axiron Drug Patent Profile
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Which patents cover Axiron, and what generic alternatives are available?
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. Nineteen 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.
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Summary for axiron
| International Patents: | 37 |
| US Patents: | 6 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 73 |
| Clinical Trials: | 9 |
| Patent Applications: | 6,377 |
| 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 |
|---|---|
| INC Research | Phase 3 |
| Clarus Therapeutics, Inc. | Phase 3 |
| Syneos Health | Phase 3 |
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
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Patented Use: A METHOD OF INCREASING THE TESTOSTERONE BLOOD LEVEL OF A PERSON IN NEED THEREOF
Method and composition for transdermal drug delivery
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Patented Use: A METHOD OF INCREASING THE TESTOSTERONE BLOOD LEVEL OF AN ADULT MALE SUBJECT IN NEED THEREOF
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Patented Use: A METHOD OF TRANSDERMAL ADMINISTRATION OF A PHYSIOLOGICALLY ACTIVE AGENT TO A SUBJECT.
Method and composition for transdermal drug delivery
Patent Number: ⤷ Sign Up
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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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: A METHOD OF INCREASING THE TESTOSTERONE BLOOD LEVEL OF AN ADULT MALE SUBJECT IN NEED THEREOF
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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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Eli Lilly And Co | AXIRON | testosterone | SOLUTION, METERED;TRANSDERMAL | 022504-001 | Nov 23, 2010 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Eli Lilly And Co | AXIRON | testosterone | SOLUTION, METERED;TRANSDERMAL | 022504-001 | Nov 23, 2010 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Eli Lilly And Co | AXIRON | testosterone | SOLUTION, METERED;TRANSDERMAL | 022504-001 | Nov 23, 2010 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Eli Lilly And Co | AXIRON | testosterone | SOLUTION, METERED;TRANSDERMAL | 022504-001 | Nov 23, 2010 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Eli Lilly And Co | AXIRON | testosterone | SOLUTION, METERED;TRANSDERMAL | 022504-001 | Nov 23, 2010 | DISCN | Yes | No | ⤷ 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 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 | ⤷ Sign Up | ⤷ Sign Up |
| Eli Lilly And Co | AXIRON | testosterone | SOLUTION, METERED;TRANSDERMAL | 022504-001 | Nov 23, 2010 | ⤷ Sign Up | ⤷ Sign Up |
| Eli Lilly And Co | AXIRON | testosterone | SOLUTION, METERED;TRANSDERMAL | 022504-001 | Nov 23, 2010 | ⤷ Sign Up | ⤷ Sign Up |
| Eli Lilly And Co | AXIRON | testosterone | SOLUTION, METERED;TRANSDERMAL | 022504-001 | Nov 23, 2010 | ⤷ Sign Up | ⤷ Sign Up |
| Eli Lilly And Co | AXIRON | testosterone | SOLUTION, METERED;TRANSDERMAL | 022504-001 | Nov 23, 2010 | ⤷ Sign Up | ⤷ Sign Up |
| >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 |
|---|---|---|---|
| Hong Kong | 1101553 | ⤷ Sign Up | |
| Australia | 1713497 | ⤷ Sign Up | |
| European Patent Office | 0901368 | PROMOTEURS DE PENETRATION DERMIQUE ET SYSTEME D'ADMINISTRATION DE MEDICAMENTS COMPRENANT CES PROMOTEURS (DERMAL PENETRATION ENHANCERS AND DRUG DELIVERY SYSTEMS INVOLVING SAME) | ⤷ Sign Up |
| Hong Kong | 1077192 | 使用無定形藥物組合物對經皮傳輸速率的控制 (TRANSDERMAL DELIVERY RATE CONTROL USING AMORPHOUS PHARMACEUTICAL COMPOSITIONS) | ⤷ Sign Up |
| Japan | 5114496 | ⤷ Sign Up | |
| European Patent Office | 1896038 | METHODE ET COMPOSITION POUR L'ADMINISTRATION TRANSDERMIQUE DE LA TESTOSTERONE (METHOD AND COMPOSITION FOR TESTOSTERONE TRANSDERMAL DELIVERY) | ⤷ Sign Up |
| World Intellectual Property Organization (WIPO) | 2008083423 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for axiron
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1769785 | C300522 | Netherlands | ⤷ Sign Up | PRODUCT NAME: FENTANYL EN DOSERINGSAPPLICATOR; REG. NO/DATE: EU/2/11/127/001 20111006 |
| 1769785 | 91971 | Luxembourg | ⤷ Sign Up | 91971, EXPIRES: 20220219 |
| 0901368 | 91973 | Luxembourg | ⤷ Sign Up | 91973, EXPIRES: 20220219 |
| 1769785 | 91972 | Luxembourg | ⤷ Sign Up | 91972, EXPIRES: 20220219 |
| 1769785 | CA 2012 00012 | Denmark | ⤷ Sign Up | |
| 1769785 | C300521 | Netherlands | ⤷ Sign Up | PRODUCT NAME: FENTANYL; REG NO/DATE: EU/2/11/127/001 20111006 |
| 1769785 | CA 2012 00011 | Denmark | ⤷ Sign Up | |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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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