FDA Orange Book
Generic for Reclast
Reclast 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 Reclast is zoledronic acid. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
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Reclast products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, intravenous | EQ 5MG BASE/100ML | Marketed (Rx) | AP | 9 | AP |
NDA 021817, held by SANDOZ INC. 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 | 091363 | AP (A-rated, therapeutically equivalent) | March 29, 2013 | EQ 5MG BASE/100ML |
| CHARTWELL RX SCIENCES LLC | 202163 | AP (A-rated, therapeutically equivalent) | August 5, 2013 | EQ 5MG BASE/100ML |
| INFORLIFE SA | 202828 | AP (A-rated, therapeutically equivalent) | September 23, 2013 | EQ 5MG BASE/100ML |
| EPIC PHARMA LLC | 200918 | AP (A-rated, therapeutically equivalent) | August 21, 2014 | EQ 5MG BASE/100ML |
| GLAND PHARMA LTD | 204217 | AP (A-rated, therapeutically equivalent) | August 18, 2016 | EQ 5MG BASE/100ML |
| MYLAN LABORATORIES LTD | 203841 | AP (A-rated, therapeutically equivalent) | February 14, 2017 | EQ 5MG BASE/100ML |
| MYLAN LABORATORIES LTD | 205254 | AP (A-rated, therapeutically equivalent) | October 27, 2017 | EQ 5MG BASE/100ML |
| GLAND PHARMA LTD | 209578 | AP (A-rated, therapeutically equivalent) | August 8, 2019 | EQ 5MG BASE/100ML |
| MEITHEAL PHARMACEUTICALS INC | 213371 | AP (A-rated, therapeutically equivalent) | June 5, 2023 | EQ 5MG BASE/100ML |
Reclast patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7932241 | February 5, 2028 | Drug product | None | 021817 |
| 7932241*PED | August 5, 2028 | Method of use | None | 021817 |
Reclast NDC codes
Questions
Is there a generic for Reclast?
Yes. The generic name for Reclast is zoledronic acid. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
What is the generic name for Reclast?
The active ingredient in Reclast is zoledronic acid, per the FDA Orange Book.
When does the Reclast patent expire?
The last patent listed for Reclast in the Orange Book expires August 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.