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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 branded drugs marketed by Allergan, Alza, Acerus, Abbvie, Endo Pharms, Actavis Labs Ut Inc, Amneal, Dr Reddys, Lupin, Perrigo Israel, Twi Pharms, Xiromed, Upsher Smith Labs, Auxilium Pharms Llc, Ani Pharms Inc, Par Pharm, Perrigo Uk Finco, Watson Labs, Auxilium Pharms Inc, Eli Lilly And Co, Apotex, Cipla, Lupin Ltd, Pharmacia And Upjohn, Am Regent, Hikma Farmaceutica, Mylan Institutional, Paddock Llc, Sandoz Inc, Sun Pharm Inds Ltd, Watson Pharms Inc, West-ward Pharms Int, Wilshire Pharms Inc, Nexus Pharms, Antares Pharma Inc, Bel Mar, Elkins Sinn, Lilly, Clarus, and Endo Pharms Inc, and is included in sixty-five NDAs. There are fifty-five patents protecting this compound and six Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Testosterone has two hundred and ninety-nine patent family members in forty-four countries.
There are sixty-nine drug master file entries for testosterone. Sixteen suppliers are listed for this compound. There are three tentative approvals for this compound.
Summary for testosterone
| International Patents: | 299 |
| US Patents: | 55 |
| Tradenames: | 20 |
| Applicants: | 40 |
| NDAs: | 65 |
| Drug Master File Entries: | 69 |
| Suppliers / Packagers: | 16 |
| Bulk Api Vendors: | 61 |
| Clinical Trials: | 925 |
| Patent Applications: | 7,290 |
| Formulation / Manufacturing: | see details |
| 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 |
|---|---|
| Propella Therapeutics | Phase 1/Phase 2 |
| Baylor College of Medicine | Early Phase 1 |
| Andrew McDonald | Phase 2 |
Generic filers with tentative approvals for TESTOSTERONE
| Applicant | Application No. | Strength | Dosage Form |
| Start Trial | Start Trial | 30MG/1.5ML ACTUATION | SOLUTION, METERED;TRANSDERMAL |
| Start Trial | Start Trial | 750MG/3ML (250MG/ML) | INJECTABLE;INTRAMUSCULAR |
| Start Trial | Start Trial | UNKNOWN | UNKNOWN |
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
Paragraph IV (Patent) Challenges for TESTOSTERONE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| AXIRON | SOLUTION, METERED;TRANSDERMAL | testosterone | 022504 | 2013-01-29 |
| FORTESTA | GEL, METERED;TRANSDERMAL | testosterone | 021463 | 2012-08-14 |
| TESTIM | GEL;TRANSDERMAL | testosterone | 021454 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Upsher Smith Labs | VOGELXO | testosterone | GEL, METERED;TRANSDERMAL | 204399-003 | Jun 4, 2014 | BX | RX | No | No | Start Trial | Start Trial | Y | Start Trial | ||
| Perrigo Israel | TESTOSTERONE | testosterone | GEL, METERED;TRANSDERMAL | 203098-001 | Jan 31, 2013 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Antares Pharma Inc | XYOSTED (AUTOINJECTOR) | testosterone enanthate | SOLUTION;SUBCUTANEOUS | 209863-002 | Sep 28, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Actavis Labs Ut Inc | TESTOSTERONE | testosterone | GEL, METERED;TRANSDERMAL | 076737-003 | Mar 9, 2015 | BX | RX | No | Yes | Start Trial | Start Trial | Start Trial | |||
| Acerus | NATESTO | testosterone | GEL, METERED;NASAL | 205488-001 | May 28, 2014 | RX | No | No | Start Trial | Start Trial | Y | Start 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 testosterone
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Alza | TESTODERM | testosterone | FILM, EXTENDED RELEASE;TRANSDERMAL | 019762-002 | Oct 12, 1993 | Start Trial | Start Trial |
| Alza | TESTODERM | testosterone | FILM, EXTENDED RELEASE;TRANSDERMAL | 019762-001 | Oct 12, 1993 | Start Trial | Start Trial |
| Alza | TESTODERM TTS | testosterone | FILM, EXTENDED RELEASE;TRANSDERMAL | 020791-001 | Dec 18, 1997 | Start Trial | Start Trial |
| Abbvie | ANDROGEL | testosterone | GEL;TRANSDERMAL | 021015-001 | Feb 28, 2000 | Start Trial | Start Trial |
| Allergan | ANDRODERM | testosterone | FILM, EXTENDED RELEASE;TRANSDERMAL | 020489-002 | May 2, 1997 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for testosterone
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| European Patent Office | 2106272 | Start Trial |
| Cyprus | 1110085 | Start Trial |
| South Africa | 200803087 | Start Trial |
| New Zealand | 537360 | Start Trial |
| New Zealand | 578883 | Start Trial |
| >Country | >Patent Number | >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.
ISSN: 2162-2639
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