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LUMASON Drug Patent Profile

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

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

This drug has thirty-seven patent family members in twelve countries.

The generic ingredient in LUMASON is sulfur hexafluoride lipid-type a microspheres. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the sulfur hexafluoride lipid-type a microspheres profile page.

DrugPatentWatch^® Generic Entry Outlook for Lumason

Lumason was eligible for patent challenges on October 10, 2018.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 6, 2038. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for LUMASON

International Patents:	37
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	34
Clinical Trials:	31
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for LUMASON
What excipients (inactive ingredients) are in LUMASON?	LUMASON excipients list
DailyMed Link:	LUMASON at DailyMed

Drug patent expirations by year for LUMASON

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

Generic Entry Date for LUMASON^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up NDA: 203684 Dosage: FOR SUSPENSION;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 LUMASON

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

Sponsor	Phase
Milton S. Hershey Medical Center	Early Phase 1
Mayo Clinic	Phase 2
Thomas Jefferson University	Phase 2

See all LUMASON clinical trials

Pharmacology for LUMASON

Drug Class	Contrast Agent for Ultrasound Imaging
Mechanism of Action	Ultrasound Contrast Activity

US Patents and Regulatory Information for LUMASON

LUMASON is protected by five US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of LUMASON is ⤷ Sign Up.

This potential generic entry date is based on patent ⤷ Sign Up.
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 LUMASON

Freeze-dried formulation for gas-filled microvesicles
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: USE IN ADULT AND PEDIATRIC PATIENTS WITH SUBOPTIMAL ECHOCARDIOGRAMS TO OPACIFY THE LEFT VENTRICULAR CHAMBER AND TO IMPROVE THE DELINEATION OF THE LEFT VENTRICULAR ENDOCARDIAL BORDER

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: USE IN ULTRASONOGRAPHY OF THE URINARY TRACT IN PEDIATRIC PATIENTS FOR THE EVALUATION OF SUSPECTED OR KNOWN VESICOURETERAL REFLUX

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: USE WITH ULTRASOUND OF THE LIVER IN ADULT AND PEDIATRIC PATIENTS TO CHARACTERIZE FOCAL LIVER LESIONS

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bracco	LUMASON	sulfur hexafluoride lipid-type a microspheres	FOR SUSPENSION;INTRAVENOUS	203684-001	Oct 15, 2014		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Bracco	LUMASON	sulfur hexafluoride lipid-type a microspheres	FOR SUSPENSION;INTRAVENOUS	203684-001	Oct 15, 2014		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Bracco	LUMASON	sulfur hexafluoride lipid-type a microspheres	FOR SUSPENSION;INTRAVENOUS	203684-001	Oct 15, 2014		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for LUMASON

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bracco	LUMASON	sulfur hexafluoride lipid-type a microspheres	FOR SUSPENSION;INTRAVENOUS	203684-001	Oct 15, 2014	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for LUMASON

When does loss-of-exclusivity occur for LUMASON?

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

Australia

Patent: 19298652
Patent: Freeze-dried formulation for gas-filled microvesicles
Estimated Expiration: ⤷ Sign Up

Brazil

Patent: 2020022883
Patent: formulação liofilizada para microvesículas preenchidas com gás
Estimated Expiration: ⤷ Sign Up

Canada

Patent: 98380
Patent: FORMULATION LYOPHILISEE POUR MICROVESICULES REMPLIES DE GAZ (FREEZE-DRIED FORMULATION FOR GAS-FILLED MICROVESICLES)
Estimated Expiration: ⤷ Sign Up

China

Patent: 2165959
Patent: 用于充气微泡的冻干制剂 (FREEZE-DRIED FORMULATION FOR GAS-FILLED MICROVESICLES)
Estimated Expiration: ⤷ Sign Up

European Patent Office

Patent: 17777
Patent: FORMULATION LYOPHILISÉE POUR MICROVÉSICULES REMPLIES DE GAZ (FREEZE-DRIED FORMULATION FOR GAS-FILLED MICROVESICLES)
Estimated Expiration: ⤷ Sign Up

Japan

Patent: 28299
Estimated Expiration: ⤷ Sign Up

Patent: 21529730
Patent: ガスが充填された微小胞のための凍結乾燥製剤
Estimated Expiration: ⤷ Sign Up

Mexico

Patent: 20012604
Patent: FORMULACION CONGELADA PARA MICROVESICULAS LLENAS DE GAS. (FREEZE-DRIED FORMULATION FOR GAS-FILLED MICROVESICLES.)
Estimated Expiration: ⤷ Sign Up

Singapore

Patent: 202010539R
Patent: FREEZE-DRIED FORMULATION FOR GAS-FILLED MICROVESICLES
Estimated Expiration: ⤷ Sign Up

South Korea

Patent: 2556398
Estimated Expiration: ⤷ Sign Up

Patent: 210029712
Patent: 기체-충전 미세소포를 위한 동결-건조 제제
Estimated Expiration: ⤷ Sign Up

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 LUMASON around the world.

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Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2020229642		⤷ Sign Up
Brazil	112020022883	formulação liofilizada para microvesículas preenchidas com gás	⤷ Sign Up
Hungary	225495	GAS MIXTURES USEFUL AS ULTRASOUND CONTRAST MEDIA	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for LUMASON

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0619743	C300061	Netherlands	⤷ Sign Up	PRODUCT NAME: ZWAVELHEXAFLUORIDE; REGISTRATION NO/DATE: EU/1/01/177/001-002 20010326
1556389	16C0004	France	⤷ Sign Up	PRODUCT NAME: CEFTOLOZANE,EVENTUELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE,PLUS PARTICULIEREMENT UN SEL D'ACIDE SULFURIQUE; REGISTRATION NO/DATE: EU/1/15/1032 20150922
0619743	01C0036	France	⤷ Sign Up	PRODUCT NAME: SULPHUR HEXAFLUORIDE; REGISTRATION NO/DATE: EU/1/01/177/001 20010326
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description