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Last Updated: June 29, 2022

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 twenty-nine patent family members in twenty-one countries.

The generic ingredient in NATESTO is testosterone. There are sixty-nine drug master file entries for this compound. Twenty-one 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 27th, 2006.

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Summary for NATESTO
Drug patent expirations by year for NATESTO
Drug Prices for NATESTO

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Recent Clinical Trials for NATESTO

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

SponsorPhase
University of FloridaPhase 4
Acerus PharmaceuticalPhase 4
Baylor College of MedicineEarly Phase 1

See all NATESTO clinical trials

Pharmacology for NATESTO
Drug Class Androgen
Mechanism of ActionAndrogen Receptor Agonists

US Patents and Regulatory Information for NATESTO

NATESTO is protected by five US patents.

Patents protecting NATESTO


Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Controlled release delivery system for nasal applications and methods of treatment
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Controlled release delivery system for nasal applications and method of treatment
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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

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

EU/EMA Drug Approvals for NATESTO

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.

Country Patent Number Title Estimated Expiration
Croatia P20060147 CONTROLLED RELEASE DELIVERY SYSTEM FOR NASAL APPLICATIONS See Plans and Pricing
Slovenia 1530965 See Plans and Pricing
Poland 379867 Układ dostarczania o kontrolowanym uwalnianiu do podawania donosowego (CONTROLLED RELEASE DELIVERY SYSTEM FOR NASAL APPLICATIONS) See Plans and Pricing
World Intellectual Property Organization (WIPO) 2005044273 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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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. 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.