VIZAMYL Drug Patent Profile
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Which patents cover Vizamyl, and what generic alternatives are available?
Vizamyl is a drug marketed by Ge Healthcare and is included in one NDA. There are three patents protecting this drug.
This drug has eighty-four patent family members in twenty-five countries.
The generic ingredient in VIZAMYL is flutemetamol f-18. One supplier is listed for this compound. Additional details are available on the flutemetamol f-18 profile page.
DrugPatentWatch® Generic Entry Outlook for Vizamyl
Vizamyl was eligible for patent challenges on October 25, 2017.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be September 16, 2028. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
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Questions you can ask:
- What is the 5 year forecast for VIZAMYL?
- What are the global sales for VIZAMYL?
- What is Average Wholesale Price for VIZAMYL?
Summary for VIZAMYL
International Patents: | 84 |
US Patents: | 3 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 3 |
Clinical Trials: | 6 |
Patent Applications: | 99 |
Drug Prices: | Drug price information for VIZAMYL |
What excipients (inactive ingredients) are in VIZAMYL? | VIZAMYL excipients list |
DailyMed Link: | VIZAMYL at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for VIZAMYL
Generic Entry Date for VIZAMYL*:
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 VIZAMYL
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Yale University | Phase 1 |
University of Utah | Phase 2 |
University Hospital, Toulouse | Early Phase 1 |
Pharmacology for VIZAMYL
Drug Class | Radioactive Diagnostic Agent |
Mechanism of Action | Radiopharmaceutical Activity |
US Patents and Regulatory Information for VIZAMYL
VIZAMYL is protected by three US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of VIZAMYL is ⤷ Subscribe.
This potential generic entry date is based on patent 8,916,131.
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Ge Healthcare | VIZAMYL | flutemetamol f-18 | INJECTABLE;INTRAVENOUS | 203137-001 | Oct 25, 2013 | DISCN | Yes | No | 7,270,800 | ⤷ Subscribe | Y | Y | ⤷ Subscribe | ||
Ge Healthcare | VIZAMYL | flutemetamol f-18 | INJECTABLE;INTRAVENOUS | 203137-002 | Oct 25, 2013 | RX | Yes | Yes | 7,270,800 | ⤷ Subscribe | Y | Y | ⤷ Subscribe | ||
Ge Healthcare | VIZAMYL | flutemetamol f-18 | INJECTABLE;INTRAVENOUS | 203137-001 | Oct 25, 2013 | DISCN | Yes | No | 8,236,282 | ⤷ Subscribe | Y | Y | ⤷ Subscribe | ||
>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 VIZAMYL
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Ge Healthcare | VIZAMYL | flutemetamol f-18 | INJECTABLE;INTRAVENOUS | 203137-002 | Oct 25, 2013 | 7,351,401 | ⤷ Subscribe |
Ge Healthcare | VIZAMYL | flutemetamol f-18 | INJECTABLE;INTRAVENOUS | 203137-001 | Oct 25, 2013 | 7,351,401 | ⤷ Subscribe |
Ge Healthcare | VIZAMYL | flutemetamol f-18 | INJECTABLE;INTRAVENOUS | 203137-002 | Oct 25, 2013 | 8,236,282 | ⤷ Subscribe |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for VIZAMYL
When does loss-of-exclusivity occur for VIZAMYL?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Australia
Patent: 08292201
Patent: Radiopharmaceutical composition
Estimated Expiration: ⤷ Subscribe
Brazil
Patent: 0815129
Patent: COMPOSIÇÃO RADIOFARMACÊUTICA, E, MÉTODOS PARA PREPARAÇÃO DE UMA COMPOSIÇÃO RADIOFARMACÊUTICA, E PARA DETERMINAÇÃO DA PRESENÇA, LOCALIZAÇÃO E/OU QUANTIDADE DE UM OU MAIS DEPÓSITOS DE AMILÓIDE EM UM ÓRGÃO OU ÁREA DO CORPO DE UM INDIVÍDUO
Estimated Expiration: ⤷ Subscribe
Canada
Patent: 94084
Patent: COMPOSITION RADIOPHARMACEUTIQUE (RADIOPHARMACEUTICAL COMPOSITION)
Estimated Expiration: ⤷ Subscribe
China
Patent: 1790387
Patent: Radiopharmaceutical composition
Estimated Expiration: ⤷ Subscribe
Denmark
Patent: 82988
Estimated Expiration: ⤷ Subscribe
European Patent Office
Patent: 82988
Patent: COMPOSITION RADIOPHARMACEUTIQUE (RADIOPHARMACEUTICAL COMPOSITION)
Estimated Expiration: ⤷ Subscribe
Hong Kong
Patent: 46710
Patent: RADIOPHARMACEUTICAL COMPOSITION
Estimated Expiration: ⤷ Subscribe
Hungary
Patent: 500007
Estimated Expiration: ⤷ Subscribe
Israel
Patent: 3316
Patent: תכשיר רוקחי רדיואקטיבי המכיל תרכובת בנזוטיאזול מסומנת ראדיואקטיבית ונשא כשיר ביולוגית ,שיטה להכנת התכשיר ושיטה לדימות על ידי שימוש בו (Radiopharmaceutical composition comprising isotopically-labeled benzothiazole compound and a biocompatible carrier, a method for preparing the composition and a method of imaging using the same)
Estimated Expiration: ⤷ Subscribe
Japan
Patent: 67708
Estimated Expiration: ⤷ Subscribe
Patent: 10536931
Estimated Expiration: ⤷ Subscribe
Mexico
Patent: 10002196
Patent: COMPOSICION RADIOFARMACEUTICA. (RADIOPHARMACEUTICAL COMPOSITION.)
Estimated Expiration: ⤷ Subscribe
New Zealand
Patent: 3616
Patent: RADIOPHARMACEUTICAL COMPOSITION
Estimated Expiration: ⤷ Subscribe
Norway
Patent: 15006
Estimated Expiration: ⤷ Subscribe
Poland
Patent: 82988
Estimated Expiration: ⤷ Subscribe
Portugal
Patent: 82988
Estimated Expiration: ⤷ Subscribe
Russian Federation
Patent: 75267
Patent: РАДИОФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ (RADIOPHARMACEUTICAL COMPOSITION)
Estimated Expiration: ⤷ Subscribe
Patent: 10101935
Patent: РАДИОФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ
Estimated Expiration: ⤷ Subscribe
South Africa
Patent: 1000718
Patent: Radiopharmaceutical composition
Estimated Expiration: ⤷ Subscribe
South Korea
Patent: 1571572
Estimated Expiration: ⤷ Subscribe
Patent: 100055440
Patent: RADIOPHARMACEUTICAL COMPOSITION
Estimated Expiration: ⤷ Subscribe
Spain
Patent: 64715
Estimated Expiration: ⤷ Subscribe
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 VIZAMYL around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Hong Kong | 1146710 | RADIOPHARMACEUTICAL COMPOSITION | ⤷ Subscribe |
Portugal | 2182988 | ⤷ Subscribe | |
Russian Federation | 2005131872 | ПРОИЗВОДНЫЕ БЕНЗОТИАЗОЛА (ВАРИАНТЫ), ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ ДЛЯ ДЕТЕКЦИИ ОТЛОЖЕНИЙ АМИЛОИДА И СПОСОБ ИХ ДЕТЕКЦИИ У МЛЕКОПИТАЮЩЕГО | ⤷ Subscribe |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for VIZAMYL
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2182988 | 6/2015 | Austria | ⤷ Subscribe | PRODUCT NAME: (18F) - FLUTEMETAMOL; REGISTRATION NO/DATE: EU/1/14/941 (MITTEILUNG) 20140826 |
2182988 | 2015006 | Norway | ⤷ Subscribe | PRODUCT NAME: VIZAMYL; REG. NO/DATE: EU/1/14/941 20140822 |
1611115 | C20150004 00139 | Estonia | ⤷ Subscribe | PRODUCT NAME: FLUTEMETAMOOL (18F);REG NO/DATE: EU/1/14/941 26.08.2014 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
VIZAMYL Market Analysis and Financial Projection Experimental
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