Testosterone - Generic Drug Details
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What are the generic sources for testosterone and what is the scope of freedom to operate?
Testosterone
is the generic ingredient in twenty-two branded drugs marketed by Abbvie, Alza, Acerus, Besins Hlthcare, Endo Operations, Actavis Labs Ut Inc, Alembic, Amneal, Encube, Lupin, Padagis Israel, Perrigo Israel, Twi Pharms, Xiromed, Upsher Smith Labs, Ani Pharms, Strides Pharma, Dr Reddys, Watson Labs, Eli Lilly And Co, Apotex, Cipla, Lupin Ltd, Auxilium Pharms Llc, Pfizer, Am Regent, Eugia Pharma, Hikma, Hikma Farmaceutica, Padagis Us, Rising, Sandoz, Sun Pharm Inds Ltd, Watson Pharms Inc, Wilshire Pharms Inc, Azurity, Endo Pharms, Nexus, Antares Pharma Inc, Bel Mar, Elkins Sinn, Lilly, Tolmar, Marius Pharms Llc, and Verity, and is included in seventy-six NDAs. There are seventy-six patents protecting this compound and six Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Testosterone has one hundred and twenty patent family members in thirty-nine countries.
There are sixty-nine drug master file entries for testosterone. Nineteen suppliers are listed for this compound. There are two tentative approvals for this compound.
Summary for testosterone
| International Patents: | 120 |
| US Patents: | 76 |
| Tradenames: | 22 |
| Applicants: | 45 |
| NDAs: | 76 |
| Drug Master File Entries: | 69 |
| Finished Product Suppliers / Packagers: | 19 |
| Raw Ingredient (Bulk) Api Vendors: | 73 |
| Clinical Trials: | 1,045 |
| Patent Applications: | 7,232 |
| Drug Prices: | Drug price trends for testosterone |
| Drug Sales Revenues: | Drug sales revenues for testosterone |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for testosterone |
| What excipients (inactive ingredients) are in testosterone? | testosterone excipients list |
| DailyMed Link: | testosterone at DailyMed |
Recent Clinical Trials for testosterone
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Morten Hostrup, PhD | N/A |
| VA Office of Research and Development | Early Phase 1 |
| Jonsson Comprehensive Cancer Center | Phase 2 |
Generic filers with tentative approvals for TESTOSTERONE
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for testosterone
| Drug Class | Androgen |
| Mechanism of Action | Androgen Receptor Agonists |
Medical Subject Heading (MeSH) Categories for testosterone
Anatomical Therapeutic Chemical (ATC) Classes for testosterone
Paragraph IV (Patent) Challenges for TESTOSTERONE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| AXIRON | Topical Solution | testosterone | 30 mg/1.5 mL | 022504 | 1 | 2013-01-29 |
| FORTESTA | Gel | testosterone | 10 mg/actuation | 021463 | 1 | 2012-08-14 |
| TESTIM | Gel | testosterone | 1% | 021454 | 1 | 2008-08-21 |
US Patents and Regulatory Information for testosterone
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Watson Labs | TESTOSTERONE | testosterone | INJECTABLE;INJECTION | 086419-001 | Aug 23, 1983 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Antares Pharma Inc | XYOSTED (AUTOINJECTOR) | testosterone enanthate | SOLUTION;SUBCUTANEOUS | 209863-002 | Sep 28, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Upsher Smith Labs | VOGELXO | testosterone | GEL, METERED;TRANSDERMAL | 204399-003 | Jun 4, 2014 | BX | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ 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 testosterone
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Abbvie | ANDRODERM | testosterone | FILM, EXTENDED RELEASE;TRANSDERMAL | 020489-002 | May 2, 1997 | ⤷ Sign Up | ⤷ Sign Up |
| Besins Hlthcare | ANDROGEL | testosterone | GEL, METERED;TRANSDERMAL | 021015-003 | Sep 26, 2003 | ⤷ Sign Up | ⤷ Sign Up |
| Eli Lilly And Co | AXIRON | testosterone | SOLUTION, METERED;TRANSDERMAL | 022504-001 | Nov 23, 2010 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for testosterone
| 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 testosterone
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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.
ISSN: 2162-2639
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