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Last Updated: October 21, 2020

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MEPRON Drug 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. Twelve suppliers are listed for this compound. Additional details are available on the atovaquone profile page.

US ANDA Litigation and Generic Entry Outlook for Mepron

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

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Drug patent expirations by year for MEPRON
Drug Prices for MEPRON

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Recent Clinical Trials for MEPRON

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

SponsorPhase
Baylor College of MedicineEarly Phase 1
Texas Children's HospitalEarly Phase 1
William Marsh Rice UniversityEarly Phase 1

See all MEPRON clinical trials

Pharmacology for MEPRON
Paragraph IV (Patent) Challenges for MEPRON
Tradename Dosage Ingredient NDA Submissiondate
MEPRON SUSPENSION;ORAL atovaquone 020500 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   Start Trial   Start Trial   Start Trial
Glaxosmithkline Llc MEPRON atovaquone TABLET;ORAL 020259-001 Nov 25, 1992 DISCN Yes No   Start Trial   Start Trial   Start Trial
>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

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

Supplementary Protection Certificates for MEPRON

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0123238 95C0009 Belgium   Start Trial 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   Start Trial 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

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