Orange Book product · Brand (NDA)
ZEPBOUND
TIRZEPATIDE
At a glance
Mar 28, 2024
Approved
Brand (NDA)
Application
Not listed
TE code
17
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 28, 2024
2 yr 3 mo ago
Today
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
May 13, 2027
in 11 mo
Exclusivity ends · M-82
New use / labeling-change exclusivity (3 years)
Oct 18, 2027
in 1 yr 4 mo
Exclusivity ends · I-958
New indication exclusivity (3 years)
Dec 20, 2027
in 1 yr 6 mo
Patent 9474780 expires
Listed drug substance patent expiration.
Jan 05, 2036
in 9 yr 8 mo
Patent 11357820 expires
Listed drug product patent expiration.
Jun 14, 2039
in 13 yr 2 mo
Patent 11918623 expires
Listed method-of-use patent (U-3855) 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-4228) expiration.
Jul 22, 2039
in 13 yr 3 mo
Patent 12343382 expires
Listed method-of-use patent (U-4227) expiration.
Jul 22, 2039
in 13 yr 3 mo
Patent 12343382 expires
Listed method-of-use patent (U-4410) expiration.
Jul 22, 2039
in 13 yr 3 mo
Patent 12343382 expires
Listed method-of-use patent (U-4409) expiration.
Jul 22, 2039
in 13 yr 3 mo
Patent 12453758 expires
Listed method-of-use patent (U-4311) expiration.
Jul 22, 2039
in 13 yr 3 mo
Patent 12453758 expires
Listed method-of-use patent (U-4310) expiration.
Jul 22, 2039
in 13 yr 3 mo
Patent 12453758 expires
Listed method-of-use patent (U-4309) expiration.
Jul 22, 2039
in 13 yr 3 mo
Patent 12453758 expires
Listed method-of-use patent (U-4308) expiration.
Jul 22, 2039
in 13 yr 3 mo
Patent 12616740 expires
Listed method-of-use patent (U-4497) expiration.
Jul 22, 2039
in 13 yr 3 mo
Patent 12616740 expires
Listed method-of-use patent (U-4498) expiration.
Jul 22, 2039
in 13 yr 3 mo
Patent 12616740 expires
Listed method-of-use patent (U-4499) expiration.
Jul 22, 2039
in 13 yr 3 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 217806
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 (3)
- NCENew chemical entity exclusivity (5 years)
May 13, 2027
in 11 mo
- M-82New use / labeling-change exclusivity (3 years)
Oct 18, 2027
in 1 yr 4 mo
- I-958New indication exclusivity (3 years)
Dec 20, 2027
in 1 yr 6 mo
Listed patents (17)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9474780 | Jan 05, 2036 | in 9 yr 8 mo | SubstanceProduct |
| 11357820 | Jun 14, 2039 | in 13 yr 2 mo | Product |
| 11918623 | Jun 14, 2039 | in 13 yr 2 mo | U-3855 |
| 12453756 | Jun 14, 2039 | in 13 yr 2 mo | Product |
| 12629404 | Jun 14, 2039 | in 13 yr 2 mo | ProductU-4531 |
| 12629404 | Jun 14, 2039 | in 13 yr 2 mo | ProductU-4532 |
| 12343382 | Jul 22, 2039 | in 13 yr 3 mo | U-4228 |
| 12343382 | Jul 22, 2039 | in 13 yr 3 mo | U-4227 |
| 12343382 | Jul 22, 2039 | in 13 yr 3 mo | U-4410 |
| 12343382 | Jul 22, 2039 | in 13 yr 3 mo | U-4409 |
| 12453758 | Jul 22, 2039 | in 13 yr 3 mo | U-4311 |
| 12453758 | Jul 22, 2039 | in 13 yr 3 mo | U-4310 |
| 12453758 | Jul 22, 2039 | in 13 yr 3 mo | U-4309 |
| 12453758 | Jul 22, 2039 | in 13 yr 3 mo | U-4308 |
| 12616740 | Jul 22, 2039 | in 13 yr 3 mo | U-4497 |
| 12616740 | Jul 22, 2039 | in 13 yr 3 mo | U-4498 |
| 12616740 | Jul 22, 2039 | in 13 yr 3 mo | U-4499 |
