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ANDROGEL Drug Profile
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» See Plans and PricingWhich patents cover Androgel, and when can generic versions of Androgel launch?
Androgel is a drug marketed by Abbvie and is included in two NDAs. There are eleven patents protecting this drug and three Paragraph IV challenges.
This drug has one hundred and sixty-one patent family members in thirty-seven countries.
The generic ingredient in ANDROGEL 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.
US ANDA Litigation and Generic Entry Outlook for Androgel
A generic version of ANDROGEL was approved as testosterone by ACTAVIS LABS UT INC on January 27th, 2006.
Summary for ANDROGEL
| International Patents: | 161 |
| US Patents: | 11 |
| Applicants: | 1 |
| NDAs: | 2 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 61 |
| Clinical Trials: | 40 |
| Patent Applications: | 4,263 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for ANDROGEL |
| Drug Sales Revenues: | Drug sales revenues for ANDROGEL |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ANDROGEL |
| DailyMed Link: | ANDROGEL at DailyMed |
Pharmacology for ANDROGEL
| Drug Class | Androgen |
| Mechanism of Action | Androgen Receptor Agonists |
US Patents and Regulatory Information for ANDROGEL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Abbvie | ANDROGEL | testosterone | GEL;TRANSDERMAL | 021015-002 | Feb 28, 2000 | AB1 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
| Abbvie | ANDROGEL | testosterone | GEL;TRANSDERMAL | 022309-003 | Sep 7, 2012 | AB2 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
| Abbvie | ANDROGEL | testosterone | GEL;TRANSDERMAL | 022309-003 | Sep 7, 2012 | AB2 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
| Abbvie | ANDROGEL | testosterone | GEL;TRANSDERMAL | 022309-003 | Sep 7, 2012 | AB2 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for ANDROGEL
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Canada | 2624788 | Start Trial |
| South Korea | 20030048021 | Start Trial |
| European Patent Office | 2070517 | Start Trial |
| Norway | 334991 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
