Orange Book product · Brand (NDA)
LINZESS
LINACLOTIDE
At a glance
Jan 25, 2017
Approved
Brand (NDA)
Application
Not listed
TE code
14
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 25, 2017
9 yr 6 mo 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*PED expires
Listed listed patent expiration.
Feb 28, 2027
in 8 mo
Patent 8933030 expires
Listed drug product patent expiration.
Feb 17, 2031
in 4 yr 9 mo
Patent 8933030 expires
Listed drug product patent expiration.
Feb 17, 2031
in 4 yr 9 mo
Patent 10675325 expires
Listed drug product patent expiration.
Aug 11, 2031
in 5 yr 3 mo
Patent 10702576 expires
Listed method-of-use patent (U-1516) expiration.
Aug 11, 2031
in 5 yr 3 mo
Patent 10702576 expires
Listed method-of-use patent (U-3644) expiration.
Aug 11, 2031
in 5 yr 3 mo
Patent 8933030*PED expires
Listed listed patent expiration.
Aug 17, 2031
in 5 yr 3 mo
Patent 10675325*PED expires
Listed listed patent expiration.
Feb 11, 2032
in 5 yr 9 mo
Patent 10702576*PED expires
Listed listed patent expiration.
Feb 11, 2032
in 5 yr 9 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
72MCG
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 202811
Product number
003
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 (1)
- I-921New indication exclusivity (3 years)
Jun 12, 2026
7 d ago
Listed patents (14)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7304036 | Aug 30, 2026 | in 2 mo | SubstanceProductU-1516 |
| 7304036 | Aug 30, 2026 | in 2 mo | SubstanceProductU-3644 |
| 7304036*PED | Feb 28, 2027 | in 8 mo | |
| 8933030 | Feb 17, 2031 | in 4 yr 9 mo | ProductU-1516 |
| 8933030 | Feb 17, 2031 | in 4 yr 9 mo | ProductU-3644 |
| 10675325 | Aug 11, 2031 | in 5 yr 3 mo | Product |
| 10702576 | Aug 11, 2031 | in 5 yr 3 mo | U-1516 |
| 10702576 | Aug 11, 2031 | in 5 yr 3 mo | U-3644 |
| 8933030*PED | Aug 17, 2031 | in 5 yr 3 mo | |
| 10675325*PED | Feb 11, 2032 | in 5 yr 9 mo | |
| 10702576*PED | Feb 11, 2032 | in 5 yr 9 mo | |
| 9708371 | Aug 16, 2033 | in 7 yr 3 mo | ProductU-1516 |
| 9708371 | Aug 16, 2033 | in 7 yr 3 mo | ProductU-3644 |
| 9708371*PED | Feb 16, 2034 | in 7 yr 9 mo |
