EXEM FOAM KIT Drug Patent Profile

Which patents cover Exem Foam Kit, and what generic alternatives are available?

Exem Foam Kit is a drug marketed by Giskit and is included in one NDA. There are three patents protecting this drug.

This drug has six patent family members in six countries.

The generic ingredient in EXEM FOAM KIT is air polymer-type a. There are thirty-seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the air polymer-type a profile page.

DrugPatentWatch^® Generic Entry Outlook for Exem Foam Kit

Exem Foam Kit will be eligible for patent challenges on November 7, 2023. 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 November 7, 2024. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for EXEM FOAM KIT

International Patents:	6
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
DailyMed Link:	EXEM FOAM KIT at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for EXEM FOAM KIT

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

NDA:

212279

Dosage:

FOAM;INTRAUTERINE

^*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 EXEM FOAM KIT

EXEM FOAM KIT is protected by three 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.

Patents protecting EXEM FOAM KIT

FDA Regulatory Exclusivity protecting EXEM FOAM KIT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Giskit	EXEM FOAM KIT	air polymer-type a	FOAM;INTRAUTERINE	212279-001	Nov 7, 2019		RX	Yes	Yes			Y
Giskit	EXEM FOAM KIT	air polymer-type a	FOAM;INTRAUTERINE	212279-001	Nov 7, 2019		RX	Yes	Yes
Giskit	EXEM FOAM KIT	air polymer-type a	FOAM;INTRAUTERINE	212279-001	Nov 7, 2019		RX	Yes	Yes			Y
Giskit	EXEM FOAM KIT	air polymer-type a	FOAM;INTRAUTERINE	212279-001	Nov 7, 2019		RX	Yes	Yes			Y

International Patents for EXEM FOAM KIT

See the table below for patents covering EXEM FOAM KIT around the world.

Country	Patent Number	Title	Estimated Expiration
Poland	2488211
Netherlands	2003660
Denmark	2488211
World Intellectual Property Organization (WIPO)	2011046437
European Patent Office	2488211	Composition et procédé d'imagerie médicale de cavités corporelles (Composition and method for medical imaging of body cavities)
Spain	2529564