FDA Orange Book
Generic for Lopurin
Lopurin contains allopurinol. 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 Lopurin is allopurinol. 12 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Lopurin products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 100MG | Discontinued | None | 12 | AB |
| tablet, oral | 300MG | Discontinued | None | 12 | AB |
NDA 018297, held by ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic allopurinol
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| MYLAN PHARMACEUTICALS INC | 018659 | AB (A-rated, therapeutically equivalent) | October 24, 1986 | 100MG, 300MG |
| SUN PHARMACEUTICAL INDUSTRIES INC | 071450 | AB (A-rated, therapeutically equivalent) | January 9, 1987 | 100MG, 300MG |
| DR REDDYS LABORATORIES INC | 071587 | AB (A-rated, therapeutically equivalent) | April 2, 1987 | 100MG, 300MG |
| PH HEALTH LTD | 075798 | AB (A-rated, therapeutically equivalent) | June 27, 2003 | 100MG, 300MG |
| CHARTWELL LIFE MOLECULES LLC | 077353 | AB (A-rated, therapeutically equivalent) | September 8, 2005 | 100MG, 300MG |
| ACCORD HEALTHCARE INC | 203154 | AB (A-rated, therapeutically equivalent) | May 6, 2013 | 100MG, 300MG |
| REGCON HOLDINGS LLC | 204467 | AB (A-rated, therapeutically equivalent) | July 28, 2016 | 100MG, 300MG |
| ZYDUS PHARMACEUTICALS USA INC | 210117 | AB (A-rated, therapeutically equivalent) | October 12, 2017 | 100MG, 300MG |
| UNICHEM LABORATORIES LTD | 211820 | AB (A-rated, therapeutically equivalent) | March 12, 2019 | 100MG, 300MG |
| HARMAN FINOCHEM LTD | 214443 | AB (A-rated, therapeutically equivalent) | March 7, 2022 | 100MG, 300MG |
| HETERO LABS LTD UNIT V | 217748 | AB (A-rated, therapeutically equivalent) | August 3, 2023 | 100MG, 300MG |
| AUROBINDO PHARMA LTD | 215091 | AB (A-rated, therapeutically equivalent) | April 14, 2025 | 100MG, 300MG |
Questions
Is there a generic for Lopurin?
Yes. The generic name for Lopurin is allopurinol. 12 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Lopurin?
The active ingredient in Lopurin is allopurinol, 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.