ANDROGEL Drug Patent Profile
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Which patents cover Androgel, and when can generic versions of Androgel launch?
Androgel is a drug marketed by Besins Hlthcare and is included in two NDAs. There are eight patents protecting this drug.
This drug has forty-five patent family members in twenty-nine countries.
The generic ingredient in ANDROGEL is testosterone. There are sixty-nine drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the testosterone profile page.
DrugPatentWatch® 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: | 45 |
US Patents: | 8 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 67 |
Clinical Trials: | 54 |
Patent Applications: | 4,334 |
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 |
---|---|
University Medical Center Groningen | N/A |
Harvard University | Phase 4 |
Cedars-Sinai Medical Center | Phase 4 |
Pharmacology for ANDROGEL
Drug Class | Androgen |
Mechanism of Action | Androgen Receptor Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for ANDROGEL
US Patents and Regulatory Information for ANDROGEL
ANDROGEL is protected by eight US patents.
Patents protecting ANDROGEL
Testosterone gel and method of use
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Testosterone gel and method of use
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE
Testosterone gel and method of use
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE
Testosterone gel and method of use
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Testosterone gel and method of use
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Testosterone gel and method of use
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE
Testosterone gel and method of use
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Testosterone gel and method of use
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Besins Hlthcare | ANDROGEL | testosterone | GEL, METERED;TRANSDERMAL | 022309-001 | Apr 29, 2011 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Besins Hlthcare | ANDROGEL | testosterone | GEL;TRANSDERMAL | 022309-003 | Sep 7, 2012 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Besins Hlthcare | ANDROGEL | testosterone | GEL;TRANSDERMAL | 022309-003 | Sep 7, 2012 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Besins Hlthcare | ANDROGEL | testosterone | GEL, METERED;TRANSDERMAL | 022309-001 | Apr 29, 2011 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a 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 |
---|---|---|---|---|---|---|---|
Besins Hlthcare | ANDROGEL | testosterone | GEL;TRANSDERMAL | 021015-002 | Feb 28, 2000 | ⤷ Try a Trial | ⤷ Try a Trial |
Besins Hlthcare | ANDROGEL | testosterone | GEL, METERED;TRANSDERMAL | 022309-001 | Apr 29, 2011 | ⤷ Try a Trial | ⤷ Try a Trial |
Besins Hlthcare | ANDROGEL | testosterone | GEL, METERED;TRANSDERMAL | 021015-003 | Sep 26, 2003 | ⤷ Try a Trial | ⤷ Try a Trial |
Besins Hlthcare | ANDROGEL | testosterone | GEL;TRANSDERMAL | 021015-002 | Feb 28, 2000 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for ANDROGEL
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Warner Chilcott UK Ltd. | Intrinsa | testosterone | EMEA/H/C/000634 Intrinsa is indicated for the treatment of hypoactive sexual desire disorder (HSDD) in bilaterally oophorectomised and hysterectomised (surgically induced menopause) women receiving concomitant estrogen therapy. |
Withdrawn | no | no | no | 2006-07-28 | |
Warner Chilcott Deutschland GmbH | Livensa | testosterone | EMEA/H/C/000630 Livensa is indicated for the treatment of hypoactive sexual desire disorder (HSDD) in bilaterally oophorectomised and hysterectomised (surgically induced menopause) women receiving concomitant estrogen therapy. |
Withdrawn | no | no | no | 2006-07-28 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for ANDROGEL
See the table below for patents covering ANDROGEL around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | 2006505587 | ⤷ Try a Trial | |
Denmark | 1322336 | ⤷ Try a Trial | |
China | 1473047 | ⤷ Try a Trial | |
World Intellectual Property Organization (WIPO) | 2004037173 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |