LATUDA Drug Patent Profile
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Which patents cover Latuda, and what generic alternatives are available?
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-five 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.
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: | 64 |
Formulation / Manufacturing: | see details |
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 |
---|---|
Columbia University | Phase 4 |
New York State Psychiatric Institute | Phase 4 |
Astellas Pharma Global Development, Inc. | Phase 2 |
Pharmacology for LATUDA
Drug Class | Atypical Antipsychotic |
Anatomical Therapeutic Chemical (ATC) Classes for LATUDA
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.
Patents protecting LATUDA
Pharmaceutical composition
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Pharmaceutical composition
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Remedy for integration dysfunction syndrome
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Method of treatment for mental disorders
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Pharmaceutical composition
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF SCHIZOPHRENIA
Agent for treatment of schizophrenia
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF MAJOR DEPRESSIVE EPISODES ASSOCIATED WITH BIPOLAR I DISORDER
Agent for treatment of schizophrenia
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF SCHIZOPHRENIA
Method of treatment for mental disorders
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF SCHIZOPHRENIA WITH IMPROVEMENT IN ATTENTION FUNCTION IN SCHIZOPHRENIA
Method of treatment for mental disorders
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF BIPOLAR DEPRESSION WITH IMPROVEMENT IN ATTENTION FUNCTION IN BIPOLAR DISORDER
Pharmaceutical composition
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Process for producing imide compound
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sunovion Pharms Inc | LATUDA | lurasidone hydrochloride | TABLET;ORAL | 200603-002 | Oct 28, 2010 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
Sunovion Pharms Inc | LATUDA | lurasidone hydrochloride | TABLET;ORAL | 200603-005 | Jul 12, 2013 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
Sunovion Pharms Inc | LATUDA | lurasidone hydrochloride | TABLET;ORAL | 200603-004 | Apr 26, 2012 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Sunovion Pharms Inc | LATUDA | lurasidone hydrochloride | TABLET;ORAL | 200603-004 | Apr 26, 2012 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | 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 |
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 | 200603-003 | Dec 7, 2011 | ⤷ Try a Trial | ⤷ Try a Trial |
Sunovion Pharms Inc | LATUDA | lurasidone hydrochloride | TABLET;ORAL | 200603-001 | Oct 28, 2010 | ⤷ Try a Trial | ⤷ Try a Trial |
Sunovion Pharms Inc | LATUDA | lurasidone hydrochloride | TABLET;ORAL | 200603-002 | Oct 28, 2010 | ⤷ Try a Trial | ⤷ Try a Trial |
Sunovion Pharms Inc | LATUDA | lurasidone hydrochloride | TABLET;ORAL | 200603-002 | Oct 28, 2010 | ⤷ Try a Trial | ⤷ Try a Trial |
>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
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 0611409
Estimated Expiration: ⤷ Try a Trial
Patent: 2020005056
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 06510
Estimated Expiration: ⤷ Try a Trial
China
Patent: 1184489
Estimated Expiration: ⤷ Try a Trial
Patent: 2048734
Estimated Expiration: ⤷ Try a Trial
Cyprus
Patent: 14118
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 84242
Estimated Expiration: ⤷ Try a Trial
Patent: 22783
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 84242
Estimated Expiration: ⤷ Try a Trial
Patent: 22783
Estimated Expiration: ⤷ Try a Trial
France
Patent: C0069
Estimated Expiration: ⤷ Try a Trial
Hong Kong
Patent: 08379
Estimated Expiration: ⤷ Try a Trial
Hungary
Patent: 400051
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 2006126681
Estimated Expiration: ⤷ Try a Trial
Patent: 33120
Estimated Expiration: ⤷ Try a Trial
Patent: 85105
Estimated Expiration: ⤷ Try a Trial
Patent: 11126915
Estimated Expiration: ⤷ Try a Trial
Luxembourg
Patent: 550
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 07014872
Estimated Expiration: ⤷ Try a Trial
Netherlands
Patent: 0690
Estimated Expiration: ⤷ Try a Trial
Poland
Patent: 84242
Estimated Expiration: ⤷ Try a Trial
Portugal
Patent: 84242
Estimated Expiration: ⤷ Try a Trial
Russian Federation
Patent: 98586
Estimated Expiration: ⤷ Try a Trial
Patent: 07148997
Estimated Expiration: ⤷ Try a Trial
Slovenia
Patent: 84242
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 1380088
Estimated Expiration: ⤷ Try a Trial
Patent: 1552033
Estimated Expiration: ⤷ Try a Trial
Patent: 080012306
Estimated Expiration: ⤷ Try a Trial
Patent: 130122019
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 08687
Estimated Expiration: ⤷ Try a Trial
Patent: 35478
Estimated Expiration: ⤷ Try a Trial
Taiwan
Patent: 59020
Estimated Expiration: ⤷ Try a Trial
Patent: 0800197
Estimated Expiration: ⤷ Try a 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 LATUDA around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
South Korea | 20060052840 | PROCESS FOR PRODUCING IMIDE COMPOUND | ⤷ Try a Trial |
Denmark | 2422783 | ⤷ Try a Trial | |
Japan | H0517440 | NEW IMIDE DERIVATIVE | ⤷ Try a Trial |
Japan | WO2005009999 | イミド化合物の製造方法 | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for LATUDA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1884242 | 14C0069 | France | ⤷ Try a Trial | PRODUCT NAME: LURASIDONE, EN PARTICULIER SOUS LA FORME DE L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, NOTAMMENT LE CHLORHYDRATE; REGISTRATION NO/DATE: EU/1/14/913 20140327 |
1884242 | 300690 | Netherlands | ⤷ Try a Trial | DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CHANGE OF OWNER(S) NAME |
1884242 | 1490057-5 | Sweden | ⤷ Try a Trial | PRODUCT NAME: LURASIDONE, OPTIONALLY IN THE FORM OF LURASIDONE HYDROCHLORIDE; REG. NO/DATE: EU/1/14/913 20140327 |
1884242 | C01884242/01 | Switzerland | ⤷ Try a Trial | FORMER OWNER: SUMITOMO DAINIPPON PHARMA CO., LTD., JP |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |