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AXIRON Drug Profile

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Which patents cover Axiron, and what substitute generic drugs are available?

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 eighty-three patent family members in twenty countries.

The generic ingredient in AXIRON is testosterone. There are sixty-one drug master file entries for this compound. Eighteen suppliers are listed for this compound. There are two tentative approvals for this compound. Additional details are available on the testosterone profile page.

Summary for Tradename: AXIRON

Patents:11
Applicants:1
NDAs:1
Suppliers / Packagers: see list2
Bulk Api Vendors: see list52
Clinical Trials: see list7
Patent Applications: see list9,832
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:AXIRON at DailyMed

Pharmacology for Tradename: AXIRON

Ingredient-typeAndrostanes
Drug ClassAndrogen
Mechanism of ActionAndrogen Receptor Agonists
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Eli Lilly And Co
AXIRON
testosterone
SOLUTION, METERED;TRANSDERMAL022504-001Nov 23, 2010RXYesYes9,289,586► Subscribe ► Subscribe
Eli Lilly And Co
AXIRON
testosterone
SOLUTION, METERED;TRANSDERMAL022504-001Nov 23, 2010RXYesYes8,419,307► Subscribe ► Subscribe
Eli Lilly And Co
AXIRON
testosterone
SOLUTION, METERED;TRANSDERMAL022504-001Nov 23, 2010RXYesYes6,818,226► SubscribeY ► Subscribe
Eli Lilly And Co
AXIRON
testosterone
SOLUTION, METERED;TRANSDERMAL022504-001Nov 23, 2010RXYesYes8,784,878► SubscribeY ► Subscribe
Eli Lilly And Co
AXIRON
testosterone
SOLUTION, METERED;TRANSDERMAL022504-001Nov 23, 2010RXYesYes9,180,194► Subscribe ► Subscribe
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Expired Patents for Tradename: AXIRON

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Eli Lilly And Co
AXIRON
testosterone
SOLUTION, METERED;TRANSDERMAL022504-001Nov 23, 20106,923,983► Subscribe
Eli Lilly And Co
AXIRON
testosterone
SOLUTION, METERED;TRANSDERMAL022504-001Nov 23, 20108,071,075► Subscribe
Eli Lilly And Co
AXIRON
testosterone
SOLUTION, METERED;TRANSDERMAL022504-001Nov 23, 20106,818,226► Subscribe
Eli Lilly And Co
AXIRON
testosterone
SOLUTION, METERED;TRANSDERMAL022504-001Nov 23, 20106,299,900► Subscribe
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Paragraph IV activity for: AXIRON

Drugname Dosage Strength RLD Submissiondate
testosteroneTopical Solution30 mg/1.5 mLAxiron1/29/2013

Non-Orange Book Patents for Tradename: 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
8,357,393Transdermal delivery rate control using amorphous pharmaceutical compositions► Subscribe
6,916,486 Transdermal delivery of analgesics► Subscribe
7,094,422Topical delivery of antifungal agents► Subscribe
8,177,449Spreading implement► Subscribe
7,438,203Dermal penetration enhancers and drug delivery systems involving same► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: AXIRON

Country Document Number Estimated Expiration
South Korea20130114229► Subscribe
AustraliaPN814496► Subscribe
China101212975► Subscribe
Japan2012162557► Subscribe
Denmark1674068► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: AXIRON

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2012 00012Denmark► Subscribe
00522Netherlands► SubscribePRODUCT NAME: FENTANYL EN DOSERINGSAPPLICATOR; REG. NO/DATE: EU/2/11/127/001 20111006
973Luxembourg► Subscribe91973, EXPIRES: 20220219
00523Netherlands► SubscribePRODUCT NAME: FENTANYL; REGISTRATION NO/DATE: EU/2/11/127/001 20111006
972Luxembourg► Subscribe91972, EXPIRES: 20220219
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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 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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