Orange Book product · Brand (NDA)
TAGRISSO
OSIMERTINIB MESYLATE
At a glance
Nov 13, 2015
Approved
Brand (NDA)
Application
Not listed
TE code
17
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 13, 2015
10 yr 9 mo ago
Today
Exclusivity ends · I-941
New indication exclusivity (3 years)
Feb 16, 2027
in 8 mo
Exclusivity ends · I-952
New indication exclusivity (3 years)
Sep 25, 2027
in 1 yr 3 mo
Exclusivity ends · ODE-337
Orphan-drug exclusivity (7 years)
Dec 18, 2027
in 1 yr 6 mo
Patent 11524951 expires
Listed drug substance patent expiration.
Jul 25, 2032
in 6 yr 2 mo
Patent 9732058 expires
Listed drug substance patent expiration.
Jul 25, 2032
in 6 yr 2 mo
Patent 9732058 expires
Listed drug substance patent expiration.
Jul 25, 2032
in 6 yr 2 mo
Patent 9732058 expires
Listed drug substance patent expiration.
Jul 25, 2032
in 6 yr 2 mo
Patent 9732058 expires
Listed drug substance patent expiration.
Jul 25, 2032
in 6 yr 2 mo
Patent 9732058 expires
Listed drug substance patent expiration.
Jul 25, 2032
in 6 yr 2 mo
Patent 8946235 expires
Listed drug substance patent expiration.
Aug 08, 2032
in 6 yr 3 mo
Patent 8946235 expires
Listed drug substance patent expiration.
Aug 08, 2032
in 6 yr 3 mo
Patent 8946235 expires
Listed drug substance patent expiration.
Aug 08, 2032
in 6 yr 3 mo
Patent 8946235 expires
Listed drug substance patent expiration.
Aug 08, 2032
in 6 yr 3 mo
Patent 8946235 expires
Listed drug substance patent expiration.
Aug 08, 2032
in 6 yr 3 mo
Patent 10183020 expires
Listed drug product patent expiration.
Jan 02, 2035
in 8 yr 8 mo
Patent 10183020 expires
Listed drug product patent expiration.
Jan 02, 2035
in 8 yr 8 mo
Patent 10183020 expires
Listed drug product patent expiration.
Jan 02, 2035
in 8 yr 8 mo
Patent 10183020 expires
Listed drug product patent expiration.
Jan 02, 2035
in 8 yr 8 mo
Patent 10183020 expires
Listed drug product patent expiration.
Jan 02, 2035
in 8 yr 8 mo
Patent 12465608 expires
Listed method-of-use patent (U-3823) expiration.
Nov 26, 2042
in 16 yr 8 mo
Pharmaceutical detail
Active ingredient
OSIMERTINIB MESYLATE
Strength
EQ 40MG BASE
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 208065
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Marketing exclusivity (3)
- I-941New indication exclusivity (3 years)
Feb 16, 2027
in 8 mo
- I-952New indication exclusivity (3 years)
Sep 25, 2027
in 1 yr 3 mo
- ODE-337Orphan-drug exclusivity (7 years)
Dec 18, 2027
in 1 yr 6 mo
Listed patents (17)
| Patent | Expires | In | Type |
|---|---|---|---|
| 11524951 | Jul 25, 2032 | in 6 yr 2 mo | SubstanceProduct |
| 9732058 | Jul 25, 2032 | in 6 yr 2 mo | SubstanceProductU-1777 |
| 9732058 | Jul 25, 2032 | in 6 yr 2 mo | SubstanceProductU-2289 |
| 9732058 | Jul 25, 2032 | in 6 yr 2 mo | SubstanceProductU-3016 |
| 9732058 | Jul 25, 2032 | in 6 yr 2 mo | SubstanceProductU-4010 |
| 9732058 | Jul 25, 2032 | in 6 yr 2 mo | SubstanceProductU-3823 |
| 8946235 | Aug 08, 2032 | in 6 yr 3 mo | SubstanceProductU-1777 |
| 8946235 | Aug 08, 2032 | in 6 yr 3 mo | SubstanceProductU-2289 |
| 8946235 | Aug 08, 2032 | in 6 yr 3 mo | SubstanceProductU-3016 |
| 8946235 | Aug 08, 2032 | in 6 yr 3 mo | SubstanceProductU-4010 |
| 8946235 | Aug 08, 2032 | in 6 yr 3 mo | SubstanceProductU-3823 |
| 10183020 | Jan 02, 2035 | in 8 yr 8 mo | ProductU-1777 |
| 10183020 | Jan 02, 2035 | in 8 yr 8 mo | ProductU-3016 |
| 10183020 | Jan 02, 2035 | in 8 yr 8 mo | ProductU-4010 |
| 10183020 | Jan 02, 2035 | in 8 yr 8 mo | ProductU-2289 |
| 10183020 | Jan 02, 2035 | in 8 yr 8 mo | ProductU-3823 |
| 12465608 | Nov 26, 2042 | in 16 yr 8 mo | U-3823 |
