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ANDROGEL Drug Profile
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Which 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-three 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. Sixteen 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: | 163 |
| US Patents: | 11 |
| Applicants: | 1 |
| NDAs: | 2 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 61 |
| Clinical Trials: | 42 |
| Patent Applications: | 4,160 |
| 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 |
| What excipients (inactive ingredients) are in ANDROGEL? | ANDROGEL excipients list |
| DailyMed Link: | ANDROGEL at DailyMed |
Recent Clinical Trials for ANDROGEL
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Harvard University | Phase 4 |
| Indiana University | Phase 4 |
| National Heart, Lung, and Blood Institute (NHLBI) | Phase 4 |
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 | ||
| 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, METERED;TRANSDERMAL | 022309-001 | Apr 29, 2011 | AB | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
| >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 ANDROGEL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Abbvie | ANDROGEL | testosterone | GEL, METERED;TRANSDERMAL | 021015-003 | Sep 26, 2003 | Start Trial | Start Trial |
| Abbvie | ANDROGEL | testosterone | GEL;TRANSDERMAL | 021015-001 | Feb 28, 2000 | Start Trial | Start Trial |
| Abbvie | ANDROGEL | testosterone | GEL;TRANSDERMAL | 021015-002 | Feb 28, 2000 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ANDROGEL
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Canada | 2502607 | Start Trial |
| European Patent Office | 2450041 | Start Trial |
| Portugal | 1937276 | Start Trial |
| Germany | 60138553 | Start Trial |
| Hong Kong | 1061804 | Start Trial |
| Cyprus | 1110085 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
