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. It is available from one supplier. 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. One supplier is listed for this compound. Additional details are available on the articaine hydrochloride profile page.
The generic ingredient in CYKLX is articaine hydrochloride. There are seven drug master file entries for this compound. One supplier is listed 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*:
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.
Pharmacology for NDA: 218643
| Physiological Effect | Local Anesthesia |
Suppliers and Packaging for NDA: 218643
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CYKLX | articaine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 218643 | NDA | American Genomics, LLC | 87047-7852 | 87047-7852-1 | 10 POUCH in 1 CARTON (87047-7852-1) / 5 VIAL, SINGLE-DOSE in 1 POUCH / .4 mL in 1 VIAL, SINGLE-DOSE |
| CYKLX | articaine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 218643 | NDA | American Genomics, LLC | 87047-7852 | 87047-7852-2 | 2 POUCH in 1 CARTON (87047-7852-2) / 5 VIAL, SINGLE-DOSE in 1 POUCH / .4 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | EQ 8% BASE | ||||
| Approval Date: | Aug 15, 2025 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Aug 15, 2028 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Mar 27, 2039 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | METHOD OF ANESTHETIZING AN OCULAR SURFACE VIA TOPICAL ADMINISTRATION PRIOR TO OCULAR PROCEDURES AND/OR INTRAOCULAR INJECTIONS | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Mar 27, 2039 | Product Flag? | Y | Substance 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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