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 eight patents protecting this drug.
This drug has sixty-four 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
Summary for DEFINITY
| International Patents: | 64 |
| US Patents: | 6 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 67 |
| Clinical Trials: | 63 |
| Patent Applications: | 2,913 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for DEFINITY |
| What excipients (inactive ingredients) are in DEFINITY? | DEFINITY excipients list |
| DailyMed Link: | DEFINITY at DailyMed |
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
| Sponsor | Phase |
|---|---|
| InSightec | Phase 2 |
| M.D. Anderson Cancer Center | Phase 2 |
| Merck Sharp & Dohme LLC | Phase 2 |
Pharmacology for DEFINITY
| Drug Class | Contrast Agent for Ultrasound Imaging |
| Mechanism of Action | Ultrasound Contrast Activity |
US Patents and Regulatory Information for DEFINITY
DEFINITY is protected by six 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
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 RT | perflutren | INJECTABLE;INTRAVENOUS | 021064-002 | Nov 17, 2020 | 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 | Y | Y | ⤷ 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 |
| >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 |
|---|---|---|---|
| Brazil | 112018074469 | métodos para produção de agentes de contraste de ultrassom | ⤷ Try a Trial |
| Malaysia | 137255 | PREPARATION OF A LIPID BLEND AND A PHOSPHOLIPID SUSPENSION CONTAINING THE LIPID BLEND | ⤷ Try a Trial |
| Canada | 2188557 | ⤷ Try a Trial | |
| Austria | 201217 | ⤷ 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 | SPC/GB07/031 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: PERFLUTREN-CONTAINING LIPID MICROSPHERES; REGISTERED: UK EU/1/06/361/001 20060920 |
| 0712293 | SPC018/2007 | Ireland | ⤷ Try a Trial | SPC018/2007: 20071012, EXPIRES: 20190519 |
| 0712293 | C300267 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: PERFLUTREN BEVATTENDE LIPIDE-MICROBOLLEN; REGISTRATION NO/DATE: EU/1/06/361/001 20060920 |
| 0712293 | CA 2007 00027 | Denmark | ⤷ Try a Trial | |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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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.
ISSN: 2162-2639
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