TESTOSTERONE - Generic Drug Details
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What are the generic drug sources for testosterone and what is the scope of freedom to operate?
Testosterone
is the generic ingredient in twenty-three 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. Eighteen suppliers are listed for this compound. There are two tentative approvals for this compound.
Summary for TESTOSTERONE
International Patents: | 120 |
US Patents: | 76 |
Tradenames: | 23 |
Applicants: | 45 |
NDAs: | 76 |
Drug Master File Entries: | 69 |
Finished Product Suppliers / Packagers: | 18 |
Raw Ingredient (Bulk) Api Vendors: | 73 |
Clinical Trials: | 1,045 |
Patent Applications: | 7,246 |
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
Applicant | Application No. | Strength | Dosage Form |
⤷ Subscribe | ⤷ Subscribe | 30MG/1.5ML ACTUATION | SOLUTION, METERED;TRANSDERMAL |
⤷ Subscribe | ⤷ Subscribe | 750MG/3ML (250MG/ML) | INJECTABLE;INTRAMUSCULAR |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Tolmar | JATENZO | testosterone undecanoate | CAPSULE;ORAL | 206089-001 | Mar 27, 2019 | RX | Yes | No | 10,543,219 | ⤷ Subscribe | ⤷ Subscribe | ||||
Rising | TESTOSTERONE ENANTHATE | testosterone enanthate | INJECTABLE;INJECTION | 040647-001 | Oct 5, 2009 | DISCN | No | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
Antares Pharma Inc | XYOSTED (AUTOINJECTOR) | testosterone enanthate | SOLUTION;SUBCUTANEOUS | 209863-002 | Sep 28, 2018 | RX | Yes | Yes | 9,180,259 | ⤷ Subscribe | Y | ⤷ Subscribe | |||
Besins Hlthcare | ANDROGEL | testosterone | GEL, METERED;TRANSDERMAL | 022309-001 | Apr 29, 2011 | AB | RX | Yes | Yes | 8,741,881 | ⤷ Subscribe | ⤷ Subscribe | |||
Antares Pharma Inc | XYOSTED (AUTOINJECTOR) | testosterone enanthate | SOLUTION;SUBCUTANEOUS | 209863-001 | Sep 28, 2018 | RX | Yes | Yes | 11,446,441 | ⤷ Subscribe | Y | ⤷ Subscribe | |||
>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 |
---|---|---|---|---|---|---|---|
Endo Operations | TESTIM | testosterone | GEL;TRANSDERMAL | 021454-001 | Oct 31, 2002 | 7,608,609 | ⤷ Subscribe |
Besins Hlthcare | ANDROGEL | testosterone | GEL, METERED;TRANSDERMAL | 022309-001 | Apr 29, 2011 | 9,132,089*PED | ⤷ Subscribe |
Acerus | NATESTO | testosterone | GEL, METERED;NASAL | 205488-001 | May 28, 2014 | 8,784,869 | ⤷ Subscribe |
Besins Hlthcare | ANDROGEL | testosterone | GEL, METERED;TRANSDERMAL | 022309-001 | Apr 29, 2011 | 9,125,816*PED | ⤷ Subscribe |
Abbvie | ANDRODERM | testosterone | FILM, EXTENDED RELEASE;TRANSDERMAL | 020489-002 | May 2, 1997 | 4,983,395 | ⤷ Subscribe |
>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
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Russian Federation | 2006120468 | СИСТЕМА ДОСТАВКИ С КОНТРОЛИРУЕМЫМ ВЫСВОБОЖДЕНИЕМ ДЛЯ НАЗАЛЬНОГО ПРИМЕНЕНИЯ | ⤷ Subscribe |
Taiwan | I350176 | ⤷ Subscribe | |
Turkey | 201815853 | ⤷ Subscribe | |
Norway | 344564 | ⤷ Subscribe | |
European Patent Office | 2450041 | Gel améliore à base de testostérone pour utilisation dans le traitment de l'hypogonadisme (Improved testosterone gel for use in the treatment of hypogonadism) | ⤷ Subscribe |
>Country | >Patent Number | >Title | >Estimated Expiration |
TESTOSTERONE Market Analysis and Financial Projection Experimental
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