FDA Orange Book
Is there a generic for Inlexzo?
Inlexzo contains gemcitabine. 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
No. The Orange Book lists no active FDA-approved generic (ANDA) for Inlexzo (gemcitabine). The Orange Book shows its last listed patent expires November 7, 2038 and its last listed exclusivity ends September 9, 2028.
Run it in Rivvi
Map Inlexzo and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Inlexzo products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| system, intravesical | EQ 225MG BASE | Marketed (Rx) | None | 0 | None |
NDA 219683, held by JANSSEN BIOTECH INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Inlexzo patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 12403086 | June 28, 2030 | Drug product | None | 219683 |
| 12576253 | December 17, 2030 | Drug product | None | 219683 |
| 8679094 | April 15, 2032 | Drug product | None | 219683 |
| 10729823 | August 19, 2034 | Drug product | None | 219683 |
| 12447241 | August 19, 2034 | Drug product | None | 219683 |
| 12636300 | November 7, 2038 | Method of use | U-4552 | 219683 |
Inlexzo exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NP | New product | September 9, 2028 | 219683 |
Inlexzo NDC codes
Questions
Is there a generic for Inlexzo?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Inlexzo (gemcitabine). The Orange Book shows its last listed patent expires November 7, 2038 and its last listed exclusivity ends September 9, 2028.
What is the generic name for Inlexzo?
The active ingredient in Inlexzo is gemcitabine, per the FDA Orange Book.
When does the Inlexzo patent expire?
The last patent listed for Inlexzo in the Orange Book expires November 7, 2038. 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.