POSLUMA Drug Patent Profile
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When do Posluma patents expire, and when can generic versions of Posluma launch?
Posluma is a drug marketed by Blue Earth and is included in one NDA. There are six patents protecting this drug.
This drug has ninety-one patent family members in twenty-one countries.
The generic ingredient in POSLUMA is flotufolastat f-18 gallium. One supplier is listed for this compound. Additional details are available on the flotufolastat f-18 gallium profile page.
DrugPatentWatch® Generic Entry Outlook for Posluma
Posluma will be eligible for patent challenges on May 25, 2027. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be August 23, 2038. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
AI Deep Research
Questions you can ask:
- What is the 5 year forecast for POSLUMA?
- What are the global sales for POSLUMA?
- What is Average Wholesale Price for POSLUMA?
Summary for POSLUMA
| International Patents: | 91 |
| US Patents: | 6 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Clinical Trials: | 5 |
| Drug Prices: | Drug price information for POSLUMA |
| What excipients (inactive ingredients) are in POSLUMA? | POSLUMA excipients list |
| DailyMed Link: | POSLUMA at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for POSLUMA
Generic Entry Date for POSLUMA*:
Constraining patent/regulatory exclusivity:
NDA:
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 POSLUMA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Icahn School of Medicine at Mount Sinai | PHASE2 |
| University of Florida | PHASE2 |
| National Cancer Institute (NCI) | PHASE2 |
Pharmacology for POSLUMA
| Drug Class | Radioactive Diagnostic Agent |
| Mechanism of Action | Positron Emitting Activity |
US Patents and Regulatory Information for POSLUMA
POSLUMA is protected by eight US patents and one FDA Regulatory Exclusivity.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of POSLUMA is ⤷ Start Trial.
This potential generic entry date is based on patent ⤷ Start 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.
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Blue Earth | POSLUMA | flotufolastat f-18 gallium | SOLUTION;INTRAVENOUS | 216023-001 | May 25, 2023 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| Blue Earth | POSLUMA | flotufolastat f-18 gallium | SOLUTION;INTRAVENOUS | 216023-001 | May 25, 2023 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| Blue Earth | POSLUMA | flotufolastat f-18 gallium | SOLUTION;INTRAVENOUS | 216023-001 | May 25, 2023 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| Blue Earth | POSLUMA | flotufolastat f-18 gallium | SOLUTION;INTRAVENOUS | 216023-001 | May 25, 2023 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| Blue Earth | POSLUMA | flotufolastat f-18 gallium | SOLUTION;INTRAVENOUS | 216023-001 | May 25, 2023 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| Blue Earth | POSLUMA | flotufolastat f-18 gallium | SOLUTION;INTRAVENOUS | 216023-001 | May 25, 2023 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| Blue Earth | POSLUMA | flotufolastat f-18 gallium | SOLUTION;INTRAVENOUS | 216023-001 | May 25, 2023 | 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 |
International Patents for POSLUMA
When does loss-of-exclusivity occur for POSLUMA?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Australia
Patent: 18308699
Estimated Expiration: ⤷ Start Trial
Patent: 24200440
Estimated Expiration: ⤷ Start Trial
Brazil
Patent: 2020001785
Estimated Expiration: ⤷ Start Trial
Canada
Patent: 71315
Estimated Expiration: ⤷ Start Trial
China
Patent: 1132700
Estimated Expiration: ⤷ Start Trial
Denmark
Patent: 58194
Estimated Expiration: ⤷ Start Trial
Eurasian Patent Organization
Patent: 2090370
Estimated Expiration: ⤷ Start Trial
European Patent Office
Patent: 58194
Estimated Expiration: ⤷ Start Trial
Patent: 00640
Estimated Expiration: ⤷ Start Trial
Patent: 24378
Estimated Expiration: ⤷ Start Trial
Finland
Patent: 58194
Estimated Expiration: ⤷ Start Trial
Hungary
Patent: 70098
Estimated Expiration: ⤷ Start Trial
Israel
Patent: 2291
Patent: חומרים המסומנים ברדיואיזוטופים דו אופניים ותרופות (Dual mode radiotracer and -therapeutics)
Estimated Expiration: ⤷ Start Trial
Patent: 8092
Patent: חומרים המסומנים ברדיואיזוטופים דו אופניים ותרופות (Dual mode radiotracer and –therapeutics)
Estimated Expiration: ⤷ Start Trial
Japan
Patent: 59372
Estimated Expiration: ⤷ Start Trial
Patent: 20528461
Patent: デュアルモードの放射性トレーサーおよび療法剤
Estimated Expiration: ⤷ Start Trial
Patent: 22101601
Patent: デュアルモードの放射性トレーサーおよび療法剤
Estimated Expiration: ⤷ Start Trial
Mexico
Patent: 20000352
Patent: MARCADOR RADIOACTIVO DE MODO DUAL Y TERAPEUTICOS. (DUAL MODE RADIOTRACER AND -THERAPEUTICS.)
Estimated Expiration: ⤷ Start Trial
Patent: 23007914
Patent: MARCADOR RADIOACTIVO DE MODO DUAL Y TERAPEUTICOS. (DUAL MODE RADIOTRACER AND -THERAPEUTICS.)
Estimated Expiration: ⤷ Start Trial
New Zealand
Patent: 0537
Patent: Dual mode radiotracer and -therapeutics
Estimated Expiration: ⤷ Start Trial
Poland
Patent: 58194
Estimated Expiration: ⤷ Start Trial
Portugal
Patent: 58194
Estimated Expiration: ⤷ Start Trial
Singapore
Patent: 202000725W
Patent: DUAL MODE RADIOTRACER AND -THERAPEUTICS
Estimated Expiration: ⤷ Start Trial
South Africa
Patent: 2000467
Patent: DUAL MODE RADIOTRACER AND -THERAPEUTICS
Estimated Expiration: ⤷ Start Trial
South Korea
Patent: 2752620
Estimated Expiration: ⤷ Start Trial
Patent: 200064057
Patent: 이중 모드 방사성 트레이서 및 치료법
Estimated Expiration: ⤷ Start Trial
Patent: 240027896
Patent: 이중 모드 방사성 트레이서 및 치료법 (DUAL MODE RADIOTRACER AND -THERAPEUTICS)
Estimated Expiration: ⤷ Start Trial
Spain
Patent: 11272
Estimated Expiration: ⤷ Start 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.
See the table below for additional patents covering POSLUMA around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Australia | 2018308699 | ⤷ Start Trial | |
| Australia | 2024200440 | ⤷ Start Trial | |
| Brazil | 112020001785 | ⤷ Start Trial | |
| Canada | 3071315 | ⤷ Start Trial | |
| China | 111132700 | ⤷ Start Trial | |
| Denmark | 3658194 | ⤷ Start Trial | |
| Eurasian Patent Organization | 202090370 | ⤷ Start Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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.
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