FDA Orange Book
Generic for Starlix
Starlix contains nateglinide. 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 Starlix is nateglinide. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Starlix products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 120MG | Discontinued | None | 6 | AB |
| tablet, oral | 60MG | Discontinued | None | 6 | AB |
NDA 021204, held by NOVARTIS PHARMACEUTICALS CORP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic nateglinide
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| DR REDDYS LABORATORIES LTD | 077461 | AB (A-rated, therapeutically equivalent) | September 9, 2009 | 120MG, 60MG |
| STRIDES PHARMA INTERNATIONAL AG | 077463 | AB (A-rated, therapeutically equivalent) | September 9, 2009 | 120MG, 60MG |
| WATSON LABORATORIES INC | 077462 | AB (A-rated, therapeutically equivalent) | March 30, 2011 | 120MG, 60MG |
| ZYDUS PHARMACEUTICALS USA INC | 205248 | AB (A-rated, therapeutically equivalent) | July 6, 2016 | 120MG, 60MG |
| RISING PHARMA HOLDINGS INC | 205544 | AB (A-rated, therapeutically equivalent) | June 18, 2018 | 120MG, 60MG |
| CADILA PHARMACEUTICALS LTD | 206432 | AB (A-rated, therapeutically equivalent) | April 19, 2019 | 120MG, 60MG |
Questions
Is there a generic for Starlix?
Yes. The generic name for Starlix is nateglinide. 6 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 Starlix?
The active ingredient in Starlix is nateglinide, 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.