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Details for New Drug Application (NDA): 022504
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NDA 022504 describes AXIRON, which is a drug marketed by Eli Lilly And Co and is included in one NDA. There are seven patents protecting this drug and one Paragraph IV challenge. Additional details are available on the AXIRON profile page.
The generic ingredient in AXIRON is testosterone. There are sixty-nine drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the testosterone profile page.
The generic ingredient in AXIRON is testosterone. There are sixty-nine drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the testosterone profile page.
Summary for 022504
| Tradename: | AXIRON |
| Applicant: | Eli Lilly And Co |
| Ingredient: | testosterone |
| Patents: | 7 |
| Formulation / Manufacturing: | see details |
Medical Subject Heading (MeSH) Categories for 022504
Paragraph IV (Patent) Challenges for 022504
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| AXIRON | SOLUTION, METERED;TRANSDERMAL | testosterone | 022504 | 2013-01-29 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION, METERED;TRANSDERMAL | Strength | 30MG/1.5ML ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | ||||
| Approval Date: | Nov 23, 2010 | TE: | RLD: | Yes | |||||
| Patent: | Start Trial | Patent Expiration: | Feb 26, 2027 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | A METHOD OF INCREASING THE TESTOSTERONE BLOOD LEVEL OF A PERSON IN NEED THEREOF | ||||||||
| Patent: | Start Trial | Patent Expiration: | Sep 27, 2027 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | A METHOD OF INCREASING THE TESTOSTERONE BLOOD LEVEL OF AN ADULT MALE SUBJECT IN NEED THEREOF | ||||||||
| Patent: | Start Trial | Patent Expiration: | Jul 13, 2023 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | A METHOD OF TRANSDERMALLY DELIVERING TESTOSTERONE | ||||||||
Expired US Patents for NDA 022504
| 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 | Start Trial | Start Trial |
| Eli Lilly And Co | AXIRON | testosterone | SOLUTION, METERED;TRANSDERMAL | 022504-001 | Nov 23, 2010 | Start Trial | Start Trial |
| Eli Lilly And Co | AXIRON | testosterone | SOLUTION, METERED;TRANSDERMAL | 022504-001 | Nov 23, 2010 | Start Trial | Start Trial |
| Eli Lilly And Co | AXIRON | testosterone | SOLUTION, METERED;TRANSDERMAL | 022504-001 | Nov 23, 2010 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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