Testosterone undecanoate - Generic Drug Details
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What are the generic drug sources for testosterone undecanoate and what is the scope of freedom to operate?
Testosterone undecanoate
is the generic ingredient in three branded drugs marketed by Clarus, Antares Pharma Inc, and Endo Pharms Inc, and is included in three NDAs. There are sixteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Testosterone undecanoate has one hundred and nine patent family members in thirty-eight countries.
There are seven drug master file entries for testosterone undecanoate. Three suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for testosterone undecanoate
International Patents: | 109 |
US Patents: | 16 |
Tradenames: | 3 |
Applicants: | 3 |
NDAs: | 3 |
Drug Master File Entries: | 7 |
Finished Product Suppliers / Packagers: | 3 |
Raw Ingredient (Bulk) Api Vendors: | 49 |
Clinical Trials: | 56 |
Patent Applications: | 2,523 |
Formulation / Manufacturing: | see details |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for testosterone undecanoate |
What excipients (inactive ingredients) are in testosterone undecanoate? | testosterone undecanoate excipients list |
DailyMed Link: | testosterone undecanoate at DailyMed |
Recent Clinical Trials for testosterone undecanoate
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Phase 2 |
Clarus Therapeutics | Phase 2 |
Clarus Therapeutics | Phase 4 |
Generic filers with tentative approvals for TESTOSTERONE UNDECANOATE
Applicant | Application No. | Strength | Dosage Form |
See Plans and Pricing | See Plans and Pricing | 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 undecanoate
Drug Class | Androgen |
Mechanism of Action | Androgen Receptor Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for testosterone undecanoate
Paragraph IV (Patent) Challenges for TESTOSTERONE UNDECANOATE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
AVEED | Injection | testosterone undecanoate | 250 mg/mL | 022219 | 1 | 2014-06-11 |
US Patents and Regulatory Information for testosterone undecanoate
International Patents for testosterone undecanoate
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Mexico | 2011007351 | COMPOSICIONES ESTEROIDALES. (STEROIDAL COMPOSITIONS.) | See Plans and Pricing |
Japan | 2016514706 | 経口送達用リポバランス長鎖テストステロンエステル | See Plans and Pricing |
Costa Rica | 7999 | METODOS Y COMPOSICIONES FARMACEUTICAS PARA LA OBTENCION CONFIABLE DE NIVELES ACEPTABLES DE TESTOSTERONA EN SUERO | See Plans and Pricing |
South Korea | 20080096717 | METHODS AND PHARMACEUTICAL COMPOSITIONS FOR RELIABLE ACHIEVEMENT OF ACCEPTABLE SERUM TESTOSTERONE LEVELS | See Plans and Pricing |
Russian Federation | 2015128028 | ДЛИННОЦЕПОЧЕЧНЫЕ ЛИПОСБАЛАНСИРОВАННЫЕ СЛОЖНЫЕ ЭФИРЫ ТЕСТОСТЕРОНА ДЛЯ ПЕРОРАЛЬНОЙ ДОСТАВКИ | See Plans and Pricing |
Japan | 2015120700 | ステロイド組成物 (STEROIDAL COMPOSITIONS) | See Plans and Pricing |
Argentina | 043603 | COMPOSICIONES INYECTABLES PARA USO INTRAMUSCULAR CONTENIENDO ESTERES DE TESTOSTERONA Y UN VEHICULO QUE COMPRENDE ACEITE DE RICINO Y UN COSOLVENTE | See Plans and Pricing |
>Country | >Patent Number | >Title | >Estimated Expiration |
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