Details for New Drug Application (NDA): 022309

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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. Eighteen 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	AbbVie Inc.	0051-8462	0051-8462-33	1 BOTTLE, PUMP in 1 CARTON (0051-8462-33) / 88 g in 1 BOTTLE, PUMP
ANDROGEL	testosterone	GEL;TRANSDERMAL	022309	NDA	AbbVie Inc.	0051-8462	0051-8462-33	1 BOTTLE, PUMP in 1 CARTON (0051-8462-33) / 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:	8,466,136	Patent Expiration:	Oct 12, 2026	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	8,466,137	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:	8,466,138	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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Besins Hlthcare	ANDROGEL	testosterone	GEL;TRANSDERMAL	022309-003	Sep 7, 2012	9,125,816*PED	⤷ Subscribe
Besins Hlthcare	ANDROGEL	testosterone	GEL;TRANSDERMAL	022309-002	Sep 7, 2012	6,503,894*PED	⤷ Subscribe
Besins Hlthcare	ANDROGEL	testosterone	GEL, METERED;TRANSDERMAL	022309-001	Apr 29, 2011	6,503,894*PED	⤷ Subscribe
Besins Hlthcare	ANDROGEL	testosterone	GEL;TRANSDERMAL	022309-003	Sep 7, 2012	9,132,089*PED	⤷ Subscribe
Besins Hlthcare	ANDROGEL	testosterone	GEL;TRANSDERMAL	022309-002	Sep 7, 2012	9,132,089*PED	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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