Is Acular Ls still available?

Yes. Acular Ls (NDA 021528) is listed with marketing status Prescription in the FDA Orange Book.

Does Acular Ls have a generic?

Yes. The Orange Book lists 45 approved generic (ANDA) applications sharing Acular Ls's active ingredient (Ketorolac Tromethamine). A generic with an "A"-rated therapeutic-equivalence code is considered substitutable for the brand.

When do Acular Ls's patents expire?

The FDA Orange Book lists 2 patents against Acular Ls, with the last listed patent expiring Nov 24, 2027. A generic launching before a listed patent expires generally must file a Paragraph IV certification.

What is Acular Ls's FDA application number?

Acular Ls is approved under NDA 021528, held by Abbvie.

Orange Book product · Brand (NDA)

Acular Ls

Ketorolac Tromethamine

Brand (NDA)NDA 021528RLD Abbvie

Approved

May 30, 2003

Application

Brand (NDA)

TE code

Not listed

Listed patents

Acular Ls (Ketorolac Tromethamine) is Abbvie's brand-name drug, approved by the FDA under NDA 021528 in 2003. It is a reference-listed drug (RLD) — the approved product that generic ANDA applicants must show their version is equivalent to. 45 approved generics share this drug's active ingredient. The FDA Orange Book lists 2 patents against it, the last expiring 2027.

Sourced from the FDA Orange Book

Approval, patents, exclusivity

Key dates

Approval
FDA approval date of this drug product.
May 30, 2003
23 yr 5 mo ago
Today
Patent 8008338 expires
Listed drug substance patent expiration.
May 24, 2027
in 11 mo
Patent 8008338*PED expires
Listed listed patent expiration.
Nov 24, 2027
in 1 yr 5 mo

Protection horizon

Patent & exclusivity timeline

Patent expiryExclusivity endToday

FDA product record

Pharmaceutical detail

Active ingredient

KETOROLAC TROMETHAMINE

Strength

0.4%

Dosage form

SOLUTION/DROPS

Route

OPHTHALMIC

TE code

Not listed

Application

NDA 021528

Product number

001

Marketing status

Prescription

Reference listed drug (RLD)

Yes

Reference standard (RS)

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 Ketorolac Tromethamine family

Orange Book patent file

Listed patents

Listed patents (2)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
8008338	May 24, 2027	in 11 mo	SubstanceProductU-1181
8008338*PED	Nov 24, 2027	in 1 yr 5 mo

Acular Ls — 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 Ketorolac Tromethamine active-ingredient family, which is the canonical reference for generics, patents, and exclusivity across all strengths.

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