FDA Orange Book
Generic for Mepron
Mepron contains atovaquone. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Mepron is atovaquone. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 1 of the 2 Mepron products the Orange Book lists.
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Mepron products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| suspension, oral | 750MG/5ML | Marketed (Rx) | AB | 7 | AB |
| tablet, oral | 250MG | Discontinued | None | 0 | None |
NDA 020500, 020259, held by GLAXOSMITHKLINE LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic atovaquone
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| AMNEAL PHARMACEUTICALS | 202960 | AB (A-rated, therapeutically equivalent) | March 18, 2014 | 750MG/5ML |
| CHARTWELL RX SCIENCES LLC | 207833 | AB (A-rated, therapeutically equivalent) | April 28, 2017 | 750MG/5ML |
| HETERO LABS LTD UNIT III | 210692 | AB (A-rated, therapeutically equivalent) | October 11, 2018 | 750MG/5ML |
| GLENMARK SPECIALTY SA | 209685 | AB (A-rated, therapeutically equivalent) | November 21, 2018 | 750MG/5ML |
| ABHAI LLC | 210510 | AB (A-rated, therapeutically equivalent) | May 31, 2019 | 750MG/5ML |
| BIONPHARMA INC | 212918 | AB (A-rated, therapeutically equivalent) | March 30, 2021 | 750MG/5ML |
| PAI HOLDINGS LLC DBA PHARMACEUTICAL ASSOCIATES INC AND DBA PAI PHARMA | 214272 | AB (A-rated, therapeutically equivalent) | October 25, 2021 | 750MG/5ML |
Mepron NDC codes
Questions
Is there a generic for Mepron?
Yes. The generic name for Mepron is atovaquone. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 1 of the 2 Mepron products the Orange Book lists.
What is the generic name for Mepron?
The active ingredient in Mepron is atovaquone, per the FDA Orange Book.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.