linaclotide · Abbvie · NDA 202811
Linzess
Blocked by patent: US 9708371 (pediatric extension).
FDA has approved 1 generic application (ANDA) for Linzess, though its earliest generic-entry date is 16 Feb 2034 as listed. A generic can be approved before that date when it leaves out a patented use (a section viii carve-out), challenges a patent, or settles with the brand company. An approval is not a launch: cliffwatch does not track launches. Approval is not launch
Listed patents · 7 unexpired
25 Orange Book listing rows for 7 patents, including 7 pediatric extensions. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 9708371 | drug product, use U-1515, U-1516, U-3644, U-4345, U-4566 | 16 Feb 2034 |
| US 9708371 listing row | drug product, use U-1515 | 16 Aug 2033 |
| US 9708371 listing row | drug product, use U-1516 | 16 Aug 2033 |
| US 9708371 listing row | drug product, use U-3644 | 16 Aug 2033 |
| US 9708371 listing row | drug product, use U-4345 | 16 Aug 2033 |
| US 9708371 listing row | drug product, use U-4566 | 16 Aug 2033 |
| US 9708371 listing row | pediatric extension · sets the listed date | 16 Feb 2034 |
| US 8748573 | use U-1515, U-1516, U-4345 | 30 Apr 2032 |
| US 8748573 listing row | use U-1515 | 30 Oct 2031 |
| US 8748573 listing row | use U-1516 | 30 Oct 2031 |
| US 8748573 listing row | use U-4345 | 30 Oct 2031 |
| US 8748573 listing row | pediatric extension | 30 Apr 2032 |
| US 8802628 | drug product | 30 Apr 2032 |
| US 8802628 listing row | drug product | 30 Oct 2031 |
| US 8802628 listing row | pediatric extension | 30 Apr 2032 |
| US 10675325 | drug product | 11 Feb 2032 |
| US 10675325 listing row | drug product | 11 Aug 2031 |
| US 10675325 listing row | pediatric extension | 11 Feb 2032 |
| US 10702576 | use U-1516, U-3644, U-4566 | 11 Feb 2032 |
| US 10702576 listing row | use U-1516 | 11 Aug 2031 |
| US 10702576 listing row | use U-3644 | 11 Aug 2031 |
| US 10702576 listing row | use U-4566 | 11 Aug 2031 |
| US 10702576 listing row | pediatric extension | 11 Feb 2032 |
| US 8933030 | drug product, use U-1516, U-3644, U-4345, U-4566 | 17 Aug 2031 |
| US 8933030 listing row | drug product | 17 Feb 2031 |
| US 8933030 listing row | drug product, use U-1516 | 17 Feb 2031 |
| US 8933030 listing row | drug product, use U-3644 | 17 Feb 2031 |
| US 8933030 listing row | drug product, use U-4345 | 17 Feb 2031 |
| US 8933030 listing row | drug product, use U-4566 | 17 Feb 2031 |
| US 8933030 listing row | pediatric extension | 17 Aug 2031 |
| US 7304036 | pediatric extension | 28 Feb 2027 |
Exclusivities · 2 unexpired
| NPP | new patient population | 21 May 2029 |
| PED | pediatric (6 months added) | 4 May 2029 |
| NPP | new patient population | 4 Nov 2028 |
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
- 25 Oct 2026Generic approved · 202811-00124 Sep 2026
Products covered · 3
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 202811 · 001 · RLD | capsule, oral | 145MCG | 16 Feb 2034 |
| 202811 · 002 · RLD | capsule, oral | 290MCG | 16 Feb 2034 |
| 202811 · 003 · RLD | capsule, oral | 72MCG | 16 Feb 2034 |
Expired or delisted (6)
- US 7304036 · substance, product, use U-1278 · 30 Aug 2026
- US 7304036 · substance, product, use U-4566 · 30 Aug 2026
- US 7304036 · substance, product, use U-1516 · 30 Aug 2026
- US 7304036 · substance, product, use U-4345 · 30 Aug 2026
- US 7304036 · substance, product, use U-3644 · 30 Aug 2026
- I-921 · 12 Jun 2026