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, Alembic, Alkem Labs Ltd, Amneal Pharms Co, Annora Pharma, Aurobindo Pharma Ltd, Avet Lifesciences, Dr Reddys, Invagen Pharms, Lupin Ltd, Macleods Pharms Ltd, MSN, Slate Run Pharma, Sun Pharm, Teva Pharms Usa, Torrent, Watson Labs Teva, and Zydus Pharms, and is included in nineteen 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-nine patent family members in twenty-four countries.
There are twenty-six drug master file entries for lurasidone hydrochloride. Twenty-eight suppliers are listed for this compound. There are two tentative approvals for this compound.
Summary for lurasidone hydrochloride
International Patents: | 69 |
US Patents: | 9 |
Tradenames: | 2 |
Applicants: | 19 |
NDAs: | 19 |
Drug Master File Entries: | 26 |
Finished Product Suppliers / Packagers: | 28 |
Raw Ingredient (Bulk) Api Vendors: | 47 |
Clinical Trials: | 79 |
Patent Applications: | 121 |
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 |
Statistics Collaborative, Inc. | Phase 2/Phase 3 |
Generic filers with tentative approvals for LURASIDONE HYDROCHLORIDE
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 120MG | TABLET;ORAL |
⤷ Sign Up | ⤷ Sign Up | 80MG | TABLET;ORAL |
⤷ Sign Up | ⤷ Sign Up | 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
Anatomical Therapeutic Chemical (ATC) Classes 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Teva Pharms Usa | LURASIDONE HYDROCHLORIDE | lurasidone hydrochloride | TABLET;ORAL | 208060-004 | May 17, 2019 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Sunovion Pharms Inc | LATUDA | lurasidone hydrochloride | TABLET;ORAL | 200603-003 | Dec 7, 2011 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
Annora Pharma | LURASIDONE HYDROCHLORIDE | lurasidone hydrochloride | TABLET;ORAL | 218174-001 | Aug 21, 2024 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Torrent | LURASIDONE HYDROCHLORIDE | lurasidone hydrochloride | TABLET;ORAL | 208055-003 | Jan 3, 2019 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Sunovion Pharms Inc | LATUDA | lurasidone hydrochloride | TABLET;ORAL | 200603-002 | Oct 28, 2010 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
>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 | 200603-005 | Jul 12, 2013 | ⤷ Sign Up | ⤷ Sign Up |
Sunovion Pharms Inc | LATUDA | lurasidone hydrochloride | TABLET;ORAL | 200603-001 | Oct 28, 2010 | ⤷ Sign Up | ⤷ Sign Up |
Sunovion Pharms Inc | LATUDA | lurasidone hydrochloride | TABLET;ORAL | 200603-003 | Dec 7, 2011 | ⤷ Sign Up | ⤷ Sign Up |
Sunovion Pharms Inc | LATUDA | lurasidone hydrochloride | TABLET;ORAL | 200603-002 | Oct 28, 2010 | ⤷ Sign Up | ⤷ Sign Up |
Sunovion Pharms Inc | LATUDA | lurasidone hydrochloride | TABLET;ORAL | 200603-004 | Apr 26, 2012 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for lurasidone hydrochloride
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
World Intellectual Property Organization (WIPO) | 2012063513 | ⤷ Sign Up | |
Netherlands | 300690 | ⤷ Sign Up | |
Japan | 6470164 | ⤷ Sign Up | |
Mexico | 2007014872 | COMPOSICION FARMACEUTICA. (PHARMACEUTICAL COMPOSITION.) | ⤷ Sign Up |
Poland | 1884242 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for lurasidone hydrochloride
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1884242 | C01884242/01 | Switzerland | ⤷ Sign Up | FORMER OWNER: SUMITOMO DAINIPPON PHARMA CO., LTD., JP |
1884242 | PA2014034,C1884242 | Lithuania | ⤷ Sign Up | PRODUCT NAME: LURASIDONUM; REGISTRATION NO/DATE: EU/1/14/913 20140321 |
1884242 | 1490057-5 | Sweden | ⤷ Sign Up | PRODUCT NAME: LURASIDONE, OPTIONALLY IN THE FORM OF LURASIDONE HYDROCHLORIDE; REG. NO/DATE: EU/1/14/913 20140327 |
1884242 | 56/2014 | Austria | ⤷ Sign Up | PRODUCT NAME: LURASIDON, GEGEBENENFALLS IN FORM SEINER FREIEN BASE ODER PHARMAZEUTISCH ANNEHMBARE SALZE DAVON.; REGISTRATION NO/DATE: EU/1/14/913 20140327 |
1884242 | C300690 | Netherlands | ⤷ Sign Up | PRODUCT NAME: LURASIDON, OPTIONEEL IN DE VORM VAN ZIJN VRIJE BASE OF FARMACEUTISCH ACCEPTABELE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/14/913 20140321 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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