Dutasteride - Generic Drug Details
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What are the generic drug sources for dutasteride and what is the scope of patent protection?
Dutasteride
is the generic ingredient in four branded drugs marketed by Waylis Therap, Acella, Actavis Labs Fl Inc, Adaptis, Amneal Pharms, Apotex, Ascent Pharms Inc, Aurobindo Pharma Ltd, Barr, Chartwell, Heritage Pharms Inc, Hikma, Humanwell Puracap, Onesource Specialty, Ph Health, Pharmobedient, Rising, Strides Pharma, Zydus Lifesciences, Aurobindo Pharma, and Zydus Pharms, and is included in twenty-five NDAs. Additional information is available in the individual branded drug profile pages.There are eighteen drug master file entries for dutasteride. Thirteen suppliers are listed for this compound.
Summary for dutasteride
| US Patents: | 0 |
| Tradenames: | 4 |
| Applicants: | 21 |
| NDAs: | 25 |
| Drug Master File Entries: | 18 |
| Finished Product Suppliers / Packagers: | 13 |
| Raw Ingredient (Bulk) Api Vendors: | 92 |
| Clinical Trials: | 116 |
| 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 |
|---|---|
| Chong Kun Dang Pharmaceutical | PHASE3 |
| EMS | PHASE3 |
| Bio-innova Co., Ltd | PHASE1 |
Pharmacology for dutasteride
| Drug Class | 5-alpha Reductase Inhibitor |
| Mechanism of Action | 5-alpha Reductase Inhibitors |
Medical Subject Heading (MeSH) Categories for dutasteride
Anatomical Therapeutic Chemical (ATC) Classes 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
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hikma | DUTASTERIDE | dutasteride | CAPSULE;ORAL | 202204-001 | Nov 23, 2015 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Aurobindo Pharma | DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE | dutasteride; tamsulosin hydrochloride | CAPSULE;ORAL | 213300-001 | Jul 18, 2024 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Ph Health | DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE | dutasteride; tamsulosin hydrochloride | CAPSULE;ORAL | 202509-001 | Feb 26, 2014 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ 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 dutasteride
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Waylis Therap | AVODART | dutasteride | CAPSULE;ORAL | 021319-001 | Nov 20, 2001 | 5,998,427 | ⤷ Start Trial |
| Waylis Therap | AVODART | dutasteride | CAPSULE;ORAL | 021319-001 | Nov 20, 2001 | 5,565,467 | ⤷ Start Trial |
| Waylis Therap | AVODART | dutasteride | CAPSULE;ORAL | 021319-001 | Nov 20, 2001 | 5,846,976 | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Make Better Decisions: Try a trial or see plans & pricing
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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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.
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