Last Updated: August 9, 2026

Details for New Drug Application (NDA): 218643


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NDA 218643 describes CYKLX, which is a drug marketed by Thea Pharma and is included in one NDA. There are three patents protecting this drug. Additional details are available on the CYKLX profile page.

The generic ingredient in CYKLX is articaine hydrochloride. There are seven drug master file entries for this compound. Additional details are available on the articaine hydrochloride profile page.
Summary for 218643
Tradename:CYKLX
Applicant:Thea Pharma
Ingredient:articaine hydrochloride
Patents:3
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 218643
Generic Entry Date for 218643*:

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Constraining patent/regulatory exclusivity:

NEW PRODUCT

Dosage:

SOLUTION/DROPS;OPHTHALMIC

*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:DISCNDosage:SOLUTION/DROPS;OPHTHALMICStrengthEQ 8% BASE
Approval Date:Aug 15, 2025TE:RLD:Yes
Regulatory Exclusivity Expiration:Aug 15, 2028
Regulatory Exclusivity Use:NEW PRODUCT
Patent:⤷  Start TrialPatent Expiration:Mar 27, 2039Product Flag?YSubstance Flag?Delist Request?
Patented Use:METHOD OF ANESTHETIZING AN OCULAR SURFACE VIA TOPICAL ADMINISTRATION PRIOR TO OCULAR PROCEDURES AND/OR INTRAOCULAR INJECTIONS
Patent:⤷  Start TrialPatent Expiration:Mar 27, 2039Product Flag?YSubstance Flag?Delist Request?
Patented Use:METHOD OF ANESTHETIZING AN OCULAR SURFACE VIA TOPICAL ADMINISTRATION PRIOR TO OCULAR PROCEDURES AND/OR INTRAOCULAR INJECTIONS

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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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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.

 
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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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