Is Akten still available?

Yes. Akten (NDA 022221) is listed with marketing status Prescription in the FDA Orange Book.

Does Akten have a generic?

Yes. The Orange Book lists 47 approved generic (ANDA) applications sharing Akten's active ingredient (Lidocaine Hydrochloride). A generic with an "A"-rated therapeutic-equivalence code is considered substitutable for the brand.

When do Akten's patents expire?

The FDA Orange Book lists 1 patent against Akten, with the last listed patent expiring Jul 24, 2026. A generic launching before a listed patent expires generally must file a Paragraph IV certification.

What is Akten's FDA application number?

Akten is approved under NDA 022221, held by Thea Pharma.

Orange Book product · Brand (NDA)

Akten

Lidocaine Hydrochloride

Brand (NDA)NDA 022221RLD Thea Pharma

Approved

Oct 07, 2008

Application

Brand (NDA)

TE code

Not listed

Listed patents

Akten (Lidocaine Hydrochloride) is Thea Pharma's brand-name drug, approved by the FDA under NDA 022221 in 2008. It is a reference-listed drug (RLD) — the approved product that generic ANDA applicants must show their version is equivalent to. 47 approved generics share this drug's active ingredient. The FDA Orange Book lists 1 patent against it, the last expiring 2026.

Sourced from the FDA Orange Book

Approval, patents, exclusivity

Key dates

Approval
FDA approval date of this drug product.
Oct 07, 2008
18 yr ago
Today
Patent 8759401 expires
Listed drug product patent expiration.
Jul 24, 2026
in 11 d

Protection horizon

Patent & exclusivity timeline

Patent expiryExclusivity endToday

FDA product record

Pharmaceutical detail

Active ingredient

LIDOCAINE HYDROCHLORIDE

Strength

3.5%

Dosage form

GEL

Route

OPHTHALMIC

TE code

Not listed

Application

NDA 022221

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 Lidocaine Hydrochloride 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
8759401	Jul 24, 2026	in 11 d	ProductU-1523

Akten — 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 Lidocaine Hydrochloride active-ingredient family, which is the canonical reference for generics, patents, and exclusivity across all strengths.

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