FDA Orange Book
Generic for Boniva
Boniva contains ibandronate. 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 Boniva is ibandronate. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AP. Generics match 2 of the 3 Boniva products the Orange Book lists.
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Boniva products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, intravenous | EQ 3MG BASE/3ML | Discontinued | None | 3 | AP |
| tablet, oral | EQ 150MG BASE | Discontinued | None | 5 | AB |
| tablet, oral | EQ 2.5MG BASE | Discontinued | None | 0 | None |
NDA 021858, 021455, held by HOFFMANN LA ROCHE INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic ibandronate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| APOTEX INC | 078948 | AB (A-rated, therapeutically equivalent) | March 19, 2012 | EQ 150MG BASE |
| ORBION PHARMACEUTICALS PRIVATE LTD | 078998 | AB (A-rated, therapeutically equivalent) | March 19, 2012 | EQ 150MG BASE |
| DR REDDYS LABORATORIES LTD | 078997 | AB (A-rated, therapeutically equivalent) | April 30, 2012 | EQ 150MG BASE |
| EUGIA PHARMA SPECIALITIES LTD | 205332 | AP (A-rated, therapeutically equivalent) | August 19, 2015 | EQ 3MG BASE/3ML |
| APOTEX INC | 204222 | AP (A-rated, therapeutically equivalent) | October 16, 2015 | EQ 3MG BASE/3ML |
| ACCORD HEALTHCARE INC | 206058 | AP (A-rated, therapeutically equivalent) | February 5, 2016 | EQ 3MG BASE/3ML |
| AUROBINDO PHARMA LTD | 204502 | AB (A-rated, therapeutically equivalent) | March 11, 2016 | EQ 150MG BASE |
| MACLEODS PHARMACEUTICALS LTD | 206887 | AB (A-rated, therapeutically equivalent) | October 31, 2017 | EQ 150MG BASE |
Questions
Is there a generic for Boniva?
Yes. The generic name for Boniva is ibandronate. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AP. Generics match 2 of the 3 Boniva products the Orange Book lists.
What is the generic name for Boniva?
The active ingredient in Boniva is ibandronate, 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.