FDA Orange Book
Generic for Janumet XR
Janumet XR contains sitagliptin and metformin. 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 Janumet XR is sitagliptin and metformin. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Janumet XR products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, extended release, oral | 1GM;EQ 100MG BASE | Marketed (Rx) | AB | 1 | AB |
| tablet, extended release, oral | 1GM;EQ 50MG BASE | Marketed (Rx) | AB | 1 | AB |
| tablet, extended release, oral | 500MG;EQ 50MG BASE | Marketed (Rx) | AB | 1 | AB |
NDA 202270, held by MERCK SHARP AND DOHME LLC A SUB OF 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 sitagliptin and metformin
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| PH HEALTH LTD | 204144 | AB (A-rated, therapeutically equivalent) | June 4, 2025 | 1GM;EQ 100MG BASE, 1GM;EQ 50MG BASE, 500MG;EQ 50MG BASE |
Janumet XR patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7326708 | November 24, 2026 | Drug substance, Drug product | U-1227 | 202270 |
| 7326708*PED | May 24, 2027 | Method of use | None | 202270 |
Janumet XR NDC codes
Questions
Is there a generic for Janumet XR?
Yes. The generic name for Janumet XR is sitagliptin and metformin. 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 Janumet XR?
The active ingredient in Janumet XR is sitagliptin and metformin, per the FDA Orange Book.
When does the Janumet XR patent expire?
The last patent listed for Janumet XR in the Orange Book expires May 24, 2027. 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.