LUMISIGHT Drug Patent Profile

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

Lumisight is a drug marketed by Lumicell and is included in one NDA. There are six patents protecting this drug.

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

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

DrugPatentWatch^® Generic Entry Outlook for Lumisight

Lumisight will be eligible for patent challenges on April 17, 2028. 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 1, 2030. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for LUMISIGHT

International Patents:	23
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	1
What excipients (inactive ingredients) are in LUMISIGHT?	LUMISIGHT excipients list
DailyMed Link:	LUMISIGHT at DailyMed

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

Constraining patent/regulatory exclusivity:

11,592,396

NDA:

214511

Dosage:

POWDER;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.

Recent Clinical Trials for LUMISIGHT

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
National Institutes of Health (NIH)	EARLY_PHASE1
National Heart, Lung, and Blood Institute (NHLBI)	EARLY_PHASE1
Massachusetts General Hospital	EARLY_PHASE1

See all LUMISIGHT clinical trials

US Patents and Regulatory Information for LUMISIGHT

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

This potential generic entry date is based on patent 11,592,396.

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
Lumicell	LUMISIGHT	pegulicianine acetate	POWDER;INTRAVENOUS	214511-001	Apr 17, 2024		RX	Yes	Yes	10,285,759
Lumicell	LUMISIGHT	pegulicianine acetate	POWDER;INTRAVENOUS	214511-001	Apr 17, 2024		RX	Yes	Yes
Lumicell	LUMISIGHT	pegulicianine acetate	POWDER;INTRAVENOUS	214511-001	Apr 17, 2024		RX	Yes	Yes	9,155,471
Lumicell	LUMISIGHT	pegulicianine acetate	POWDER;INTRAVENOUS	214511-001	Apr 17, 2024		RX	Yes	Yes	9,763,577		Y	Y

International Patents for LUMISIGHT

When does loss-of-exclusivity occur for LUMISIGHT?

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

Australia

Canada

European Patent Office

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 LUMISIGHT around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2646057	PROCÉDÉS ET SYSTÈMES DESTINÉS À IDENTIFIER SPATIALEMENT DES CELLULES ANORMALES (METHODS AND SYSTEMS FOR SPATIALLY IDENTIFYING ABNORMAL CELLS)
Australia	2016277654	METHODS AND SYSTEMS FOR SPATIALLY IDENTIFYING ABNORMAL CELLS
Australia	2014236561	Medical imaging device and methods of use
Japan	7273873