Lurasidone hydrochloride - Generic Drug Details
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What are the generic drug 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, Alembic, Alkem Labs Ltd, Amneal Pharms Co, Aurobindo Pharma Ltd, Avet Lifesciences, Dr Reddys, Invagen Pharms, Lupin Ltd, Macleods Pharms Ltd, MSN, Piramal Hlthcare Uk, Sun Pharm, Teva Pharms Usa, Torrent, Watson Labs Teva, and Zydus Pharms, and is included in eighteen 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-eight patent family members in twenty-four countries.
There are twenty-six drug master file entries for lurasidone hydrochloride. Twenty-four suppliers are listed for this compound. There are two tentative approvals for this compound.
Summary for lurasidone hydrochloride
International Patents: | 68 |
US Patents: | 9 |
Tradenames: | 2 |
Applicants: | 18 |
NDAs: | 18 |
Drug Master File Entries: | 26 |
Finished Product Suppliers / Packagers: | 24 |
Raw Ingredient (Bulk) Api Vendors: | 47 |
Clinical Trials: | 79 |
Patent Applications: | 137 |
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 |
---|---|
First Affiliated Hospital of Zhejiang University | Phase 4 |
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico | Phase 4 |
NeuroRx, Inc. | Phase 2/Phase 3 |
Generic filers with tentative approvals for LURASIDONE HYDROCHLORIDE
Applicant | Application No. | Strength | Dosage Form |
⤷ Try a Trial | ⤷ Try a Trial | 120MG | TABLET;ORAL |
⤷ Try a Trial | ⤷ Try a Trial | 80MG | TABLET;ORAL |
⤷ Try a Trial | ⤷ Try a Trial | 60MG | 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 | 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 lurasidone hydrochloride
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Lupin Ltd | LURASIDONE HYDROCHLORIDE | lurasidone hydrochloride | TABLET;ORAL | 208031-001 | Jan 3, 2019 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ 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 | ||
Avet Lifesciences | LURASIDONE HYDROCHLORIDE | lurasidone hydrochloride | TABLET;ORAL | 208058-002 | Sep 4, 2019 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Invagen Pharms | LURASIDONE HYDROCHLORIDE | lurasidone hydrochloride | TABLET;ORAL | 208028-005 | Jan 3, 2019 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ 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 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 | ⤷ Try a Trial | ⤷ Try a Trial |
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 | 200603-004 | Apr 26, 2012 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for lurasidone hydrochloride
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Hungary | S1400051 | ⤷ Try a Trial | |
Spain | 2535478 | ⤷ Try a Trial | |
Canada | 2814828 | PROCEDE DE TRAITEMENT DE TROUBLES MENTAUX (METHOD OF TREATMENT FOR MENTAL DISORDERS) | ⤷ Try a Trial |
South Korea | 101085806 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for lurasidone hydrochloride
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
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 | CA 2014 00049 | Denmark | ⤷ Try a Trial | PRODUCT NAME: LURASIDON, EVENTUELT I FORM AF DEN FRIE BASE ELLER FARMACEUTISK ACCEPTABLE SALTE DERAF, HERUNDER LURASIDONHYDROCHLORID; REG. NO/DATE: EU/1/14/913/001-021 20140321 |
1884242 | C300690 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: LURASIDON, OPTIONEEL IN DE VORM VAN ZIJN VRIJE BASE OF FARMACEUTISCH ACCEPTABELE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/14/913 20140321 |
1884242 | C20140030 00118 | Estonia | ⤷ Try a Trial | PRODUCT NAME: LURASIDOON;REG NO/DATE: K(2014)2046 (LOPLIK) 27.03.2014 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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