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Last Updated: July 11, 2020

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Details for New Drug Application (NDA): 206323


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NDA 206323 describes TUXARIN ER, which is a drug marketed by Mainpointe and is included in one NDA. There are two patents protecting this drug. Additional details are available on the TUXARIN ER profile page.

The generic ingredient in TUXARIN ER is chlorpheniramine maleate; codeine phosphate. There are twenty-nine drug master file entries for this compound. Additional details are available on the chlorpheniramine maleate; codeine phosphate profile page.
Summary for 206323
Tradename:TUXARIN ER
Applicant:Mainpointe
Ingredient:chlorpheniramine maleate; codeine phosphate
Patents:2
Generic Entry Opportunity Date for 206323
Generic Entry Date for 206323*:
Constraining patent/regulatory exclusivity:
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.

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength8MG;54.3MG
Approval Date:Jun 22, 2015TE:RLD:No
Patent:  Start TrialPatent Expiration:Jan 3, 2032Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF COUGH AND SYMPTOMS ASSOCIATED WITH UPPER RESPIRATORY ALLERGIES OR A COMMON COLD WITH CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE ORALLY ADMINISTERED EXTENDED RELEASE TABLETS
Patent:  Start TrialPatent Expiration:Jan 3, 2032Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 206323

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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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 verification 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.