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Last Updated: November 21, 2024

ORAQIX Drug Patent Profile


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

Oraqix is a drug marketed by Dentsply Pharm and is included in one NDA.

The generic ingredient in ORAQIX is lidocaine; prilocaine. There are twenty-nine drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the lidocaine; prilocaine profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Oraqix

A generic version of ORAQIX was approved as lidocaine; prilocaine by FOUGERA PHARMS on August 18th, 2003.

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Summary for ORAQIX
Drug patent expirations by year for ORAQIX
Drug Prices for ORAQIX

See drug prices for ORAQIX

Recent Clinical Trials for ORAQIX

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Joanneum Research Forschungsgesellschaft mbHN/A
Dentsply InternationalPhase 4

See all ORAQIX clinical trials

Pharmacology for ORAQIX

US Patents and Regulatory Information for ORAQIX

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Dentsply Pharm ORAQIX lidocaine; prilocaine GEL;PERIODONTAL 021451-001 Dec 19, 2003 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for ORAQIX

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Recordati Ireland Ltd. Fortacin lidocaine, prilocaine EMEA/H/C/002693
Treatment of primary premature ejaculation in adult men.
Authorised no no no 2013-11-15
Plethora Pharma Solutions Limited Senstend lidocaine, prilocaine EMEA/H/C/005298
Senstend is indicated for the treatment of primary premature ejaculation in adult men.
Withdrawn no no no 2019-11-14
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for ORAQIX

See the table below for patents covering ORAQIX around the world.

Country Patent Number Title Estimated Expiration
Czech Republic 9703711 ⤷  Sign Up
China 1188407 ⤷  Sign Up
Canada 2222676 NOUVELLE COMPOSITION PHARMACEUTIQUE POSSEDANT UN EFFET ANESTHESIQUE (NEW PHARMACEUTICAL COMPOSITION WITH ANAESTHETIC EFFECT) ⤷  Sign Up
China 1149072 ⤷  Sign Up
>Country >Patent Number >Title >Estimated 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.