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Last Updated: March 19, 2024

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DEFINITY Drug Patent Profile


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Which patents cover Definity, and what generic alternatives are available?

Definity is a drug marketed by Lantheus Medcl and is included in one NDA. There are nine patents protecting this drug.

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

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

DrugPatentWatch® Generic Entry Outlook for Definity

Definity was eligible for patent challenges on July 31, 2005.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 4, 2037. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for DEFINITY
Drug patent expirations by year for DEFINITY
Drug Prices for DEFINITY

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DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for DEFINITY
Generic Entry Date for DEFINITY*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
INJECTABLE;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 DEFINITY

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

SponsorPhase
InSightecPhase 2
M.D. Anderson Cancer CenterPhase 2
Merck Sharp & Dohme LLCPhase 2

See all DEFINITY clinical trials

Pharmacology for DEFINITY

US Patents and Regulatory Information for DEFINITY

DEFINITY is protected by seven US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of DEFINITY is ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

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 DEFINITY

Lipid-encapsulated gas microsphere compositions and related methods
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF USING THE DRUG SUBSTANCE/DRUG PRODUCT FOR ULTRASOUND IMAGING

Methods for making ultrasound contrast agents
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF USING THE DRUG SUBSTANCE/DRUG PRODUCT FOR ULTRASOUND IMAGING

Methods and devices for preparation of ultrasound contrast agents
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF USING THE DRUG SUBSTANCE/DRUG PRODUCT FOR ULTRASOUND IMAGING

Methods for making ultrasound contrast agents
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF USING THE DRUG SUBSTANCE/DRUG PRODUCT FOR ULTRASOUND IMAGING


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF USING THE DRUG SUBSTANCE/DRUG PRODUCT FOR ULTRASOUND IMAGING


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF USING THE DRUG SUBSTANCE/DRUG PRODUCT FOR ULTRASOUND IMAGING

Methods for making ultrasound contrast agents
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF USING THE DRUG SUBSTANCE/DRUG PRODUCT FOR ULTRASOUND IMAGING

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lantheus Medcl DEFINITY perflutren INJECTABLE;INTRAVENOUS 021064-001 Jul 31, 2001 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Lantheus Medcl DEFINITY perflutren INJECTABLE;INTRAVENOUS 021064-001 Jul 31, 2001 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Lantheus Medcl DEFINITY perflutren INJECTABLE;INTRAVENOUS 021064-001 Jul 31, 2001 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Lantheus Medcl DEFINITY RT perflutren INJECTABLE;INTRAVENOUS 021064-002 Nov 17, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Lantheus Medcl DEFINITY RT perflutren INJECTABLE;INTRAVENOUS 021064-002 Nov 17, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Lantheus Medcl DEFINITY RT perflutren INJECTABLE;INTRAVENOUS 021064-002 Nov 17, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Lantheus Medcl DEFINITY RT perflutren INJECTABLE;INTRAVENOUS 021064-002 Nov 17, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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 DEFINITY

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Lantheus Medcl DEFINITY perflutren INJECTABLE;INTRAVENOUS 021064-001 Jul 31, 2001 ⤷  Try a Trial ⤷  Try a Trial
Lantheus Medcl DEFINITY perflutren INJECTABLE;INTRAVENOUS 021064-001 Jul 31, 2001 ⤷  Try a Trial ⤷  Try a Trial
Lantheus Medcl DEFINITY perflutren INJECTABLE;INTRAVENOUS 021064-001 Jul 31, 2001 ⤷  Try a Trial ⤷  Try a Trial
Lantheus Medcl DEFINITY perflutren INJECTABLE;INTRAVENOUS 021064-001 Jul 31, 2001 ⤷  Try a Trial ⤷  Try a Trial
Lantheus Medcl DEFINITY perflutren INJECTABLE;INTRAVENOUS 021064-001 Jul 31, 2001 ⤷  Try a Trial ⤷  Try a Trial
Lantheus Medcl DEFINITY perflutren INJECTABLE;INTRAVENOUS 021064-001 Jul 31, 2001 ⤷  Try a Trial ⤷  Try a Trial
Lantheus Medcl DEFINITY perflutren INJECTABLE;INTRAVENOUS 021064-001 Jul 31, 2001 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for DEFINITY

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Lantheus EU Limited Luminity perflutren EMEA/H/C/000654
This medicinal product is for diagnostic use only.Luminity is an ultrasound contrast-enhancing agent for use in patients in whom non-contrast echocardiography was suboptimal (suboptimal is considered to indicate that at least two of six segments in the 4- or 2-chamber view of the ventricular border were not evaluable) and who have suspected or established coronary artery disease, to provide opacification of cardiac chambers and improvement of left ventricular endocardial border delineation at both rest and stress.
Authorised no no no 2006-09-20
GE Healthcare AS Optison perflutren EMEA/H/C/000166
This medicinal product is for diagnostic use only.Optison is a transpulmonary echocardiographic contrast agent for use in patients with suspected or established cardiovascular disease to provide opacification of cardiac chambers, enhance left-ventricular-endocardial-border delineation with resulting improvement in wall-motion visualisation.Optison should only be used in patients where the study without contrast enhancement is inconclusive.
Authorised no no no 1998-05-17
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for DEFINITY

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

Country Patent Number Title Estimated Expiration
European Patent Office 0740528 MICROSPHERES GAZEUSES POUR APPLICATION TOPIQUE ET SOUS-CUTANEE (GAS MICROSPHERES FOR TOPICAL AND SUBCUTANEOUS APPLICATION) ⤷  Try a Trial
Spain 2207687 ⤷  Try a Trial
Brazil 112018072342 métodos e dispositivos para preparação de agentes de contraste de ultrassom ⤷  Try a Trial
European Patent Office 1104678 ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 9217514 ⤷  Try a Trial
Spain 2225878 ⤷  Try a Trial
China 1098068 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for DEFINITY

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0712293 CA 2007 00027 Denmark ⤷  Try a Trial
0712293 91325 Luxembourg ⤷  Try a Trial PRODUCT NMAE. LUMINITY; REGISTRATION DATE: 20060920
0712293 SPC/GB07/031 United Kingdom ⤷  Try a Trial PRODUCT NAME: PERFLUTREN-CONTAINING LIPID MICROSPHERES; REGISTERED: UK EU/1/06/361/001 20060920
0712293 C300267 Netherlands ⤷  Try a Trial PRODUCT NAME: PERFLUTREN BEVATTENDE LIPIDE-MICROBOLLEN; REGISTRATION NO/DATE: EU/1/06/361/001 20060920
0712293 SPC018/2007 Ireland ⤷  Try a Trial SPC018/2007: 20071012, EXPIRES: 20190519
0712293 300267 Netherlands ⤷  Try a Trial 300267, 20140520, EXPIRES: 20190519
0712293 0790017-8 Sweden ⤷  Try a Trial PRODUCT NAME: LIPIDMIKROSFAERER INNEHALLANDE PERFLUTREN; REG. NO/DATE: EU/1/06/361/001 20060920
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.