DETECTNET Drug Patent Profile

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

Detectnet is a drug marketed by Radiomedix and is included in one NDA. There are three patents protecting this drug.

This drug has eleven patent family members in six countries.

The generic ingredient in DETECTNET is copper cu-64 dotatate. There are fifteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the copper cu-64 dotatate profile page.

DrugPatentWatch^® Generic Entry Outlook for Detectnet

Detectnet will be eligible for patent challenges on September 3, 2024. 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 September 3, 2027. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for DETECTNET

International Patents:	11
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
What excipients (inactive ingredients) are in DETECTNET?	DETECTNET excipients list
DailyMed Link:	DETECTNET at DailyMed

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

Constraining patent/regulatory exclusivity:

FOR USE WITH POSITRON EMISSION TOMOGRAPHY (PET) FOR LOCALIZATION OF SOMATOSTATIN RECEPTOR POSITIVE NEUROENDOCRINE TUMORS (NETS) IN ADULT PATIENTS

NDA:

213227

Dosage:

SOLUTION;INTRAVENOUS

^*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 DETECTNET

Drug Class	Radioactive Diagnostic Agent
Mechanism of Action	Positron Emitting Activity

US Patents and Regulatory Information for DETECTNET

DETECTNET is protected by three US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on FOR USE WITH POSITRON EMISSION TOMOGRAPHY (PET) FOR LOCALIZATION OF SOMATOSTATIN RECEPTOR POSITIVE NEUROENDOCRINE TUMORS (NETS) IN ADULT PATIENTS.

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 DETECTNET

FDA Regulatory Exclusivity protecting DETECTNET

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Radiomedix	DETECTNET	copper cu-64 dotatate	SOLUTION;INTRAVENOUS	213227-001	Sep 3, 2020		RX	Yes	Yes
Radiomedix	DETECTNET	copper cu-64 dotatate	SOLUTION;INTRAVENOUS	213227-001	Sep 3, 2020		RX	Yes	Yes
Radiomedix	DETECTNET	copper cu-64 dotatate	SOLUTION;INTRAVENOUS	213227-001	Sep 3, 2020		RX	Yes	Yes
Radiomedix	DETECTNET	copper cu-64 dotatate	SOLUTION;INTRAVENOUS	213227-001	Sep 3, 2020		RX	Yes	Yes
Radiomedix	DETECTNET	copper cu-64 dotatate	SOLUTION;INTRAVENOUS	213227-001	Sep 3, 2020		RX	Yes	Yes

International Patents for DETECTNET

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

Country	Patent Number	Title	Estimated Expiration
Hungary	E052723
Poland	3536346
Spain	2732823
European Patent Office	3536346	TRACEUR TEP POUR L'IMAGERIE DE TUMEURS NEURO-ENDOCRINES (PET TRACER FOR IMAGING OF NEUROENDOCRINE TUMORS)
Denmark	3536346