Orange Book product · Brand (NDA)
MOUNJARO
TIRZEPATIDE
At a glance
Jul 28, 2023
Approved
Brand (NDA)
Application
Not listed
TE code
28
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 28, 2023
2 yr 11 mo ago
Today
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
May 13, 2027
in 11 mo
Exclusivity ends · NPP
New patient population exclusivity (3 years)
Dec 19, 2028
in 2 yr 6 mo
Patent 9474780 expires
Listed drug substance patent expiration.
Jan 05, 2036
in 9 yr 8 mo
Patent 11357820 expires
Listed drug substance patent expiration.
Jun 14, 2039
in 13 yr 2 mo
Patent 12453755 expires
Listed method-of-use patent (U-4386) expiration.
Jun 14, 2039
in 13 yr 2 mo
Patent 12453755 expires
Listed method-of-use patent (U-4380) expiration.
Jun 14, 2039
in 13 yr 2 mo
Patent 12453755 expires
Listed method-of-use patent (U-4383) expiration.
Jun 14, 2039
in 13 yr 2 mo
Patent 12453755 expires
Listed method-of-use patent (U-4378) expiration.
Jun 14, 2039
in 13 yr 2 mo
Patent 12453755 expires
Listed method-of-use patent (U-4375) expiration.
Jun 14, 2039
in 13 yr 2 mo
Patent 12453755 expires
Listed method-of-use patent (U-4385) expiration.
Jun 14, 2039
in 13 yr 2 mo
Patent 12453755 expires
Listed method-of-use patent (U-4384) expiration.
Jun 14, 2039
in 13 yr 2 mo
Patent 12453755 expires
Listed method-of-use patent (U-4376) expiration.
Jun 14, 2039
in 13 yr 2 mo
Patent 12453755 expires
Listed method-of-use patent (U-4382) expiration.
Jun 14, 2039
in 13 yr 2 mo
Patent 12453755 expires
Listed method-of-use patent (U-4379) expiration.
Jun 14, 2039
in 13 yr 2 mo
Patent 12453755 expires
Listed method-of-use patent (U-4381) expiration.
Jun 14, 2039
in 13 yr 2 mo
Patent 12453755 expires
Listed method-of-use patent (U-4377) expiration.
Jun 14, 2039
in 13 yr 2 mo
Patent 12453756 expires
Listed drug product patent expiration.
Jun 14, 2039
in 13 yr 2 mo
Patent 12629404 expires
Listed drug product patent expiration.
Jun 14, 2039
in 13 yr 2 mo
Patent 12629404 expires
Listed drug product patent expiration.
Jun 14, 2039
in 13 yr 2 mo
Patent 12343382 expires
Listed method-of-use patent (U-4229) expiration.
Jul 22, 2039
in 13 yr 3 mo
Patent 12343382 expires
Listed method-of-use patent (U-4230) expiration.
Jul 22, 2039
in 13 yr 3 mo
Patent 12343382 expires
Listed method-of-use patent (U-4231) expiration.
Jul 22, 2039
in 13 yr 3 mo
Patent 12343382 expires
Listed method-of-use patent (U-4232) expiration.
Jul 22, 2039
in 13 yr 3 mo
Patent 12343382 expires
Listed method-of-use patent (U-4401) expiration.
Jul 22, 2039
in 13 yr 3 mo
Patent 12343382 expires
Listed method-of-use patent (U-4400) expiration.
Jul 22, 2039
in 13 yr 3 mo
Patent 12616740 expires
Listed method-of-use patent (U-4500) expiration.
Jul 22, 2039
in 13 yr 3 mo
Patent 12616740 expires
Listed method-of-use patent (U-4501) expiration.
Jul 22, 2039
in 13 yr 3 mo
Patent 12616740 expires
Listed method-of-use patent (U-4502) expiration.
Jul 22, 2039
in 13 yr 3 mo
Patent 12295987 expires
Listed method-of-use patent (U-4193) expiration.
Dec 30, 2041
in 15 yr 9 mo
Patent 12295987 expires
Listed method-of-use patent (U-4192) expiration.
Dec 30, 2041
in 15 yr 9 mo
Pharmaceutical detail
Active ingredient
TIRZEPATIDE
Strength
2.5MG/0.5ML (2.5MG/0.5ML)
Dosage form
SOLUTION
Route
SUBCUTANEOUS
TE code
Not listed
Application
NDA 215866
Product number
007
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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 (2)
- NCENew chemical entity exclusivity (5 years)
May 13, 2027
in 11 mo
- NPPNew patient population exclusivity (3 years)
Dec 19, 2028
in 2 yr 6 mo
Listed patents (28)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9474780 | Jan 05, 2036 | in 9 yr 8 mo | SubstanceProductU-4374 |
| 11357820 | Jun 14, 2039 | in 13 yr 2 mo | SubstanceProduct |
| 12453755 | Jun 14, 2039 | in 13 yr 2 mo | U-4386 |
| 12453755 | Jun 14, 2039 | in 13 yr 2 mo | U-4380 |
| 12453755 | Jun 14, 2039 | in 13 yr 2 mo | U-4383 |
| 12453755 | Jun 14, 2039 | in 13 yr 2 mo | U-4378 |
| 12453755 | Jun 14, 2039 | in 13 yr 2 mo | U-4375 |
| 12453755 | Jun 14, 2039 | in 13 yr 2 mo | U-4385 |
| 12453755 | Jun 14, 2039 | in 13 yr 2 mo | U-4384 |
| 12453755 | Jun 14, 2039 | in 13 yr 2 mo | U-4376 |
| 12453755 | Jun 14, 2039 | in 13 yr 2 mo | U-4382 |
| 12453755 | Jun 14, 2039 | in 13 yr 2 mo | U-4379 |
| 12453755 | Jun 14, 2039 | in 13 yr 2 mo | U-4381 |
| 12453755 | Jun 14, 2039 | in 13 yr 2 mo | U-4377 |
| 12453756 | Jun 14, 2039 | in 13 yr 2 mo | Product |
| 12629404 | Jun 14, 2039 | in 13 yr 2 mo | ProductU-4533 |
| 12629404 | Jun 14, 2039 | in 13 yr 2 mo | ProductU-4534 |
| 12343382 | Jul 22, 2039 | in 13 yr 3 mo | U-4229 |
| 12343382 | Jul 22, 2039 | in 13 yr 3 mo | U-4230 |
| 12343382 | Jul 22, 2039 | in 13 yr 3 mo | U-4231 |
| 12343382 | Jul 22, 2039 | in 13 yr 3 mo | U-4232 |
| 12343382 | Jul 22, 2039 | in 13 yr 3 mo | U-4401 |
| 12343382 | Jul 22, 2039 | in 13 yr 3 mo | U-4400 |
| 12616740 | Jul 22, 2039 | in 13 yr 3 mo | U-4500 |
| 12616740 | Jul 22, 2039 | in 13 yr 3 mo | U-4501 |
| 12616740 | Jul 22, 2039 | in 13 yr 3 mo | U-4502 |
| 12295987 | Dec 30, 2041 | in 15 yr 9 mo | U-4193 |
| 12295987 | Dec 30, 2041 | in 15 yr 9 mo | U-4192 |

