You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: December 14, 2025

Details for New Drug Application (NDA): 022309

✉ Email this page to a colleague

NDA 022309 describes ANDROGEL, which is a drug marketed by Besins Hlthcare and is included in two NDAs. It is available from two suppliers. There are eight patents protecting this drug and three Paragraph IV challenges. Additional details are available on the ANDROGEL profile page.

The generic ingredient in ANDROGEL is testosterone. There are sixty-nine drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the testosterone profile page.

Summary for 022309

Tradename:	ANDROGEL
Applicant:	Besins Hlthcare
Ingredient:	testosterone
Patents:	8

Pharmacology for NDA: 022309

Mechanism of Action	Androgen Receptor Agonists

Medical Subject Heading (MeSH) Categories for 022309

Androgens

Suppliers and Packaging for NDA: 022309

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ANDROGEL	testosterone	GEL, METERED;TRANSDERMAL	022309	NDA	ASCEND Therapeutics U.S., LLC	17139-562	17139-562-88	1 BOTTLE, PUMP in 1 CARTON (17139-562-88) / 88 g in 1 BOTTLE, PUMP
ANDROGEL	testosterone	GEL;TRANSDERMAL	022309	NDA	ASCEND Therapeutics U.S., LLC	17139-562	17139-562-88	1 BOTTLE, PUMP in 1 CARTON (17139-562-88) / 88 g in 1 BOTTLE, PUMP

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	GEL, METERED;TRANSDERMAL			Strength	1.62% (20.25MG/1.25GM ACTUATION)
Approval Date:	Apr 29, 2011	TE:	AB	RLD:	Yes
Patent:	⤷ Get Started Free	Patent Expiration:	Oct 12, 2026	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Get Started Free	Patent Expiration:	Oct 12, 2026	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE
Patent:	⤷ Get Started Free	Patent Expiration:	Oct 12, 2026	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE

Expired US Patents for NDA 022309

Subscribe to access the full database, or Get Started Free
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Besins Hlthcare	ANDROGEL	testosterone	GEL, METERED;TRANSDERMAL	022309-001	Apr 29, 2011	⤷ Get Started Free	⤷ Get Started Free
Besins Hlthcare	ANDROGEL	testosterone	GEL;TRANSDERMAL	022309-003	Sep 7, 2012	⤷ Get Started Free	⤷ Get Started Free
Besins Hlthcare	ANDROGEL	testosterone	GEL;TRANSDERMAL	022309-002	Sep 7, 2012	⤷ Get Started Free	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.