AXIRON Drug Patent Profile
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When do Axiron patents expire, and when can generic versions of Axiron launch?
Axiron is a drug marketed by Eli Lilly And Co and is included in one NDA. There are six patents protecting this drug and one Paragraph IV challenge.
This drug has thirty-seven patent family members in fifteen countries.
The generic ingredient in AXIRON 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 Axiron
A generic version of AXIRON was approved as testosterone by ACTAVIS LABS UT INC on January 27th, 2006.
Summary for AXIRON
International Patents: | 37 |
US Patents: | 6 |
Applicants: | 1 |
NDAs: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 73 |
Clinical Trials: | 9 |
Patent Applications: | 7,160 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for AXIRON |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for AXIRON |
What excipients (inactive ingredients) are in AXIRON? | AXIRON excipients list |
DailyMed Link: | AXIRON at DailyMed |
Recent Clinical Trials for AXIRON
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Syneos Health | Phase 3 |
INC Research | Phase 3 |
Clarus Therapeutics, Inc. | Phase 3 |
Anatomical Therapeutic Chemical (ATC) Classes for AXIRON
Paragraph IV (Patent) Challenges for AXIRON
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
AXIRON | Topical Solution | testosterone | 30 mg/1.5 mL | 022504 | 1 | 2013-01-29 |
US Patents and Regulatory Information for AXIRON
AXIRON is protected by six US patents.
Patents protecting AXIRON
Spreading implement
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: A METHOD OF INCREASING THE TESTOSTERONE BLOOD LEVEL OF A PERSON IN NEED THEREOF
Method and composition for transdermal drug delivery
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: A METHOD OF INCREASING THE TESTOSTERONE BLOOD LEVEL OF AN ADULT MALE SUBJECT IN NEED THEREOF
Spreading implement
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: A METHOD OF TRANSDERMAL ADMINISTRATION OF A PHYSIOLOGICALLY ACTIVE AGENT TO A SUBJECT.
Method and composition for transdermal drug delivery
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: A METHOD OF INCREASING THE TESTOSTERONE BLOOD LEVEL OF AN ADULT MALE SUBJECT IN NEED THEREOF
Method and composition for transdermal drug delivery
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: A METHOD OF INCREASING THE TESTOSTERONE BLOOD LEVEL OF AN ADULT MALE SUBJECT IN NEED THEREOF
Spreading implement
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: A METHOD OF INCREASING THE TESTOSTERONE BLOOD LEVEL OF AN ADULT MALE SUBJECT IN NEED THEREOF
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Eli Lilly And Co | AXIRON | testosterone | SOLUTION, METERED;TRANSDERMAL | 022504-001 | Nov 23, 2010 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Eli Lilly And Co | AXIRON | testosterone | SOLUTION, METERED;TRANSDERMAL | 022504-001 | Nov 23, 2010 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Eli Lilly And Co | AXIRON | testosterone | SOLUTION, METERED;TRANSDERMAL | 022504-001 | Nov 23, 2010 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Eli Lilly And Co | AXIRON | testosterone | SOLUTION, METERED;TRANSDERMAL | 022504-001 | Nov 23, 2010 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Eli Lilly And Co | AXIRON | testosterone | SOLUTION, METERED;TRANSDERMAL | 022504-001 | Nov 23, 2010 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Eli Lilly And Co | AXIRON | testosterone | SOLUTION, METERED;TRANSDERMAL | 022504-001 | Nov 23, 2010 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
>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 AXIRON
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Eli Lilly And Co | AXIRON | testosterone | SOLUTION, METERED;TRANSDERMAL | 022504-001 | Nov 23, 2010 | ⤷ Try a Trial | ⤷ Try a Trial |
Eli Lilly And Co | AXIRON | testosterone | SOLUTION, METERED;TRANSDERMAL | 022504-001 | Nov 23, 2010 | ⤷ Try a Trial | ⤷ Try a Trial |
Eli Lilly And Co | AXIRON | testosterone | SOLUTION, METERED;TRANSDERMAL | 022504-001 | Nov 23, 2010 | ⤷ Try a Trial | ⤷ Try a Trial |
Eli Lilly And Co | AXIRON | testosterone | SOLUTION, METERED;TRANSDERMAL | 022504-001 | Nov 23, 2010 | ⤷ Try a Trial | ⤷ Try a Trial |
Eli Lilly And Co | AXIRON | testosterone | SOLUTION, METERED;TRANSDERMAL | 022504-001 | Nov 23, 2010 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for AXIRON
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 AXIRON
See the table below for patents covering AXIRON around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Eurasian Patent Organization | 200500084 | ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ ДЛЯ ЧРЕСКОЖНОЙ ДОСТАВКИ АКТИВНОГО АГЕНТА | ⤷ Try a Trial |
Japan | 4213211 | ⤷ Try a Trial | |
Canada | 2674661 | INSTRUMENT D'ETALEMENT (SPREADING IMPLEMENT) | ⤷ Try a Trial |
Luxembourg | 91973 | ⤷ Try a Trial | |
World Intellectual Property Organization (WIPO) | 2004000263 | ⤷ Try a Trial | |
Spain | 2348313 | ⤷ Try a Trial | |
Brazil | 0312007 | Controle de taxa de administração transcutânea usando composições farmacêuticas amorfas | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for AXIRON
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1769785 | 91971 | Luxembourg | ⤷ Try a Trial | 91971, EXPIRES: 20220219 |
1769785 | C300521 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: FENTANYL; REG NO/DATE: EU/2/11/127/001 20111006 |
0901368 | C300523 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: FENTANYL; REGISTRATION NO/DATE: EU/2/11/127/001 20111006 |
0901368 | 91973 | Luxembourg | ⤷ Try a Trial | 91973, EXPIRES: 20220219 |
1769785 | CA 2012 00012 | Denmark | ⤷ Try a Trial | |
1769785 | CA 2012 00011 | Denmark | ⤷ Try a Trial | |
1769785 | C300522 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: FENTANYL EN DOSERINGSAPPLICATOR; REG. NO/DATE: EU/2/11/127/001 20111006 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |