FDA Orange Book
Generic for Kaletra
Kaletra contains lopinavir and ritonavir. 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 Kaletra is lopinavir and ritonavir. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 2 of the 4 Kaletra products the Orange Book lists.
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Kaletra products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 133.3MG;33.3MG | Discontinued | None | 0 | None |
| solution, oral | 80MG/ML;20MG/ML | Marketed (Rx) | None | 0 | None |
| tablet, oral | 100MG;25MG | Marketed (Rx) | AB | 5 | AB |
| tablet, oral | 200MG;50MG | Marketed (Rx) | AB | 5 | AB |
NDA 021226, 021251, 021906, held by ABBVIE INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic lopinavir and ritonavir
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| HETERO LABS LTD UNIT III | 091677 | AB (A-rated, therapeutically equivalent) | June 4, 2021 | 100MG;25MG, 200MG;50MG |
| LAURUS LABS LTD | 213857 | AB (A-rated, therapeutically equivalent) | March 21, 2022 | 100MG;25MG, 200MG;50MG |
| MYLAN LABORATORIES LTD | 079074 | AB (A-rated, therapeutically equivalent) | February 7, 2024 | 100MG;25MG, 200MG;50MG |
| MACLEODS PHARMACEUTICALS LTD | 204739 | AB (A-rated, therapeutically equivalent) | July 25, 2024 | 100MG;25MG, 200MG;50MG |
| MICRO LABS LTD | 214696 | AB (A-rated, therapeutically equivalent) | December 11, 2025 | 100MG;25MG, 200MG;50MG |
Kaletra NDC codes
Questions
Is there a generic for Kaletra?
Yes. The generic name for Kaletra is lopinavir and ritonavir. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 2 of the 4 Kaletra products the Orange Book lists.
What is the generic name for Kaletra?
The active ingredient in Kaletra is lopinavir and ritonavir, 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.