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Serving leading biopharmaceutical companies globally:

Chubb
Citi
Mallinckrodt
Farmers Insurance
McKesson
Covington
US Department of Justice
Baxter
Boehringer Ingelheim
Federal Trade Commission

Generated: January 20, 2018

DrugPatentWatch Database Preview

AXIRON Drug 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 eleven patents protecting this drug and one Paragraph IV challenge.

This drug has ninety-one patent family members in twenty countries.

The generic ingredient in AXIRON is testosterone. There are sixty-three drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the testosterone profile page.
Summary for AXIRON
Drug patent expirations by year for AXIRON
Pharmacology for AXIRON
Ingredient-typeAndrostanes
Drug ClassAndrogen
Mechanism of ActionAndrogen Receptor Agonists
Medical Subject Heading (MeSH) Categories for AXIRON

US Patents and Regulatory Information for AXIRON

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 ➤ Subscribe ➤ Subscribe ➤ Subscribe
Eli Lilly And Co AXIRON testosterone SOLUTION, METERED;TRANSDERMAL 022504-001 Nov 23, 2010 DISCN Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Eli Lilly And Co AXIRON testosterone SOLUTION, METERED;TRANSDERMAL 022504-001 Nov 23, 2010 DISCN Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Eli Lilly And Co AXIRON testosterone SOLUTION, METERED;TRANSDERMAL 022504-001 Nov 23, 2010 DISCN Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Eli Lilly And Co AXIRON testosterone SOLUTION, METERED;TRANSDERMAL 022504-001 Nov 23, 2010 DISCN Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Eli Lilly And Co AXIRON testosterone SOLUTION, METERED;TRANSDERMAL 022504-001 Nov 23, 2010 DISCN Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Eli Lilly And Co AXIRON testosterone SOLUTION, METERED;TRANSDERMAL 022504-001 Nov 23, 2010 DISCN Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Eli Lilly And Co AXIRON testosterone SOLUTION, METERED;TRANSDERMAL 022504-001 Nov 23, 2010 DISCN Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Eli Lilly And Co AXIRON testosterone SOLUTION, METERED;TRANSDERMAL 022504-001 Nov 23, 2010 DISCN Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Eli Lilly And Co AXIRON testosterone SOLUTION, METERED;TRANSDERMAL 022504-001 Nov 23, 2010 DISCN Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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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 ➤ Subscribe ➤ Subscribe
Eli Lilly And Co AXIRON testosterone SOLUTION, METERED;TRANSDERMAL 022504-001 Nov 23, 2010 ➤ Subscribe ➤ Subscribe
Eli Lilly And Co AXIRON testosterone SOLUTION, METERED;TRANSDERMAL 022504-001 Nov 23, 2010 ➤ Subscribe ➤ Subscribe
Eli Lilly And Co AXIRON testosterone SOLUTION, METERED;TRANSDERMAL 022504-001 Nov 23, 2010 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for AXIRON
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Topical Solution 30 mg/1.5 mL ➤ Subscribe 1/29/2013

Premature patent expiration for: AXIRON

Expiration due to failure to pay maintenance fee

Patent Number Tradename Expiration Date
➤ Subscribe AXIRON ➤ Subscribe

Non-Orange Book US Patents for AXIRON

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,998,138 Topical delivery of anti-alopecia agents ➤ Subscribe
6,916,486 Transdermal delivery of analgesics ➤ Subscribe
7,438,203 Dermal penetration enhancers and drug delivery systems involving same ➤ Subscribe
8,357,393 Transdermal delivery rate control using amorphous pharmaceutical compositions ➤ Subscribe
8,177,449 Spreading implement ➤ Subscribe
6,916,487 Transdermal delivery of antiemetics ➤ Subscribe
7,094,422 Topical delivery of antifungal agents ➤ Subscribe
6,964,777 Transdermal delivery of antianxiety agents ➤ Subscribe
6,929,801 Transdermal delivery of antiparkinson agents ➤ Subscribe
7,387,789 Transdermal delivery of non-steroidal anti-inflammatory drugs ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for AXIRON

Supplementary Protection Certificates for AXIRON

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
971 Luxembourg ➤ Subscribe 91971, EXPIRES: 20220219
973 Luxembourg ➤ Subscribe 91973, EXPIRES: 20220219
2012 00012 Denmark ➤ Subscribe
2012 00010 Denmark ➤ Subscribe
2012 00011 Denmark ➤ Subscribe
00521 Netherlands ➤ Subscribe PRODUCT NAME: FENTANYL; REG NO/DATE: EU/2/11/127/001 20111006
00522 Netherlands ➤ Subscribe PRODUCT NAME: FENTANYL EN DOSERINGSAPPLICATOR; REG. NO/DATE: EU/2/11/127/001 20111006
972 Luxembourg ➤ Subscribe 91972, EXPIRES: 20220219
00523 Netherlands ➤ Subscribe PRODUCT NAME: FENTANYL; REGISTRATION NO/DATE: EU/2/11/127/001 20111006
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Chinese Patent Office
Accenture
Medtronic
Deloitte
Federal Trade Commission
Julphar
Johnson and Johnson
Colorcon

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 verifification 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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