DrugPatentWatch Database Preview
DEFINITY Drug 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 five patents protecting this drug.
This drug has forty-two patent family members in fourteen 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: | 42 |
| US Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 38 |
| Clinical Trials: | 52 |
| Patent Applications: | 3,413 |
| 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 Generic Entry Opportunity 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 |
|---|---|
| Kibo Nam | Phase 2/Phase 3 |
| Thomas Jefferson University | Early Phase 1 |
| National Cancer Institute (NCI) | 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
| 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 | Start Trial | Start Trial | Start Trial | ||||
| Lantheus Medcl | DEFINITY RT | perflutren | INJECTABLE;INTRAVENOUS | 021064-002 | Nov 17, 2020 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Lantheus Medcl | DEFINITY | perflutren | INJECTABLE;INTRAVENOUS | 021064-001 | Jul 31, 2001 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Lantheus Medcl | DEFINITY RT | perflutren | INJECTABLE;INTRAVENOUS | 021064-002 | Nov 17, 2020 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Lantheus Medcl | DEFINITY | perflutren | INJECTABLE;INTRAVENOUS | 021064-001 | Jul 31, 2001 | RX | Yes | Yes | Start Trial | Start Trial | Start 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 | Start Trial | Start Trial |
| Lantheus Medcl | DEFINITY | perflutren | INJECTABLE;INTRAVENOUS | 021064-001 | Jul 31, 2001 | Start Trial | Start Trial |
| Lantheus Medcl | DEFINITY | perflutren | INJECTABLE;INTRAVENOUS | 021064-001 | Jul 31, 2001 | Start Trial | Start Trial |
| Lantheus Medcl | DEFINITY | perflutren | INJECTABLE;INTRAVENOUS | 021064-001 | Jul 31, 2001 | Start Trial | Start Trial |
| Lantheus Medcl | DEFINITY | perflutren | INJECTABLE;INTRAVENOUS | 021064-001 | Jul 31, 2001 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for DEFINITY
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Germany | 69432358 | Start Trial |
| World Intellectual Property Organization (WIPO) | 9936104 | Start Trial |
| Australia | 709562 | Start Trial |
| Japan | 3299745 | Start Trial |
| Australia | 8420698 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for DEFINITY
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0712293 | CA 2007 00027 | Denmark | Start Trial | |
| 0712293 | SPC018/2007 | Ireland | Start Trial | SPC018/2007: 20071012, EXPIRES: 20190519 |
| 0712293 | SPC/GB07/031 | United Kingdom | Start Trial | PRODUCT NAME: PERFLUTREN-CONTAINING LIPID MICROSPHERES; REGISTERED: UK EU/1/06/361/001 20060920 |
| 0712293 | C300267 | Netherlands | Start Trial | PRODUCT NAME: PERFLUTREN BEVATTENDE LIPIDE-MICROBOLLEN; REGISTRATION NO/DATE: EU/1/06/361/001 20060920 |
| 0712293 | 91325 | Luxembourg | Start Trial | PRODUCT NMAE. LUMINITY; REGISTRATION DATE: 20060920 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
