FDA Orange Book · active-ingredient family
Linaclotide
Linaclotide: 1 brand, 2 generics; first approved Aug 30, 2012; generic available.
Generic available5 exclusivity periodsHas discontinued products
Generic status & protection
Generic available: 2 ANDA applications approved.
Earliest patent expiry Latest exclusivity ends
Brands (NDA)
1
Generics (ANDA)
2
Listed patents
14
Next patent expiry
Aug 30, 2026
1 mo ago
Brand (NDA) products
Originator applications
- ABBVIENDA 20281120173 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 145MCG CAPSULE ORAL Rx — 290MCG CAPSULE ORAL Rx — 72MCG CAPSULE ORAL Rx —
Generic (ANDA) products (2)
Abbreviated applications
- LINACLOTIDEAUROBINDO PHARMAANDA 20961120232 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 145MCG CAPSULE ORAL Discontinued — 290MCG CAPSULE ORAL Discontinued — - LINACLOTIDEMYLANANDA 20956420212 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 145MCG CAPSULE ORAL Discontinued — 290MCG CAPSULE ORAL Discontinued —
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Marketing exclusivity
Hatch-Waxman
- I-921New indication exclusivity (3 years)
4 mo ago
- NPPNew patient population exclusivity (3 years)
in 2 yr 8 mo
- I-921New indication exclusivity (3 years)
4 mo ago
- NPPNew patient population exclusivity (3 years)
in 2 yr 1 mo
- PEDPediatric exclusivity (adds 6 months)
in 2 yr 7 mo
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 7304036 | 1 mo ago | SubstanceProductU-1516 | |
| 7304036*PED | in 5 mo | ||
| 8933030 | in 4 yr 5 mo | ProductU-1516 | |
| 10702576 | in 4 yr 11 mo | U-1516 | |
| 10675325 | in 4 yr 11 mo | Product | |
| 8933030*PED | in 4 yr 11 mo | ||
| 8748573 | in 5 yr 1 mo | U-1515 | |
| 8802628 | in 5 yr 1 mo | Product | |
| 10675325*PED | in 5 yr 5 mo | ||
| 10702576*PED | in 5 yr 5 mo | ||
| 8802628*PED | in 5 yr 8 mo | ||
| 8748573*PED | in 5 yr 8 mo | ||
| 9708371 | in 6 yr 11 mo | ProductU-1516 | |
| 9708371*PED | in 7 yr 5 mo |
Approval history
FDA approval span
First approval
14 yr 4 mo ago
Most recent approval
3 yr 9 mo ago
Approvals span 2012–2023 across 3 FDA applications.
Brand (NDA) 133%
Generic (ANDA) 267%
Linaclotide: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
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