FDA Orange Book
Generic for Linzess
Linzess contains linaclotide. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Linzess is linaclotide. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 1 of the 3 Linzess products the Orange Book lists.
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Linzess products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 145MCG | Marketed (Rx) | None | 0 | None |
| capsule, oral | 290MCG | Marketed (Rx) | None | 0 | None |
| capsule, oral | 72MCG | Marketed (Rx) | AB | 1 | AB |
NDA 202811, held by ABBVIE INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic linaclotide
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ACTAVIS LABORATORIES FL INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC | 211255 | AB (A-rated, therapeutically equivalent) | September 24, 2026 | 72MCG |
Linzess patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7304036 | August 30, 2026 | Drug substance, Drug product | U-1516 | 202811 |
| 7304036 | August 30, 2026 | Drug substance, Drug product | U-3644 | 202811 |
| 7304036 | August 30, 2026 | Drug substance, Drug product | U-4566 | 202811 |
| 7304036 | August 30, 2026 | Drug substance, Drug product | U-1278 | 202811 |
| 7304036 | August 30, 2026 | Drug substance, Drug product | U-4345 | 202811 |
| 7304036*PED | February 28, 2027 | Method of use | None | 202811 |
| 8933030 | February 17, 2031 | Drug product | U-1516 | 202811 |
| 8933030 | February 17, 2031 | Drug product | U-3644 | 202811 |
| 8933030 | February 17, 2031 | Drug product | U-4566 | 202811 |
| 8933030 | February 17, 2031 | Drug product | U-4345 | 202811 |
| 8933030 | February 17, 2031 | Drug product | None | 202811 |
| 10702576 | August 11, 2031 | Method of use | U-1516 | 202811 |
| 10702576 | August 11, 2031 | Method of use | U-3644 | 202811 |
| 10702576 | August 11, 2031 | Method of use | U-4566 | 202811 |
| 10675325 | August 11, 2031 | Drug product | None | 202811 |
| 8933030*PED | August 17, 2031 | Method of use | None | 202811 |
| 8748573 | October 30, 2031 | Method of use | U-1515 | 202811 |
| 8748573 | October 30, 2031 | Method of use | U-1516 | 202811 |
| 8748573 | October 30, 2031 | Method of use | U-4345 | 202811 |
| 8802628 | October 30, 2031 | Drug product | None | 202811 |
| 10675325*PED | February 11, 2032 | Method of use | None | 202811 |
| 10702576*PED | February 11, 2032 | Method of use | None | 202811 |
| 8802628*PED | April 30, 2032 | Method of use | None | 202811 |
| 8748573*PED | April 30, 2032 | Method of use | None | 202811 |
| 9708371 | August 16, 2033 | Drug product | U-1516 | 202811 |
| 9708371 | August 16, 2033 | Drug product | U-3644 | 202811 |
| 9708371 | August 16, 2033 | Drug product | U-4566 | 202811 |
| 9708371 | August 16, 2033 | Drug product | U-1515 | 202811 |
| 9708371 | August 16, 2033 | Drug product | U-4345 | 202811 |
| 9708371*PED | February 16, 2034 | Method of use | None | 202811 |
Linzess exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| I-921 | New indication | June 12, 2026 | 202811 |
| NPP | New patient population | November 4, 2028 | 202811 |
| PED | Pediatric exclusivity | May 4, 2029 | 202811 |
| NPP | New patient population | May 21, 2029 | 202811 |
Linzess NDC codes
Questions
Is there a generic for Linzess?
Yes. The generic name for Linzess is linaclotide. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 1 of the 3 Linzess products the Orange Book lists.
What is the generic name for Linzess?
The active ingredient in Linzess is linaclotide, per the FDA Orange Book.
When does the Linzess patent expire?
The last patent listed for Linzess in the Orange Book expires February 16, 2034. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.