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, Norvium Bioscience, 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 |
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 |
---|---|
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | N/A |
Beth Israel Deaconess Medical Center | N/A |
Gundersen Lutheran Medical Foundation | Phase 4 |
Pharmacology for alfuzosin hydrochloride
Drug Class | alpha-Adrenergic Blocker |
Mechanism of Action | Adrenergic alpha-Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes for alfuzosin hydrochloride
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Invagen Pharms | ALFUZOSIN HYDROCHLORIDE | alfuzosin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 090284-001 | Jan 17, 2012 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Wockhardt | ALFUZOSIN HYDROCHLORIDE | alfuzosin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 090221-001 | Aug 10, 2012 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Sun Pharm | ALFUZOSIN HYDROCHLORIDE | alfuzosin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 079057-001 | Jul 18, 2011 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Aurobindo Pharma Ltd | ALFUZOSIN HYDROCHLORIDE | alfuzosin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 079060-001 | Aug 30, 2012 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Concordia | UROXATRAL | alfuzosin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021287-001 | Jun 12, 2003 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
>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 | ⤷ Sign Up | ⤷ Sign Up |
Concordia | UROXATRAL | alfuzosin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021287-001 | Jun 12, 2003 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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