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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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