natesto Drug Patent Profile
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Which patents cover Natesto, and when can generic versions of Natesto launch?
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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Questions you can ask:
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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 |
Acerus Pharmaceutical | Phase 4 |
University of Florida | 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 | |
Saudi Arabia | 04250363 | نظام توصيل للإطلاق المتحكم به لهرمونات جنسية للاستخدام عن طريق الأنف (Controlled release delivery sustem of sexual hormones for nasal application) | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |