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Last Updated: August 12, 2020

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XANAX Drug Profile

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When do Xanax patents expire, and what generic alternatives are available?

Xanax is a drug marketed by Upjohn and is included in two NDAs.

The generic ingredient in XANAX is alprazolam. There are fifteen drug master file entries for this compound. Thirty-nine suppliers are listed for this compound. Additional details are available on the alprazolam profile page.

US ANDA Litigation and Generic Entry Outlook for Xanax

A generic version of XANAX was approved as alprazolam by HIKMA on October 31st, 1993.

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Paragraph IV (Patent) Challenges for XANAX
Tradename Dosage Ingredient NDA Submissiondate
XANAX TABLET;ORAL alprazolam 018276

US Patents and Regulatory Information for XANAX

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Upjohn XANAX alprazolam TABLET;ORAL 018276-001 Approved Prior to Jan 1, 1982 AB RX Yes No   Start Trial   Start Trial   Start Trial
Upjohn XANAX XR alprazolam TABLET, EXTENDED RELEASE;ORAL 021434-003 Jan 17, 2003 AB RX Yes No   Start Trial   Start Trial   Start Trial
Upjohn XANAX alprazolam TABLET;ORAL 018276-004 Nov 27, 1985 AB RX Yes No   Start Trial   Start Trial   Start Trial
Upjohn XANAX XR alprazolam TABLET, EXTENDED RELEASE;ORAL 021434-004 Jan 17, 2003 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Upjohn XANAX alprazolam TABLET;ORAL 018276-002 Approved Prior to Jan 1, 1982 AB RX Yes No   Start Trial   Start Trial   Start Trial
Upjohn XANAX alprazolam TABLET;ORAL 018276-003 Approved Prior to Jan 1, 1982 AB RX Yes Yes   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 XANAX

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Upjohn XANAX alprazolam TABLET;ORAL 018276-002 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Upjohn XANAX alprazolam TABLET;ORAL 018276-001 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Upjohn XANAX alprazolam TABLET;ORAL 018276-003 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Upjohn XANAX alprazolam TABLET;ORAL 018276-004 Nov 27, 1985   Start Trial   Start Trial
Upjohn XANAX alprazolam TABLET;ORAL 018276-001 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Upjohn XANAX alprazolam TABLET;ORAL 018276-003 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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