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Lurasidone hydrochloride - Generic Drug Details
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What are the generic sources for lurasidone hydrochloride and what is the scope of patent protection?
Lurasidone hydrochloride
is the generic ingredient in two branded drugs marketed by Sunovion Pharms Inc, Accord Hlthcare, Amneal Pharms Co, Emcure Pharms Ltd, Invagen Pharms, Lupin Ltd, Piramal Hlthcare Uk, Sun Pharm, Teva Pharms Usa, Torrent, and Zydus Pharms, and is included in eleven NDAs. There are nine patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Lurasidone hydrochloride has sixty-six patent family members in twenty-three countries.
There are twenty-six drug master file entries for lurasidone hydrochloride. Two suppliers are listed for this compound. There are five tentative approvals for this compound.
Summary for lurasidone hydrochloride
International Patents: | 66 |
US Patents: | 9 |
Tradenames: | 2 |
Applicants: | 11 |
NDAs: | 11 |
Drug Master File Entries: | 26 |
Suppliers / Packagers: | 2 |
Bulk Api Vendors: | 39 |
Clinical Trials: | 70 |
Patent Applications: | 14 |
Formulation / Manufacturing: | see details |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for lurasidone hydrochloride |
What excipients (inactive ingredients) are in lurasidone hydrochloride? | lurasidone hydrochloride excipients list |
DailyMed Link: | lurasidone hydrochloride at DailyMed |
Recent Clinical Trials for lurasidone hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Jayasree Basivireddy | Phase 3 |
Sumitomo Pharmaceutical (Suzhou) Co., Ltd. | Phase 3 |
New York State Psychiatric Institute | Phase 4 |
Generic filers with tentative approvals for LURASIDONE HYDROCHLORIDE
Applicant | Application No. | Strength | Dosage Form |
Start Trial | Start Trial | 20MG | TABLET;ORAL |
Start Trial | Start Trial | 120MG | TABLET;ORAL |
Start Trial | Start Trial | 80MG | TABLET;ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for lurasidone hydrochloride
Drug Class | Atypical Antipsychotic |
Medical Subject Heading (MeSH) Categories for lurasidone hydrochloride
Paragraph IV (Patent) Challenges for LURASIDONE HYDROCHLORIDE
Tradename | Dosage | Ingredient | NDA | Submissiondate |
---|---|---|---|---|
LATUDA | TABLET;ORAL | lurasidone hydrochloride | 200603 | 2014-10-28 |
US Patents and Regulatory Information for lurasidone hydrochloride
Expired US Patents for lurasidone hydrochloride
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 | Start Trial | Start Trial |
Sunovion Pharms Inc | LATUDA | lurasidone hydrochloride | TABLET;ORAL | 200603-003 | Dec 7, 2011 | Start Trial | Start Trial |
Sunovion Pharms Inc | LATUDA | lurasidone hydrochloride | TABLET;ORAL | 200603-004 | Apr 26, 2012 | Start Trial | Start Trial |
Sunovion Pharms Inc | LATUDA | lurasidone hydrochloride | TABLET;ORAL | 200603-005 | Jul 12, 2013 | Start Trial | Start Trial |
Sunovion Pharms Inc | LATUDA | lurasidone hydrochloride | TABLET;ORAL | 200603-002 | Oct 28, 2010 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for lurasidone hydrochloride
Country | Patent Number | Estimated Expiration |
---|---|---|
Denmark | 1652848 | Start Trial |
Spain | 2326078 | Start Trial |
Hungary | S1400051 | Start Trial |
European Patent Office | 1944030 | Start Trial |
Taiwan | I359020 | Start Trial |
Netherlands | 300690 | Start Trial |
Australia | 2004259305 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for lurasidone hydrochloride
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1884242 | 551 | Finland | Start Trial | |
1884242 | 251 5024-2014 | Slovakia | Start Trial | PRODUCT NAME: LURASIDON; REGISTRATION NO/DATE: EU/14/913/001 - EU/14/913/021 20140327 |
1884242 | 92550 | Luxembourg | Start Trial | PRODUCT NAME: LURASIDONE, FACULTATIVEMENT SOUS FORME DE SA BASE LIBRE OU DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES. FIRST REGISTRATION: 20140327 |
1884242 | C01884242/01 | Switzerland | Start Trial | PRODUCT NAME: LURASIDON; REGISTRATION NO/DATE: SWISSMEDIC 62785 12.08.2013 |
1884242 | 122014000092 | Germany | Start Trial | 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 | C 2014 038 | Romania | Start Trial | PRODUCT NAME: LURASIDONA, OPTIONAL SUB FORMA BAZEI EI LIBERE SAU CA SARURIACCEPTABILE FARMACEUTIC ALE ACESTEIA, IN SPECIAL CLORHIDRAT DE LURASIDONA -C28H36N4O2S; NATIONAL AUTHORISATION NUMBER: EU/1/14/913; DATE OF NATIONAL AUTHORISATION: 20140321; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/913; DATE OF FIRST AUTHORISATION IN EEA: 20140321 |
1884242 | 1490057-5 | Sweden | Start Trial | PRODUCT NAME: LURASIDONE, OPTIONALLY IN THE FORM OF LURASIDONE HYDROCHLORIDE; REG. NO/DATE: EU/1/14/913 20140327 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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