NATESTO Drug Patent Profile

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Which patents cover Natesto, and what generic alternatives are available?

Natesto is a drug marketed by Acerus and is included in one NDA. There are five patents protecting this drug.

This drug has thirty-one patent family members in twenty-two countries.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Natesto

A generic version of NATESTO was approved as testosterone by ACTAVIS LABS UT INC on January 27^th, 2006.

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Summary for NATESTO

International Patents:	31
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	73
Clinical Trials:	9
Patent Applications:	4,308
Drug Prices:	Drug price information for NATESTO
What excipients (inactive ingredients) are in NATESTO?	NATESTO excipients list
DailyMed Link:	NATESTO at DailyMed

Drug patent expirations by year for NATESTO

Recent Clinical Trials for NATESTO

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Southern California College of Optometry at Marshall B. Ketchum University	Phase 2
University of Florida	Phase 4
Acerus Pharmaceutical	Phase 4

See all NATESTO clinical trials

Pharmacology for NATESTO

Drug Class	Androgen
Mechanism of Action	Androgen Receptor Agonists

US Patents and Regulatory Information for NATESTO

NATESTO is protected by five US patents.

Patents protecting NATESTO

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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

Controlled release delivery system for nasal applications
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Controlled release delivery system for nasal applications and methods of treatment
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Controlled release delivery system for nasal applications and method of treatment
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Patented Use: A METHOD OF TESTOSTERONE REPLACEMENT THERAPY COMPRISING THE STEP OF NASALLY ADMINISTERING TO A PATIENT IN NEED OF SUCH TREATMENT AN EFFECTIVE AMOUNT OF TESTOSTERONE GEL FORMULATION.

Controlled release delivery system for nasal applications
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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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Acerus	NATESTO	testosterone	GEL, METERED;NASAL	205488-001	May 28, 2014		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Acerus	NATESTO	testosterone	GEL, METERED;NASAL	205488-001	May 28, 2014		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Acerus	NATESTO	testosterone	GEL, METERED;NASAL	205488-001	May 28, 2014		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for NATESTO

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

EU/EMA Drug Approvals for NATESTO

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Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Warner Chilcott UK Ltd.	Intrinsa	testosterone	EMEA/H/C/000634 Intrinsa is indicated for the treatment of hypoactive sexual desire disorder (HSDD) in bilaterally oophorectomised and hysterectomised (surgically induced menopause) women receiving concomitant estrogen therapy.	Withdrawn	no	no	no	2006-07-28
Warner Chilcott Deutschland GmbH	Livensa	testosterone	EMEA/H/C/000630 Livensa is indicated for the treatment of hypoactive sexual desire disorder (HSDD) in bilaterally oophorectomised and hysterectomised (surgically induced menopause) women receiving concomitant estrogen therapy.	Withdrawn	no	no	no	2006-07-28
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for NATESTO

See the table below for patents covering NATESTO around the world.

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Country	Patent Number	Title	Estimated Expiration
Austria	319426		⤷ Sign Up
Canada	2541498	SYSTEME D'ADMINISTRATION A LIBERATION CONTROLEE POUR APPLICATIONS NASALES (CONTROLLED RELEASE DELIVERY SYSTEM FOR NASAL APPLICATIONS)	⤷ Sign Up
Taiwan	I350176		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration