it results in fewer adverse reactions and discontinuations due to these reactions[1][4].

Sources

1. Mepron Product Monograph - GSK Canada
2. Mepron Prices, Coupons, Copay Cards & Patient Assistance - Drugs.com
3. Annual Report 2015 - GSK
4. Mepron: Package Insert / Prescribing Information - Drugs.com
5. MEPRON Suspension - GSK Pro