Is Apriso still available?

Yes. Apriso (NDA 022301) is listed with marketing status Prescription in the FDA Orange Book.

Does Apriso have a generic?

Yes. The Orange Book lists 35 approved generic (ANDA) applications sharing Apriso's active ingredient (Mesalamine). A generic with an "A"-rated therapeutic-equivalence code is considered substitutable for the brand.

What does Apriso's TE code AB mean?

AB is an "A"-rated therapeutic-equivalence code, meaning the FDA considers Apriso substitutable for its reference brand with no expected difference in clinical effect.

When do Apriso's patents expire?

The FDA Orange Book lists 1 patent against Apriso, with the last listed patent expiring May 01, 2030. A generic launching before a listed patent expires generally must file a Paragraph IV certification.

What is Apriso's FDA application number?

Apriso is approved under NDA 022301, held by Salix.

Orange Book product · Brand (NDA)

Apriso

Mesalamine

Brand (NDA)NDA 022301TE ABRLD Salix

Approved

Oct 31, 2008

Application

Brand (NDA)

TE code

Listed patents

Apriso (Mesalamine) is Salix's brand-name drug, approved by the FDA under NDA 022301 in 2008. It is a reference-listed drug (RLD) — the approved product that generic ANDA applicants must show their version is equivalent to. Its therapeutic-equivalence code is AB, so the FDA considers it substitutable for the reference brand. 35 approved generics share this drug's active ingredient. The FDA Orange Book lists 1 patent against it, the last expiring 2030.

Sourced from the FDA Orange Book

Approval, patents, exclusivity

Key dates

Approval
FDA approval date of this drug product.
Oct 31, 2008
17 yr 11 mo ago
Today
Patent 8865688 expires
Listed method-of-use patent (U-1310) expiration.
May 01, 2030
in 3 yr 10 mo

Protection horizon

Patent & exclusivity timeline

Patent expiryExclusivity endToday

FDA product record

Pharmaceutical detail

Active ingredient

MESALAMINE

Strength

375MG

Dosage form

CAPSULE, EXTENDED RELEASE

Route

ORAL

TE code

Application

NDA 022301

Product number

001

Marketing status

Prescription

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Brand + generics

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

View full Mesalamine family

Orange Book patent file

Listed patents

Listed patents (1)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
8865688	May 01, 2030	in 3 yr 10 mo	U-1310

Apriso — frequently asked questions

Approval, therapeutic equivalence, patents, and exclusivity for this product, from the FDA Orange Book.

Built directly from the FDA Orange Book data file. This product page links back to the Mesalamine active-ingredient family, which is the canonical reference for generics, patents, and exclusivity across all strengths.

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