latuda Drug Patent Profile
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When do Latuda patents expire, and when can generic versions of Latuda launch?
Latuda is a drug marketed by Sunovion Pharms Inc and is included in one NDA. There are nine patents protecting this drug and one Paragraph IV challenge.
This drug has sixty-nine patent family members in twenty-four countries.
The generic ingredient in LATUDA is lurasidone hydrochloride. There are twenty-six drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the lurasidone hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Latuda
A generic version of latuda was approved as lurasidone hydrochloride by ACCORD HLTHCARE on January 3rd, 2019.
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Summary for latuda
International Patents: | 69 |
US Patents: | 9 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 104 |
Clinical Trials: | 24 |
Patent Applications: | 55 |
Drug Prices: | Drug price information for latuda |
Drug Sales Revenues: | Drug sales revenues for latuda |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for latuda |
What excipients (inactive ingredients) are in latuda? | latuda excipients list |
DailyMed Link: | latuda at DailyMed |
Recent Clinical Trials for latuda
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
New York State Psychiatric Institute | Phase 4 |
Columbia University | Phase 4 |
Astellas Pharma Global Development, Inc. | Phase 2 |
Pharmacology for latuda
Drug Class | Atypical Antipsychotic |
Paragraph IV (Patent) Challenges for LATUDA
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
LATUDA | Tablets | lurasidone hydrochloride | 20 mg, 40 mg, 60 mg, 80 mg, and 120 mg | 200603 | 14 | 2014-10-28 |
US Patents and Regulatory Information for latuda
latuda is protected by eleven US patents.
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sunovion Pharms Inc | LATUDA | lurasidone hydrochloride | TABLET;ORAL | 200603-002 | Oct 28, 2010 | AB | RX | Yes | No | ⤷ Subscribe | ⤷ Subscribe | Y | ⤷ Subscribe | ||
Sunovion Pharms Inc | LATUDA | lurasidone hydrochloride | TABLET;ORAL | 200603-005 | Jul 12, 2013 | AB | RX | Yes | No | ⤷ Subscribe | ⤷ Subscribe | Y | ⤷ Subscribe | ||
Sunovion Pharms Inc | LATUDA | lurasidone hydrochloride | TABLET;ORAL | 200603-004 | Apr 26, 2012 | AB | RX | Yes | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ 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 latuda
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Sunovion Pharms Inc | LATUDA | lurasidone hydrochloride | TABLET;ORAL | 200603-001 | Oct 28, 2010 | ⤷ Subscribe | ⤷ Subscribe |
Sunovion Pharms Inc | LATUDA | lurasidone hydrochloride | TABLET;ORAL | 200603-002 | Oct 28, 2010 | ⤷ Subscribe | ⤷ Subscribe |
Sunovion Pharms Inc | LATUDA | lurasidone hydrochloride | TABLET;ORAL | 200603-002 | Oct 28, 2010 | ⤷ Subscribe | ⤷ Subscribe |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for latuda
When does loss-of-exclusivity occur for latuda?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Australia
Patent: 06250340
Patent: Pharmaceutical composition
Estimated Expiration: ⤷ Subscribe
Brazil
Patent: 0611409
Patent: preparação oral e método de granulação de uma mistura em pó
Estimated Expiration: ⤷ Subscribe
Patent: 2020005056
Estimated Expiration: ⤷ Subscribe
Canada
Patent: 06510
Patent: COMPOSITION PHARMACEUTIQUE (PHARMACEUTICAL COMPOSITION)
Estimated Expiration: ⤷ Subscribe
China
Patent: 1184489
Patent: Pharmaceutical composition
Estimated Expiration: ⤷ Subscribe
Patent: 2048734
Patent: Pharmaceutical composition
Estimated Expiration: ⤷ Subscribe
Cyprus
Patent: 14118
Estimated Expiration: ⤷ Subscribe
Patent: 14039
Estimated Expiration: ⤷ Subscribe
Denmark
Patent: 84242
Estimated Expiration: ⤷ Subscribe
Patent: 22783
Estimated Expiration: ⤷ Subscribe
European Patent Office
Patent: 84242
Patent: COMPOSITION PHARMACEUTIQUE COMPRENANT LE LURASIDONE (PHARMACEUTICAL COMPOSITION COMPRISING LURASIDONE)
Estimated Expiration: ⤷ Subscribe
Patent: 22783
Patent: Composition pharmaceutique (Pharmaceutical Composition)
Estimated Expiration: ⤷ Subscribe
France
Patent: C0069
Estimated Expiration: ⤷ Subscribe
Hong Kong
Patent: 08379
Patent: PHARMACEUTICAL COMPOSITION COMPRISING LURASIDONE
Estimated Expiration: ⤷ Subscribe
Hungary
Patent: 400051
Estimated Expiration: ⤷ Subscribe
Japan
Patent: 2006126681
Patent: 医薬品組成物
Estimated Expiration: ⤷ Subscribe
Patent: 33120
Estimated Expiration: ⤷ Subscribe
Patent: 85105
Estimated Expiration: ⤷ Subscribe
Patent: 11126915
Patent: PHARMACEUTICAL COMPOSITION
Estimated Expiration: ⤷ Subscribe
Luxembourg
Patent: 550
Estimated Expiration: ⤷ Subscribe
Mexico
Patent: 07014872
Patent: COMPOSICION FARMACEUTICA. (PHARMACEUTICAL COMPOSITION.)
Estimated Expiration: ⤷ Subscribe
Netherlands
Patent: 0690
Estimated Expiration: ⤷ Subscribe
Poland
Patent: 84242
Estimated Expiration: ⤷ Subscribe
Portugal
Patent: 84242
Estimated Expiration: ⤷ Subscribe
Russian Federation
Patent: 98586
Patent: ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ (PHARMACEUTICAL COMPOSITIONS)
Estimated Expiration: ⤷ Subscribe
Patent: 07148997
Patent: ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ
Estimated Expiration: ⤷ Subscribe
Slovenia
Patent: 84242
Estimated Expiration: ⤷ Subscribe
South Korea
Patent: 1380088
Estimated Expiration: ⤷ Subscribe
Patent: 1552033
Estimated Expiration: ⤷ Subscribe
Patent: 080012306
Patent: PHARMACEUTICAL COMPOSITION
Estimated Expiration: ⤷ Subscribe
Patent: 130122019
Patent: PHARMACEUTICAL COMPOSITION
Estimated Expiration: ⤷ Subscribe
Spain
Patent: 08687
Estimated Expiration: ⤷ Subscribe
Patent: 35478
Estimated Expiration: ⤷ Subscribe
Taiwan
Patent: 59020
Estimated Expiration: ⤷ Subscribe
Patent: 0800197
Patent: Pharmaceutical composition
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 latuda around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | 2013541582 | ⤷ Subscribe | |
Japan | 4610485 | ⤷ Subscribe | |
Japan | 2800953 | ⤷ Subscribe | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for latuda
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1884242 | 1490057-5 | Sweden | ⤷ Subscribe | PRODUCT NAME: LURASIDONE, OPTIONALLY IN THE FORM OF LURASIDONE HYDROCHLORIDE; REG. NO/DATE: EU/1/14/913 20140327 |
1884242 | 122014000092 | Germany | ⤷ Subscribe | PRODUCT NAME: LURASIDON, INSBESONDERE EINE PHARMAZEUTISCH VERTRAEGLICHE SALZFORM UND IM SPEZIELLEN DAS HYDROCHLORIDSALZ DAVON; REGISTRATION NO/DATE: EU/1/14/913/001-021 20140321 |
1884242 | SPC/GB14/063 | United Kingdom | ⤷ Subscribe | PRODUCT NAME: LURASIDONE HYDROCHLORIDE; REGISTERED: UK EU/1/14/913/001 20140327; UK EU/1/14/913/002 20140327; UK EU/1/14/913/003 20140327; UK EU/1/14/913/004 20140327; UK EU/1/14/913/005 20140327; UK EU/1/14/913/006 20140327; UK EU/1/14/913/007 20140327; UK EU/1/14/913/008 20140327; UK EU/1/14/913/009 20140327; UK EU/1/14/913/010 20140327; UK EU/1/14/913/011 20140327; UK EU/1/14/913/012 20140327; UK EU/1/14/913/013 20140327; UK EU/1/14/913/014 20140327; UK EU/1/14/913/015 20140327; UK EU/1/14/913/016 20140327; UK EU/1/14/913/017 20140327; UK EU/1/14/913/018 20140327; UK EU/1/14/913/019 20140327; UK EU/1/14/913/020 20140327; UK EU/1/14/913/021 20140327 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Latuda Market Analysis and Financial Projection Experimental
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