ANDRODERM Drug Patent Profile
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Which patents cover Androderm, and when can generic versions of Androderm launch?
Androderm is a drug marketed by Abbvie and is included in one NDA.
The generic ingredient in ANDRODERM 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 Androderm
A generic version of ANDRODERM was approved as testosterone by ACTAVIS LABS UT INC on January 27th, 2006.
Summary for ANDRODERM
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 73 |
Clinical Trials: | 4 |
Patent Applications: | 4,336 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for ANDRODERM |
Drug Sales Revenues: | Drug sales revenues for ANDRODERM |
What excipients (inactive ingredients) are in ANDRODERM? | ANDRODERM excipients list |
DailyMed Link: | ANDRODERM at DailyMed |
Recent Clinical Trials for ANDRODERM
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Allergan | Phase 4 |
M.D. Anderson Cancer Center | Phase 3 |
Trimel Biopharma SRL | Phase 2 |
Pharmacology for ANDRODERM
Drug Class | Androgen |
Mechanism of Action | Androgen Receptor Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for ANDRODERM
US Patents and Regulatory Information for ANDRODERM
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Abbvie | ANDRODERM | testosterone | FILM, EXTENDED RELEASE;TRANSDERMAL | 020489-003 | Oct 20, 2011 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Abbvie | ANDRODERM | testosterone | FILM, EXTENDED RELEASE;TRANSDERMAL | 020489-002 | May 2, 1997 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Abbvie | ANDRODERM | testosterone | FILM, EXTENDED RELEASE;TRANSDERMAL | 020489-001 | Sep 29, 1995 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ 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 ANDRODERM
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Abbvie | ANDRODERM | testosterone | FILM, EXTENDED RELEASE;TRANSDERMAL | 020489-002 | May 2, 1997 | ⤷ Try a Trial | ⤷ Try a Trial |
Abbvie | ANDRODERM | testosterone | FILM, EXTENDED RELEASE;TRANSDERMAL | 020489-001 | Sep 29, 1995 | ⤷ Try a Trial | ⤷ Try a Trial |
Abbvie | ANDRODERM | testosterone | FILM, EXTENDED RELEASE;TRANSDERMAL | 020489-001 | Sep 29, 1995 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for ANDRODERM
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 ANDRODERM
See the table below for patents covering ANDRODERM around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Ireland | 914300 | ⤷ Try a Trial | |
Japan | H06503252 | ⤷ Try a Trial | |
South Korea | 0143916 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |