TESTIM Drug Patent Profile
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When do Testim patents expire, and what generic alternatives are available?
Testim is a drug marketed by Auxilium Pharms Llc and is included in one NDA.
The generic ingredient in TESTIM 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 Testim
A generic version of TESTIM was approved as testosterone by ACTAVIS LABS UT INC on January 27th, 2006.
Summary for TESTIM
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 73 |
Clinical Trials: | 16 |
Patent Applications: | 4,287 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for TESTIM |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for TESTIM |
What excipients (inactive ingredients) are in TESTIM? | TESTIM excipients list |
DailyMed Link: | TESTIM at DailyMed |
![TESTIM drug patent expirations Drug patent expirations by year for TESTIM](/p/graph/s/t/TESTIM-patent-expirations.png)
![Drug Prices for TESTIM](/p/graph/drug-price/TESTIM.png)
![Drug Sales Revenue Trends for TESTIM](/p/graph/drug-sales-revenues/TESTIM.png)
Recent Clinical Trials for TESTIM
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Endo Pharmaceuticals | Phase 4 |
Instituto de Investigacion Sanitaria La Fe | Phase 3 |
Marianne Andersen | Phase 4 |
Pharmacology for TESTIM
Drug Class | Androgen |
Mechanism of Action | Androgen Receptor Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for TESTIM
Paragraph IV (Patent) Challenges for TESTIM
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
TESTIM | Gel | testosterone | 1% | 021454 | 1 | 2008-08-21 |
US Patents and Regulatory Information for TESTIM
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Auxilium Pharms Llc | TESTIM | testosterone | GEL;TRANSDERMAL | 021454-001 | Oct 31, 2002 | AB2 | RX | Yes | Yes | ⤷ 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 TESTIM
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Auxilium Pharms Llc | TESTIM | testosterone | GEL;TRANSDERMAL | 021454-001 | Oct 31, 2002 | ⤷ Try a Trial | ⤷ Try a Trial |
Auxilium Pharms Llc | TESTIM | testosterone | GEL;TRANSDERMAL | 021454-001 | Oct 31, 2002 | ⤷ Try a Trial | ⤷ Try a Trial |
Auxilium Pharms Llc | TESTIM | testosterone | GEL;TRANSDERMAL | 021454-001 | Oct 31, 2002 | ⤷ Try a Trial | ⤷ Try a Trial |
Auxilium Pharms Llc | TESTIM | testosterone | GEL;TRANSDERMAL | 021454-001 | Oct 31, 2002 | ⤷ Try a Trial | ⤷ Try a Trial |
Auxilium Pharms Llc | TESTIM | testosterone | GEL;TRANSDERMAL | 021454-001 | Oct 31, 2002 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for TESTIM
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 TESTIM
See the table below for patents covering TESTIM around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Egypt | 24882 | Testosterone gel/macrocyclic enhancer | ⤷ Try a Trial |
Spain | 2292964 | ⤷ Try a Trial | |
World Intellectual Property Organization (WIPO) | 8703473 | ⤷ Try a Trial | |
Taiwan | I362932 | ⤷ Try a Trial | |
Hong Kong | 1082682 | PHARMACEUTICAL COMPOSITION | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for TESTIM
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
8703473 | 91289 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: TESTIM; REGISRATION NO 1768/92 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |