FDA Orange Book · active-ingredient family
Linaclotide
Linaclotide is approved as 1 brand and 2 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:LINZESS · NDA 202811
1
Brand (NDA)
2
Generics (ANDA)
14
Listed patents
4
Exclusivity periods
Brand (NDA) products · capsule
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| LINZESSRLD×3 | ABBVIE | NDA 202811 | — | Jan 25, 2017 |
Generic (ANDA) products (2)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| LINACLOTIDE×2 | AUROBINDO PHARMA | ANDA 209611 | — | Feb 07, 2023 | |
| LINACLOTIDE×2 | MYLAN | ANDA 209564 | — | Feb 09, 2021 |
Marketing exclusivity (4)
- I-921New indication exclusivity (3 years)
Jun 12, 2026
7 d ago
- 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 (14)
| Patent | Expires | In | Type |
|---|---|---|---|
| 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-1516 |
| 10702576 | Aug 11, 2031 | in 5 yr 3 mo | U-1516 |
| 10675325 | Aug 11, 2031 | in 5 yr 3 mo | Product |
| 8933030*PED | Aug 17, 2031 | in 5 yr 3 mo | |
| 8748573 | Oct 30, 2031 | in 5 yr 5 mo | U-1515 |
| 8802628 | Oct 30, 2031 | in 5 yr 5 mo | Product |
| 10675325*PED | Feb 11, 2032 | in 5 yr 9 mo | |
| 10702576*PED | Feb 11, 2032 | in 5 yr 9 mo | |
| 8802628*PED | Apr 30, 2032 | in 5 yr 11 mo | |
| 8748573*PED | Apr 30, 2032 | in 5 yr 11 mo | |
| 9708371 | Aug 16, 2033 | in 7 yr 3 mo | ProductU-1516 |
| 9708371*PED | Feb 16, 2034 | in 7 yr 9 mo |
Linaclotide — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
