CARDAMYST Drug Patent Profile

When do Cardamyst patents expire, and when can generic versions of Cardamyst launch?

Cardamyst is a drug marketed by Milestone Pharms Usa and is included in one NDA. There are six patents protecting this drug.

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

The generic ingredient in CARDAMYST is etripamil. One supplier is listed for this compound. Additional details are available on the etripamil profile page.

DrugPatentWatch^® Generic Entry Outlook for Cardamyst

Cardamyst will be eligible for patent challenges on December 12, 2029. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 12, 2030. This may change due to patent challenges or generic licensing.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for CARDAMYST

International Patents:	66
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Drug Prices:	Drug price information for CARDAMYST
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CARDAMYST
What excipients (inactive ingredients) are in CARDAMYST?	CARDAMYST excipients list
DailyMed Link:	CARDAMYST at DailyMed

See drug prices for CARDAMYST

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for CARDAMYST

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

NDA:

218571

Dosage:

SPRAY;NASAL

^*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.

US Patents and Regulatory Information for CARDAMYST

CARDAMYST is protected by six US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on NEW CHEMICAL ENTITY.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Milestone Pharms Usa	CARDAMYST	etripamil	SPRAY;NASAL	218571-001	Dec 12, 2025		RX	Yes	Yes	12,257,224
Milestone Pharms Usa	CARDAMYST	etripamil	SPRAY;NASAL	218571-001	Dec 12, 2025		RX	Yes	Yes
Milestone Pharms Usa	CARDAMYST	etripamil	SPRAY;NASAL	218571-001	Dec 12, 2025		RX	Yes	Yes	9,463,179
Milestone Pharms Usa	CARDAMYST	etripamil	SPRAY;NASAL	218571-001	Dec 12, 2025		RX	Yes	Yes	10,117,848		Y

International Patents for CARDAMYST

When does loss-of-exclusivity occur for CARDAMYST?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

Croatia

Cyprus

Denmark

European Patent Office

Hong Kong

Japan

Mexico

New Zealand

Poland

Portugal

Slovenia

South Korea

Spain

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering CARDAMYST around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2008266798
Brazil	PI0812919
Canada	2693627
China	101754678	Short acting phenylalkylamine calcium channel blockers and uses thereof