TESTIM Drug Patent Profile
✉ Email this page to a colleague
When do Testim patents expire, and what generic alternatives are available?
Testim is a drug marketed by Endo Operations and is included in one NDA.
The generic ingredient in TESTIM is testosterone. There are sixty-nine drug master file entries for this compound. Nineteen 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.
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for TESTIM?
- What are the global sales for TESTIM?
- What is Average Wholesale Price for TESTIM?
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: | 4,302 |
| 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 |
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 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Endo Operations | TESTIM | testosterone | GEL;TRANSDERMAL | 021454-001 | Oct 31, 2002 | AB2 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >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 |
|---|---|---|---|---|---|---|---|
| Endo Operations | TESTIM | testosterone | GEL;TRANSDERMAL | 021454-001 | Oct 31, 2002 | ⤷ Sign Up | ⤷ Sign Up |
| Endo Operations | TESTIM | testosterone | GEL;TRANSDERMAL | 021454-001 | Oct 31, 2002 | ⤷ Sign Up | ⤷ Sign Up |
| Endo Operations | TESTIM | testosterone | GEL;TRANSDERMAL | 021454-001 | Oct 31, 2002 | ⤷ Sign Up | ⤷ Sign Up |
| >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 |
|---|---|---|---|
| China | 1662243 | Pharmaceutical composition | ⤷ Sign Up |
| Mexico | PA04010311 | COMPOSICION FARMACEUTICA. (PHARMACEUTICAL COMPOSITION.) | ⤷ Sign Up |
| Iceland | 2667 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for TESTIM
Make Better Decisions: Try a trial or see plans & pricing
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.
ISSN: 2162-2639
Privacy and Cookies
Terms & Conditions
Site Map
DrugPatentWatch Alternatives
LOE / Major Patent Expirations 2024 - 2025
NCE-1 Patent Challenge Dates 2024 - 2025
Trigger-based marketing for the life sciences
Get DrugPatentWatch Business Intelligence Reports at Amazon.com
DrugChatter - AI-based answers to questions about drugs
RxJam - Digital Marketing for Life Sciences
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2024, www.DrugPatentWatch.com.
See Primary Research Papers Citing DrugPatentWatch
Follow DrugPatentWatch:
