AndroGel Patent Timeline and Generic Availability: What Patients and Clinicians Need to Know

What the AndroGel FDA record lists

Drugs@FDA lists NDA 021015 under Besins HealthCare, with an original approval date of February 28, 2000, classified as a type 3 new dosage form and reviewed on the standard track [1]. Three presentations appear: 25 mg/2.5 g packets, 50 mg/5 g packets, and a 12.5 mg/1.25 g metered pump [1]. Each carries therapeutic equivalence (TE) code AB1, and AndroGel is marked as a reference listed drug [1]. The most recent labeling supplement listed is SUPPL-47, dated July 11, 2025 [1].

That is an approval and labeling history. It is not a patent timeline: the record contains no patent numbers, expiry dates, Paragraph IV certifications, settlement terms or generic approval entries [1].

Is a generic testosterone gel 1% available?

The FDA record for AndroGel does not say. The AB1 code and the reference-listed-drug mark are separate fields describing AndroGel's own presentations, and neither one shows that a generic is on the market [1]. No generic approval date or launch date appears in the record [1].

NDA 022504 is Axiron, not AndroGel 1.62%

Drugs@FDA lists NDA 022504 as Axiron, a metered testosterone solution from Eli Lilly, approved November 23, 2010 and listed as discontinued [2]. It is a different product from AndroGel 1.62%, so its approval date does not belong on an AndroGel timeline.

A June 2026 labeling request is not a patent or generic date

In June 2026 FDA requested label updates for testosterone products, including removing the limitation of use stating that safety and efficacy in age-related hypogonadism have not been established, and revising prostate cancer and benign prostatic hyperplasia safety information [3]. FDA also said the TRAVERSE results did not demonstrate a new safety signal or trend in adverse cardiovascular outcomes [3]. These are labeling decisions covering testosterone products generally, not patent expiries or dates of generic entry.