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 27th, 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 |
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 |
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
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Controlled release delivery system for nasal applications and methods of treatment
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Controlled release delivery system for nasal applications and method of treatment
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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 | 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 | ||||
| Acerus | NATESTO | testosterone | GEL, METERED;NASAL | 205488-001 | May 28, 2014 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Acerus | NATESTO | testosterone | GEL, METERED;NASAL | 205488-001 | May 28, 2014 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ 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
| 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 |
| 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
| 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 |
|---|---|---|---|
| European Patent Office | 1530965 | Composition à liberation prolongée pour application nasale comprenant des hormones sexuelles (Controlled release delivery system of sexual hormones for nasal application) | ⤷ Sign Up |
| Austria | E319426 | ⤷ Sign Up | |
| Malaysia | 131483 | CONTROLLED RELEASE DELIVERY SYSTEM OF SEXUAL HORMONES FOR NASAL APPLICATIONS | ⤷ Sign Up |
| South Korea | 100861443 | ⤷ Sign Up | |
| Denmark | 1530965 | ⤷ Sign Up | |
| World Intellectual Property Organization (WIPO) | 2014080283 | ⤷ Sign Up | |
| >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.
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