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 |
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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 verification 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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