Last Updated: September 24, 2026

Details for New Drug Application (NDA): 205488

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NDA 205488 describes NATESTO, which is a drug marketed by Acerus and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the NATESTO profile page.

The generic ingredient in NATESTO is testosterone. There is one drug master file entry for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the testosterone profile page.

Summary for 205488

Tradename:	NATESTO
Applicant:	Acerus
Ingredient:	testosterone
Patents:	2

Pharmacology for NDA: 205488

Mechanism of Action	Androgen Receptor Agonists

Medical Subject Heading (MeSH) Categories for 205488

Androgens

Suppliers and Packaging for NDA: 205488

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NATESTO	testosterone	GEL, METERED;NASAL	205488	NDA	Acerus Pharmaceuticals Corporation	42667-5511	42667-5511-1	1 APPLICATOR in 1 BOX (42667-5511-1) / 11 g in 1 APPLICATOR

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	GEL, METERED;NASAL			Strength	5.5MG/0.122GM ACTUATION
Approval Date:	May 28, 2014	TE:		RLD:	Yes
Patent:	⤷ Start Trial	Patent Expiration:	Mar 17, 2034	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	NASAL ADMINISTRATION OF A TESTOSTERONE GEL TO A PATIENT TO TREAT THE PATIENT FOR A CONDITION ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE
Patent:	⤷ Start Trial	Patent Expiration:	Mar 17, 2034	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATING HYPOGONADOTROPIC HYPOGONADISM BY ADMINISTERING TO A MALE WITH ALLERGIC OR SEASONAL RHINITIS 5.5MG TESTOSTERONE IN 0.122G TESTOSTERONE GEL IN EACH NOSTRIL 3 TIMES DAILY VIA A METERED DOSE PUMP ACTUATABLE 60 TIMES AND CONTAINING 11 G GEL
Patent:	⤷ Start Trial	Patent Expiration:	Mar 17, 2034	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATING PRIMARY HYPOGONADISM BY ADMINISTERING TO A MALE WITH ALLERGIC OR SEASONAL RHINITIS 5.5MG TESTOSTERONE IN 0.122G TESTOSTERONE GEL IN EACH NOSTRIL 3 TIMES DAILY VIA A METERED DOSE PUMP ACTUATABLE 60 TIMES AND CONTAINING 11 G GEL

Expired US Patents for NDA 205488

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Acerus	NATESTO	testosterone	GEL, METERED;NASAL	205488-001	May 28, 2014	⤷ Start Trial	⤷ Start Trial
Acerus	NATESTO	testosterone	GEL, METERED;NASAL	205488-001	May 28, 2014	⤷ Start Trial	⤷ Start Trial
Acerus	NATESTO	testosterone	GEL, METERED;NASAL	205488-001	May 28, 2014	⤷ Start Trial	⤷ Start Trial
Acerus	NATESTO	testosterone	GEL, METERED;NASAL	205488-001	May 28, 2014	⤷ Start Trial	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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