No generic version of Linzess (linaclotide) is available in the United States yet, and under the patent settlements reached between 2018 and 2020, the earliest a generic release date can occur is March 31, 2029, when Teva is licensed to launch generic versions of the 145 mcg and 290 mcg capsules. Other generic makers are licensed to enter later, in 2030 and 2031, and the 72 mcg strength is on a separate, later timeline.1Drugs.com. Generic Linzess Availability
Licensed Generic Entry Dates
Ironwood Pharmaceuticals and Allergan (now part of AbbVie) settled patent infringement suits with five generic drugmakers. Each settlement grants a license to sell a generic version of Linzess starting on a specified date, subject to FDA approval:
- Teva: March 31, 2029, for 145 mcg and 290 mcg only. Teva has no license for the 72 mcg dose.2Ironwood Pharmaceuticals. Ironwood and Allergan Announce Settlement With Teva Resolving Linzess Patent Litigation
- Sandoz: February 5, 2030, for 145 mcg and 290 mcg.3Ironwood Pharmaceuticals. Ironwood and Allergan Announce Settlement Resolving Linzess Patent Litigation
- Mylan: February 5, 2030, for 145 mcg and 290 mcg, and August 5, 2030, for 72 mcg.4Ironwood Pharmaceuticals. Ironwood and Allergan Announce Settlement With Mylan Resolving Linzess Patent Litigation
- Aurobindo Pharma: August 5, 2030.5Ironwood Pharmaceuticals. Ironwood and Allergan Announce Settlement With Aurobindo Pharma Resolving Linzess Patent Litigation
- Sun Pharmaceutical Industries: February 1, 2031.6Sun Pharma. Press Release – Settlement of Patent Litigation for Generic Linzess
Teva sits alone in 2029. The next wave, in early 2030, opens the market to Sandoz and Mylan on the two higher-dose strengths. By the following year, all five licensed generics can be on the shelf, assuming each has cleared FDA approval by then.
Why the Wait Runs to 2029 and Beyond
Linzess is covered by a stack of Orange Book patents that expire at different times. The earliest patents began expiring in January 2024, and a key drug-substance patent (U.S. Patent No. 7,304,036) expires on August 30, 2026. But later formulation and methods-of-use patents run much longer: U.S. Patent Nos. 8,748,573 and 8,802,628, which cover the stable capsule formulation, expire in October 2031, and U.S. Patent No. 9,708,371 does not expire until August 2033.7FDA. ANDA Approval Letter for Linzess
The settlement dates fall between those earlier and later expirations. Rather than litigating the later patents to judgment, each generic company accepted a licensed launch date years before those patents expire but well after the core compound patent runs out.
The 72 mcg Dose Is on a Separate Track
The lowest-strength 72 mcg capsule has fewer generic licenses tied to it and a later earliest date. Teva’s 2029 license does not cover 72 mcg. The Delaware court had previously dismissed without prejudice the litigation over Teva’s 72 mcg version after Teva stipulated to infringement of certain patent claims that expire in 2026, subject to a possible pediatric extension.
Two additional patents granted in mid-2020, U.S. Patent Nos. 10,675,325 and 10,702,576, cover stable formulations particularly relevant to the 72 mcg dose and expire in August 2031 before any pediatric extensions.8PubChem. US-10675325-B2 Among the licensed generics, only Mylan has a settlement date specifically for the 72 mcg strength: August 5, 2030.
Conditions Attached to Every Date
None of the settlement dates guarantee that a generic will actually appear on that day. Every license is subject to FDA approval of the generic company’s Abbreviated New Drug Application. A company that has not obtained approval by its licensed date cannot launch on that date.
Each settlement also includes limited customary provisions that can move the launch date earlier under certain circumstances. Those provisions are set out in confidential agreements and have not been made public in detail. The practical effect is that the dates above are ceilings rather than fixed launch days: a generic could come slightly sooner under an acceleration trigger, or later if FDA approval is delayed.
Where Things Stand Now
As of mid-2026, no generic version of Linzess has been approved by the FDA, and the drug remains under patent protection.1Drugs.com. Generic Linzess Availability Ironwood continues to co-commercialize Linzess with AbbVie. For anyone tracking when a lower-cost generic might be filled at the pharmacy, the calendar to watch is March 31, 2029, for the 145 mcg and 290 mcg strengths, and later dates in 2030 for the 72 mcg strength, always contingent on FDA approval.