Is there a generic for Linaclotide?

Yes. The FDA Orange Book lists 2 approved generic (ANDA) applications for Linaclotide, referencing the brand LINZESS. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Linaclotide?

LINZESS (NDA 202811, ABBVIE) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What patents protect Linaclotide?

The Orange Book lists 14 patents against Linaclotide products, with the earliest listed expiry in 2026. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

Does Linaclotide have FDA marketing exclusivity?

Yes. The Orange Book records 4 marketing-exclusivity periods for Linaclotide. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

What dosage forms of Linaclotide are approved?

Linaclotide is approved in the following dosage form: capsule.

FDA Orange Book · active-ingredient family

Linaclotide

Linaclotide: 1 brand, 2 generics; first approved Aug 30, 2012; generic available.

Generic available4 exclusivity periodsHas discontinued products

Generic status & protection

Generic available: 2 ANDA applications approved.

Earliest patent expiry Aug 30, 2026Latest exclusivity ends May 21, 2029

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Aug 30, 2026

2 mo ago

Brand (NDA) products

Originator applications

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LINZESSRLDRS
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 -

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

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LINACLOTIDE
AUROBINDO PHARMAANDA 20961120232 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
145MCG CAPSULE ORAL Discontinued -
290MCG CAPSULE ORAL Discontinued -
LINACLOTIDE
MYLANANDA 20956420212 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
145MCG CAPSULE ORAL Discontinued -
290MCG CAPSULE ORAL Discontinued -

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
145MCG	CAPSULE	ORAL	Discontinued	-
290MCG	CAPSULE	ORAL	Discontinued	-

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

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Patent expiryExclusivity endToday

Marketing exclusivity

Hatch-Waxman

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I-921New indication exclusivity (3 years)
Jun 12, 2026
4 mo ago
NPPNew patient population exclusivity (3 years)
Nov 04, 2028
in 2 yr 1 mo
PEDPediatric exclusivity (adds 6 months)
May 04, 2029
in 2 yr 7 mo
NPPNew patient population exclusivity (3 years)
May 21, 2029
in 2 yr 7 mo

Listed patents

Orange Book patent file

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Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
7304036	Aug 30, 2026	2 mo ago	SubstanceProductU-1516
7304036*PED	Feb 28, 2027	in 4 mo
8933030	Feb 17, 2031	in 4 yr 5 mo	ProductU-1516
10702576	Aug 11, 2031	in 4 yr 10 mo	U-1516
10675325	Aug 11, 2031	in 4 yr 10 mo	Product
8933030*PED	Aug 17, 2031	in 4 yr 11 mo
8748573	Oct 30, 2031	in 5 yr 1 mo	U-1515
8802628	Oct 30, 2031	in 5 yr 1 mo	Product
10675325*PED	Feb 11, 2032	in 5 yr 5 mo
10702576*PED	Feb 11, 2032	in 5 yr 5 mo
8802628*PED	Apr 30, 2032	in 5 yr 7 mo
8748573*PED	Apr 30, 2032	in 5 yr 7 mo
9708371	Aug 16, 2033	in 6 yr 11 mo	ProductU-1516
9708371*PED	Feb 16, 2034	in 7 yr 5 mo

Approval history

FDA approval span

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First approval

Aug 30, 2012

14 yr 4 mo ago

Most recent approval

Feb 07, 2023

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

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