FDA Orange Book
Generic for Zometa
Zometa contains zoledronic acid. 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 Zometa is zoledronic acid. 13 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP. Generics match 2 of the 3 Zometa products the Orange Book lists.
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Zometa products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, intravenous | EQ 4MG BASE/100ML | Discontinued | None | 3 | AP |
| injectable, intravenous | EQ 4MG BASE/5ML | Discontinued | None | 12 | AP |
| injectable, intravenous | EQ 4MG BASE/VIAL | Discontinued | None | 0 | None |
NDA 021223, 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 zoledronic acid
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| DR REDDYS LABORATORIES LTD | 091186 | AP (A-rated, therapeutically equivalent) | March 4, 2013 | EQ 4MG BASE/5ML |
| MYLAN LABORATORIES LTD | 202650 | AP (A-rated, therapeutically equivalent) | March 4, 2013 | EQ 4MG BASE/5ML |
| AVET LIFESCIENCES LTD | 201783 | AP (A-rated, therapeutically equivalent) | March 12, 2013 | EQ 4MG BASE/5ML |
| CHARTWELL RX SCIENCES LLC | 202571 | AP (A-rated, therapeutically equivalent) | May 7, 2013 | EQ 4MG BASE/5ML |
| HIKMA FARMACEUTICA SA | 202182 | AP (A-rated, therapeutically equivalent) | June 3, 2013 | EQ 4MG BASE/5ML |
| GLAND PHARMA LTD | 202930 | AP (A-rated, therapeutically equivalent) | August 5, 2013 | EQ 4MG BASE/5ML |
| EPIC PHARMA LLC | 202548 | AP (A-rated, therapeutically equivalent) | May 22, 2014 | EQ 4MG BASE/5ML |
| USV PRIVATE LTD | 202923 | AP (A-rated, therapeutically equivalent) | September 4, 2014 | EQ 4MG BASE/5ML |
| SAGENT PHARMACEUTICALS INC | 091493 | AP (A-rated, therapeutically equivalent) | November 24, 2014 | EQ 4MG BASE/5ML |
| FRESENIUS KABI USA LLC | 091516 | AP (A-rated, therapeutically equivalent) | April 23, 2015 | EQ 4MG BASE/5ML |
| ACCORD HEALTHCARE INC | 205279 | AP (A-rated, therapeutically equivalent) | November 28, 2016 | EQ 4MG BASE/5ML |
| AMNEAL EU LTD | 210174 | AP (A-rated, therapeutically equivalent) | October 27, 2017 | EQ 4MG BASE/100ML |
| BPI LABS LLC | 207341 | AP (A-rated, therapeutically equivalent) | December 29, 2017 | EQ 4MG BASE/5ML |
| GLAND PHARMA LTD | 205749 | AP (A-rated, therapeutically equivalent) | June 29, 2018 | EQ 4MG BASE/100ML |
| GLAND PHARMA LTD | 219984 | AP (A-rated, therapeutically equivalent) | February 5, 2026 | EQ 4MG BASE/100ML |
Zometa patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7932241 | February 5, 2028 | Drug product | None | 021223 |
Questions
Is there a generic for Zometa?
Yes. The generic name for Zometa is zoledronic acid. 13 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP. Generics match 2 of the 3 Zometa products the Orange Book lists.
What is the generic name for Zometa?
The active ingredient in Zometa is zoledronic acid, per the FDA Orange Book.
When does the Zometa patent expire?
The last patent listed for Zometa in the Orange Book expires February 5, 2028. A listed patent expiry date is not a generic launch date.
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.