DUTASTERIDE - Generic Drug Details
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What are the generic drug sources for dutasteride and what is the scope of freedom to operate?
Dutasteride
is the generic ingredient in four branded drugs marketed by Woodward, Acella, Actavis Labs Fl Inc, Adaptis, Amneal Pharms, Apotex, Ascent Pharms Inc, Aurobindo Pharma Ltd, Barr, Bionpharma, Heritage Pharms Inc, Hikma, Humanwell Puracap, Mylan, Nostrum Labs Inc, Rising, Strides Pharma, Vintage, Zydus Lifesciences, Anchen Pharms, and Zydus Pharms, and is included in twenty-four NDAs. Additional information is available in the individual branded drug profile pages.There are eighteen drug master file entries for dutasteride. Seventeen suppliers are listed for this compound.
Summary for DUTASTERIDE
US Patents: | 0 |
Tradenames: | 4 |
Applicants: | 21 |
NDAs: | 24 |
Drug Master File Entries: | 18 |
Finished Product Suppliers / Packagers: | 17 |
Raw Ingredient (Bulk) Api Vendors: | 92 |
Clinical Trials: | 111 |
Patent Applications: | 6,558 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends for DUTASTERIDE |
What excipients (inactive ingredients) are in DUTASTERIDE? | DUTASTERIDE excipients list |
DailyMed Link: | DUTASTERIDE at DailyMed |
Recent Clinical Trials for DUTASTERIDE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Masonic Cancer Center, University of Minnesota | Phase 2 |
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal | Phase 2 |
Radboud University Medical Center | Phase 2 |
Pharmacology for DUTASTERIDE
Drug Class | 5-alpha Reductase Inhibitor |
Mechanism of Action | 5-alpha Reductase Inhibitors |
Medical Subject Heading (MeSH) Categories for DUTASTERIDE
Paragraph IV (Patent) Challenges for DUTASTERIDE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
AVODART | Capsules | dutasteride | 0.5 mg | 021319 | 1 | 2007-10-29 |
US Patents and Regulatory Information for DUTASTERIDE
Expired US Patents for DUTASTERIDE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Woodward | AVODART | dutasteride | CAPSULE;ORAL | 021319-001 | Nov 20, 2001 | ⤷ Try a Trial | ⤷ Try a Trial |
Woodward | AVODART | dutasteride | CAPSULE;ORAL | 021319-001 | Nov 20, 2001 | ⤷ Try a Trial | ⤷ Try a Trial |
Woodward | AVODART | dutasteride | CAPSULE;ORAL | 021319-001 | Nov 20, 2001 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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