MEPRON Drug Patent Profile

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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. Nineteen 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.

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Summary for MEPRON

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	165
Clinical Trials:	2
Patent Applications:	5,040
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for MEPRON
What excipients (inactive ingredients) are in MEPRON?	MEPRON excipients list
DailyMed Link:	MEPRON at DailyMed

Drug patent expirations by year 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

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Glossary

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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	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Glaxosmithkline Llc	MEPRON	atovaquone	TABLET;ORAL	020259-001	Nov 25, 1992		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for MEPRON

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

International Patents for MEPRON

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

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Country	Patent Number	Title	Estimated Expiration
Norway	316745		⤷ Sign Up
New Zealand	230313	PHARMACEUTICAL FORMULATIONS COMPRISING A NAPHTHOQUINONE ADAPTED FOR NASAL ADMINISTRATION, NAPHTHOQUINONE DERIVATIVES, PREPARATION AND USE THEREOF	⤷ Sign Up
African Regional IP Organization (ARIPO)	8900136		⤷ Sign Up
Hong Kong	103395	Naphthoquiones for the treatment and prophylaxis of pneumocystis carinii infections	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for MEPRON

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