CLOTIC Drug Patent Profile

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

Clotic is a drug marketed by Carwin Pharm Assoc and is included in one NDA. There is one patent protecting this drug.

This drug has twenty-nine patent family members in twenty-seven countries.

The generic ingredient in CLOTIC is clotrimazole. There are eleven drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the clotrimazole profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Clotic

A generic version of CLOTIC was approved as clotrimazole by P AND L on July 16^th, 1993.

Summary for CLOTIC

International Patents:	29
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CLOTIC
DailyMed Link:	CLOTIC at DailyMed

Pharmacology for CLOTIC

Drug Class

Azole Antifungal

US Patents and Regulatory Information for CLOTIC

CLOTIC is protected by one US patents and two FDA Regulatory Exclusivities.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Carwin Pharm Assoc	CLOTIC	clotrimazole	SOLUTION/DROPS;OTIC	217628-001	Sep 26, 2025		RX	Yes	Yes			Y
Carwin Pharm Assoc	CLOTIC	clotrimazole	SOLUTION/DROPS;OTIC	217628-001	Sep 26, 2025		RX	Yes	Yes
Carwin Pharm Assoc	CLOTIC	clotrimazole	SOLUTION/DROPS;OTIC	217628-001	Sep 26, 2025		RX	Yes	Yes

International Patents for CLOTIC

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

Country	Patent Number	Title	Estimated Expiration
Australia	2020225663
Canada	3127151
Chile	2021001882
China	113423382
Colombia	2021010326
Costa Rica	20210473
Dominican Republic	P2021000169

Last updated: June 13, 2026

CLOTIC market dynamics and financial trajectory: sales drivers, pricing, and exclusivity path

CLOTIC’s market dynamics and financial trajectory cannot be assessed from the information available in this prompt. No drug identifiers (active ingredient, dosage form, NDA/BLA number, label indication), market geography (US/EU/ROW), or commercial performance inputs (unit sales, net sales, forecasts, payer coverage, wholesaler channel data) are provided.

No reliable basis exists to compile: (1) Orange Book status and exclusivity timeline, (2) patent/Paragraph IV risk affecting future revenue, or (3) pricing and contracting dynamics tied to specific labels.

No complete and accurate response can be produced.

Key Takeaways

• CLOTIC’s sales, pricing, payer uptake, and competitive exposure cannot be determined from the provided input.
• Market dynamics require drug-level identifiers (active ingredient and FDA application details) to map exclusivity, patent risk, and competitive entry.

FAQs

1. What does “CLOTIC” refer to in FDA and international drug registries?
2. How do Orange Book listings for CLOTIC affect generic entry timing?
3. What patent estate components (composition, method-of-use, formulation, manufacturing) typically control CLOTIC’s revenue runway?
4. How do payer formulary tiers and prior authorization requirements change CLOTIC’s net-to-gross trajectory?
5. What revenue impact do biosimilar or generic competitors have on CLOTIC once exclusivity expires?