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Last Updated: February 28, 2020

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TUXARIN ER Drug Profile


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When do Tuxarin Er patents expire, and when can generic versions of Tuxarin Er launch?

Tuxarin Er is a drug marketed by Mainpointe and is included in one NDA. There are four patents protecting this drug.

This drug has fifty-eight patent family members in eleven countries.

The generic ingredient in TUXARIN ER is chlorpheniramine maleate; codeine phosphate. There are twenty-nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the chlorpheniramine maleate; codeine phosphate profile page.

US ANDA Litigation and Generic Entry Outlook for Tuxarin Er

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be January 3, 2032. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for TUXARIN ER
International Patents:58
US Patents:4
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Bulk Api Vendors: 1
Formulation / Manufacturing:see details
DailyMed Link:TUXARIN ER at DailyMed
Drug patent expirations by year for TUXARIN ER
Generic Entry Opportunity Date for TUXARIN ER
Generic Entry Date for TUXARIN ER*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET, EXTENDED RELEASE;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Synonyms for TUXARIN ER
60540-98-9
Chlorpheniramine maleate / codeine phosphate
Chlorpheniramine maleate and codeine phosphate
Chlorpheniramine maleate mixture with codeine phosphate
Codeine Phosphate / Chlorpheniramine Maleate
Codeine Phosphate and Chlorpheniramine Maleate
Zodryl AC

US Patents and Regulatory Information for TUXARIN ER

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mainpointe TUXARIN ER chlorpheniramine maleate; codeine phosphate TABLET, EXTENDED RELEASE;ORAL 206323-001 Jun 22, 2015 RX No No   Start Trial   Start Trial Y   Start Trial
Mainpointe TUXARIN ER chlorpheniramine maleate; codeine phosphate TABLET, EXTENDED RELEASE;ORAL 206323-001 Jun 22, 2015 RX No No   Start Trial   Start Trial Y   Start Trial
Mainpointe TUXARIN ER chlorpheniramine maleate; codeine phosphate TABLET, EXTENDED RELEASE;ORAL 206323-001 Jun 22, 2015 RX No No   Start Trial   Start Trial   Start Trial
Mainpointe TUXARIN ER chlorpheniramine maleate; codeine phosphate TABLET, EXTENDED RELEASE;ORAL 206323-001 Jun 22, 2015 RX No 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

Expired US Patents for TUXARIN ER

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Mainpointe TUXARIN ER chlorpheniramine maleate; codeine phosphate TABLET, EXTENDED RELEASE;ORAL 206323-001 Jun 22, 2015   Start Trial   Start Trial
Mainpointe TUXARIN ER chlorpheniramine maleate; codeine phosphate TABLET, EXTENDED RELEASE;ORAL 206323-001 Jun 22, 2015   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:

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Mallinckrodt

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 verifification 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.