Piflufolastat f-18 - Generic Drug Details
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What are the generic sources for piflufolastat f-18 and what is the scope of freedom to operate?
Piflufolastat f-18
is the generic ingredient in one branded drug marketed by Progenics Pharms Inc and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.Piflufolastat f-18 has ninety-three patent family members in twenty-three countries.
One supplier is listed for this compound.
Summary for piflufolastat f-18
| International Patents: | 93 |
| US Patents: | 5 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 3 |
| Clinical Trials: | 1 |
| Patent Applications: | 77 |
| What excipients (inactive ingredients) are in piflufolastat f-18? | piflufolastat f-18 excipients list |
| DailyMed Link: | piflufolastat f-18 at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for piflufolastat f-18
Generic Entry Date for piflufolastat f-18*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION;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 piflufolastat f-18
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Lantheus Medical Imaging | Early Phase 1 |
| M.D. Anderson Cancer Center | Early Phase 1 |
Pharmacology for piflufolastat f-18
| Drug Class | Radioactive Diagnostic Agent |
| Mechanism of Action | Positron Emitting Activity |
US Patents and Regulatory Information for piflufolastat f-18
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Progenics Pharms Inc | PYLARIFY | piflufolastat f-18 | SOLUTION;INTRAVENOUS | 214793-001 | May 26, 2021 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Progenics Pharms Inc | PYLARIFY | piflufolastat f-18 | SOLUTION;INTRAVENOUS | 214793-001 | May 26, 2021 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Progenics Pharms Inc | PYLARIFY | piflufolastat f-18 | SOLUTION;INTRAVENOUS | 214793-001 | May 26, 2021 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Progenics Pharms Inc | PYLARIFY | piflufolastat f-18 | SOLUTION;INTRAVENOUS | 214793-001 | May 26, 2021 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Progenics Pharms Inc | PYLARIFY | piflufolastat f-18 | SOLUTION;INTRAVENOUS | 214793-001 | May 26, 2021 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Progenics Pharms Inc | PYLARIFY | piflufolastat f-18 | SOLUTION;INTRAVENOUS | 214793-001 | May 26, 2021 | 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 |
International Patents for piflufolastat f-18
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Japan | 7427703 | ⤷ Try a Trial | |
| Slovenia | 2097111 | ⤷ Try a Trial | |
| European Patent Office | 2942065 | HÉTÉRODIMÈRES D'ACIDE GLUTAMIQUE (HETERODIMERS OF GLUTAMIC ACID) | ⤷ Try a Trial |
| Hungary | E059436 | ⤷ Try a Trial | |
| European Patent Office | 4023624 | HÉTÉRODIMÈRES D'ACIDE GLUTAMIQUE (HETERODIMERS OF GLUTAMIC ACID) | ⤷ Try a Trial |
| Japan | 2010509358 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for piflufolastat f-18
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2318366 | 301250 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: PIFLUFOLASTAT (18F) OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/23/1746 20230725 |
| 2318366 | C20230027 00410 | Estonia | ⤷ Try a Trial | PRODUCT NAME: PIFLUFOLASTAAT (18F);REG NO/DATE: EU/1/23/1746 25.07.2023 |
| 2318366 | 37/2023 | Austria | ⤷ Try a Trial | PRODUCT NAME: PIFLUFOLASTAT (18F) ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/23/1746 (MITTEILUNG) 20230725 |
| 2318366 | CR 2023 00032 | Denmark | ⤷ Try a Trial | PRODUCT NAME: PIFLUFOLASTAT (18F) ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/23/1746 20230725 |
| 2318366 | 2023C/540 | Belgium | ⤷ Try a Trial | PRODUCT NAME: PIFLUFOLASTAT (18F) OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/23/1746 20230725 |
| 2318366 | LUC00323 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: PIFLUFOLASTAT (18F) OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; AUTHORISATION NUMBER AND DATE: EU/1/23/1746 20230725 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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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