Alfuzosin hydrochloride - Generic Drug Details
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What are the generic drug sources for alfuzosin hydrochloride and what is the scope of freedom to operate?
Alfuzosin hydrochloride
is the generic ingredient in two branded drugs marketed by Apotex Inc, Aurobindo Pharma Ltd, Chartwell Rx, Invagen Pharms, Mylan, Sun Pharm, Torrent Pharms, Unichem, Wockhardt, and Concordia, and is included in ten NDAs. Additional information is available in the individual branded drug profile pages.There are nineteen drug master file entries for alfuzosin hydrochloride. Twelve suppliers are listed for this compound.
Summary for alfuzosin hydrochloride
| US Patents: | 0 |
| Tradenames: | 2 |
| Applicants: | 10 |
| NDAs: | 10 |
| Drug Master File Entries: | 19 |
| Finished Product Suppliers / Packagers: | 12 |
| Raw Ingredient (Bulk) Api Vendors: | 104 |
| Clinical Trials: | 45 |
| Patent Applications: | 412 |
| Formulation / Manufacturing: | see details |
| What excipients (inactive ingredients) are in alfuzosin hydrochloride? | alfuzosin hydrochloride excipients list |
| DailyMed Link: | alfuzosin hydrochloride at DailyMed |
Recent Clinical Trials for alfuzosin hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Beth Israel Deaconess Medical Center | N/A |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | N/A |
| Gundersen Lutheran Medical Foundation | Phase 4 |
Pharmacology for alfuzosin hydrochloride
| Drug Class | alpha-Adrenergic Blocker |
| Mechanism of Action | Adrenergic alpha-Antagonists |
Paragraph IV (Patent) Challenges for ALFUZOSIN HYDROCHLORIDE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| UROXATRAL | Extended-release Tablets | alfuzosin hydrochloride | 10 mg | 021287 | 9 | 2007-06-12 |
US Patents and Regulatory Information for alfuzosin hydrochloride
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Concordia | UROXATRAL | alfuzosin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021287-001 | Jun 12, 2003 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Unichem | ALFUZOSIN HYDROCHLORIDE | alfuzosin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 203192-001 | Jan 28, 2016 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Wockhardt | ALFUZOSIN HYDROCHLORIDE | alfuzosin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 090221-001 | Aug 10, 2012 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Apotex Inc | ALFUZOSIN HYDROCHLORIDE | alfuzosin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 079013-001 | Jul 18, 2011 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a 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 alfuzosin hydrochloride
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Concordia | UROXATRAL | alfuzosin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021287-001 | Jun 12, 2003 | ⤷ Try a Trial | ⤷ Try a Trial |
| Concordia | UROXATRAL | alfuzosin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021287-001 | Jun 12, 2003 | ⤷ Try a Trial | ⤷ Try a 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. 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.
ISSN: 2162-2639
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