Orange Book product · Brand (NDA)
LINZESS
LINACLOTIDE
At a glance
Aug 30, 2012
Approved
Brand (NDA)
Application
Not listed
TE code
16
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 30, 2012
14 yr ago
Exclusivity ends · I-921
New indication exclusivity (3 years)
Jun 12, 2026
7 d ago
Today
Patent 7304036 expires
Listed drug substance patent expiration.
Aug 30, 2026
in 2 mo
Patent 7304036 expires
Listed drug substance patent expiration.
Aug 30, 2026
in 2 mo
Patent 7304036 expires
Listed drug substance patent expiration.
Aug 30, 2026
in 2 mo
Patent 7304036*PED expires
Listed listed patent expiration.
Feb 28, 2027
in 8 mo
Exclusivity ends · NPP
New patient population exclusivity (3 years)
Nov 04, 2028
in 2 yr 5 mo
Exclusivity ends · PED
Pediatric exclusivity (adds 6 months)
May 04, 2029
in 2 yr 11 mo
Patent 8933030 expires
Listed drug product patent expiration.
Feb 17, 2031
in 4 yr 9 mo
Patent 8933030*PED expires
Listed listed patent expiration.
Aug 17, 2031
in 5 yr 3 mo
Patent 8748573 expires
Listed method-of-use patent (U-1515) expiration.
Oct 30, 2031
in 5 yr 5 mo
Patent 8748573 expires
Listed method-of-use patent (U-1516) expiration.
Oct 30, 2031
in 5 yr 5 mo
Patent 8748573 expires
Listed method-of-use patent (U-4345) expiration.
Oct 30, 2031
in 5 yr 5 mo
Patent 8802628 expires
Listed drug product patent expiration.
Oct 30, 2031
in 5 yr 5 mo
Patent 8748573*PED expires
Listed listed patent expiration.
Apr 30, 2032
in 5 yr 11 mo
Patent 8802628*PED expires
Listed listed patent expiration.
Apr 30, 2032
in 5 yr 11 mo
Patent 9708371 expires
Listed drug product patent expiration.
Aug 16, 2033
in 7 yr 3 mo
Patent 9708371 expires
Listed drug product patent expiration.
Aug 16, 2033
in 7 yr 3 mo
Patent 9708371 expires
Listed drug product patent expiration.
Aug 16, 2033
in 7 yr 3 mo
Patent 9708371*PED expires
Listed listed patent expiration.
Feb 16, 2034
in 7 yr 9 mo
Pharmaceutical detail
Active ingredient
LINACLOTIDE
Strength
145MCG
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 202811
Product number
001
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)
- I-921New indication exclusivity (3 years)
Jun 12, 2026
7 d ago
- NPPNew patient population exclusivity (3 years)
Nov 04, 2028
in 2 yr 5 mo
- PEDPediatric exclusivity (adds 6 months)
May 04, 2029
in 2 yr 11 mo
Listed patents (16)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7304036 | Aug 30, 2026 | in 2 mo | SubstanceProductU-1278 |
| 7304036 | Aug 30, 2026 | in 2 mo | SubstanceProductU-4345 |
| 7304036 | Aug 30, 2026 | in 2 mo | SubstanceProductU-1516 |
| 7304036*PED | Feb 28, 2027 | in 8 mo | |
| 8933030 | Feb 17, 2031 | in 4 yr 9 mo | ProductU-4345 |
| 8933030*PED | Aug 17, 2031 | in 5 yr 3 mo | |
| 8748573 | Oct 30, 2031 | in 5 yr 5 mo | U-1515 |
| 8748573 | Oct 30, 2031 | in 5 yr 5 mo | U-1516 |
| 8748573 | Oct 30, 2031 | in 5 yr 5 mo | U-4345 |
| 8802628 | Oct 30, 2031 | in 5 yr 5 mo | Product |
| 8748573*PED | Apr 30, 2032 | in 5 yr 11 mo | |
| 8802628*PED | Apr 30, 2032 | in 5 yr 11 mo | |
| 9708371 | Aug 16, 2033 | in 7 yr 3 mo | ProductU-1515 |
| 9708371 | Aug 16, 2033 | in 7 yr 3 mo | ProductU-1516 |
| 9708371 | Aug 16, 2033 | in 7 yr 3 mo | ProductU-4345 |
| 9708371*PED | Feb 16, 2034 | in 7 yr 9 mo |
