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Last Updated: November 29, 2020

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AMRIX Drug Profile

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

Amrix is a drug marketed by Teva Pharms Intl and is included in one NDA. There are eight patents protecting this drug and one Paragraph IV challenge.

This drug has one patent family member in one country.

The generic ingredient in AMRIX is cyclobenzaprine hydrochloride. There are sixteen drug master file entries for this compound. Fifty-three suppliers are listed for this compound. Additional details are available on the cyclobenzaprine hydrochloride profile page.

Paragraph IV (Patent) Challenges for AMRIX
Tradename Dosage Ingredient NDA Submissiondate
AMRIX CAPSULE, EXTENDED RELEASE;ORAL cyclobenzaprine hydrochloride 021777 2008-08-11

US Patents and Regulatory Information for AMRIX

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Teva Pharms Intl AMRIX cyclobenzaprine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021777-001 Feb 1, 2007 AB RX Yes No   Start Trial   Start Trial   Start Trial
Teva Pharms Intl AMRIX cyclobenzaprine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021777-001 Feb 1, 2007 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Teva Pharms Intl AMRIX cyclobenzaprine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021777-001 Feb 1, 2007 AB RX Yes No   Start Trial   Start Trial   Start Trial
Teva Pharms Intl AMRIX cyclobenzaprine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021777-002 Feb 1, 2007 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Teva Pharms Intl AMRIX cyclobenzaprine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021777-001 Feb 1, 2007 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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