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Last Updated: June 6, 2020

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CARDURA Drug Profile


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Which patents cover Cardura, and when can generic versions of Cardura launch?

Cardura is a drug marketed by Pfizer and is included in two NDAs.

The generic ingredient in CARDURA is doxazosin mesylate. There are fourteen drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the doxazosin mesylate profile page.

US ANDA Litigation and Generic Entry Outlook for Cardura

A generic version of CARDURA was approved as doxazosin mesylate by APOTEX on October 18th, 2000.

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Paragraph IV (Patent) Challenges for CARDURA
Tradename Dosage Ingredient NDA Submissiondate
CARDURA TABLET;ORAL doxazosin mesylate 019668

US Patents and Regulatory Information for CARDURA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pfizer CARDURA doxazosin mesylate TABLET;ORAL 019668-001 Nov 2, 1990 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Pfizer CARDURA doxazosin mesylate TABLET;ORAL 019668-004 Nov 2, 1990 AB RX Yes No   Start Trial   Start Trial   Start Trial
Pfizer CARDURA doxazosin mesylate TABLET;ORAL 019668-002 Nov 2, 1990 AB RX Yes No   Start Trial   Start Trial   Start Trial
Pfizer CARDURA doxazosin mesylate TABLET;ORAL 019668-003 Nov 2, 1990 AB RX Yes No   Start Trial   Start Trial   Start Trial
Pfizer CARDURA XL doxazosin mesylate TABLET, EXTENDED RELEASE;ORAL 021269-002 Feb 22, 2005 RX Yes Yes   Start Trial   Start Trial   Start Trial
Pfizer CARDURA XL doxazosin mesylate TABLET, EXTENDED RELEASE;ORAL 021269-001 Feb 22, 2005 RX Yes 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 CARDURA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer CARDURA doxazosin mesylate TABLET;ORAL 019668-001 Nov 2, 1990   Start Trial   Start Trial
Pfizer CARDURA doxazosin mesylate TABLET;ORAL 019668-003 Nov 2, 1990   Start Trial   Start Trial
Pfizer CARDURA doxazosin mesylate TABLET;ORAL 019668-002 Nov 2, 1990   Start Trial   Start Trial
Pfizer CARDURA doxazosin mesylate TABLET;ORAL 019668-004 Nov 2, 1990   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

McKesson
Johnson and Johnson
Baxter
Merck
Dow
McKinsey

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