FDA Orange Book
Generic for Fosamax
Fosamax contains alendronate. 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 Fosamax is alendronate. 9 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA, AB.
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Fosamax products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, oral | EQ 70MG BASE/75ML | Discontinued | None | 3 | AA |
| tablet, oral | EQ 10MG BASE | Discontinued | None | 5 | AB |
| tablet, oral | EQ 35MG BASE | Discontinued | None | 6 | AB |
| tablet, oral | EQ 40MG BASE | Discontinued | None | 3 | AB |
| tablet, oral | EQ 5MG BASE | Discontinued | None | 3 | AB |
| tablet, oral | EQ 70MG BASE | Marketed (Rx) | AB | 6 | AB |
NDA 021575, 020560, held by MERCK AND CO INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic alendronate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| AUROBINDO PHARMA LTD | 090124 | AB (A-rated, therapeutically equivalent) | August 4, 2008 | EQ 10MG BASE, EQ 35MG BASE, EQ 70MG BASE |
| CIPLA LTD | 076768 | AB (A-rated, therapeutically equivalent) | August 4, 2008 | EQ 10MG BASE, EQ 35MG BASE, EQ 40MG BASE, EQ 5MG BASE, EQ 70MG BASE |
| WATSON LABORATORIES INC | 076984 | AB (A-rated, therapeutically equivalent) | August 4, 2008 | EQ 35MG BASE, EQ 40MG BASE, EQ 70MG BASE |
| SUN PHARMACEUTICAL INDUSTRIES LTD | 090022 | AB (A-rated, therapeutically equivalent) | September 10, 2008 | EQ 10MG BASE, EQ 35MG BASE, EQ 5MG BASE, EQ 70MG BASE |
| HANGZHOU MINSHENG BINJIANG PHARMACEUTICAL CO LTD | 090258 | AB (A-rated, therapeutically equivalent) | September 24, 2009 | EQ 10MG BASE, EQ 35MG BASE, EQ 5MG BASE, EQ 70MG BASE |
| HIKMA PHARMACEUTICALS USA INC | 090520 | AA (A-rated, therapeutically equivalent) | February 25, 2013 | EQ 70MG BASE/75ML |
| NOVITIUM PHARMA LLC | 214512 | AA (A-rated, therapeutically equivalent) | May 11, 2023 | EQ 70MG BASE/75ML |
| IPCA LABORATORIES LTD | 206387 | AB (A-rated, therapeutically equivalent) | June 4, 2024 | EQ 10MG BASE, EQ 35MG BASE, EQ 40MG BASE, EQ 70MG BASE |
| PRECISION DOSE INC | 214523 | AA (A-rated, therapeutically equivalent) | September 2, 2026 | EQ 70MG BASE/75ML |
Fosamax NDC codes
Questions
Is there a generic for Fosamax?
Yes. The generic name for Fosamax is alendronate. 9 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA, AB.
What is the generic name for Fosamax?
The active ingredient in Fosamax is alendronate, 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.