FDA Orange Book
Is there a generic for Tagrisso?
Tagrisso contains osimertinib. 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 Tagrisso (osimertinib). The Orange Book shows its last listed patent expires November 26, 2042 and its last listed exclusivity ends December 18, 2027.
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Tagrisso products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | EQ 40MG BASE | Marketed (Rx) | None | 0 | None |
| tablet, oral | EQ 80MG BASE | Marketed (Rx) | None | 0 | None |
NDA 208065, held by ASTRAZENECA PHARMACEUTICALS LP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Tagrisso patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9732058 | July 25, 2032 | Drug substance, Drug product | U-1777 | 208065 |
| 9732058 | July 25, 2032 | Drug substance, Drug product | U-2289 | 208065 |
| 9732058 | July 25, 2032 | Drug substance, Drug product | U-3016 | 208065 |
| 9732058 | July 25, 2032 | Drug substance, Drug product | U-4010 | 208065 |
| 9732058 | July 25, 2032 | Drug substance, Drug product | U-3823 | 208065 |
| 11524951 | July 25, 2032 | Drug substance, Drug product | None | 208065 |
| 8946235 | August 8, 2032 | Drug substance, Drug product | U-1777 | 208065 |
| 8946235 | August 8, 2032 | Drug substance, Drug product | U-2289 | 208065 |
| 8946235 | August 8, 2032 | Drug substance, Drug product | U-3016 | 208065 |
| 8946235 | August 8, 2032 | Drug substance, Drug product | U-4010 | 208065 |
| 8946235 | August 8, 2032 | Drug substance, Drug product | U-3823 | 208065 |
| 10183020 | January 2, 2035 | Drug product | U-1777 | 208065 |
| 10183020 | January 2, 2035 | Drug product | U-3016 | 208065 |
| 10183020 | January 2, 2035 | Drug product | U-4010 | 208065 |
| 10183020 | January 2, 2035 | Drug product | U-2289 | 208065 |
| 10183020 | January 2, 2035 | Drug product | U-3823 | 208065 |
| 12465608 | November 26, 2042 | Method of use | U-3823 | 208065 |
Tagrisso exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| I-941 | New indication | February 16, 2027 | 208065 |
| I-952 | New indication | September 25, 2027 | 208065 |
| ODE-337 | Orphan drug exclusivity | December 18, 2027 | 208065 |
Tagrisso NDC codes
Questions
Is there a generic for Tagrisso?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Tagrisso (osimertinib). The Orange Book shows its last listed patent expires November 26, 2042 and its last listed exclusivity ends December 18, 2027.
What is the generic name for Tagrisso?
The active ingredient in Tagrisso is osimertinib, per the FDA Orange Book.
When does the Tagrisso patent expire?
The last patent listed for Tagrisso in the Orange Book expires November 26, 2042. 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.