FDA Orange Book
Generic for Atelvia
Atelvia contains risedronate. 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 Atelvia is risedronate. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Atelvia products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, delayed release, oral | 35MG | Marketed (Rx) | AB | 1 | AB |
NDA 022560, held by ALLERGAN PHARMACEUTICALS INTERNATIONAL LTD. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic risedronate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| TEVA PHARMACEUTICALS USA | 203217 | AB (A-rated, therapeutically equivalent) | May 18, 2015 | 35MG |
Atelvia patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8246989 | January 16, 2026 | Drug product | None | 022560 |
| 7645460 | January 9, 2028 | Drug product | U-662 | 022560 |
| 7645459 | January 9, 2028 | Drug product | U-662 | 022560 |
Atelvia NDC codes
Questions
Is there a generic for Atelvia?
Yes. The generic name for Atelvia is risedronate. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Atelvia?
The active ingredient in Atelvia is risedronate, per the FDA Orange Book.
When does the Atelvia patent expire?
The last patent listed for Atelvia in the Orange Book expires January 9, 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.