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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, Sun Pharm, Teva Pharms Usa, Torrent, and Zydus Pharms, and is included in ten 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 six tentative approvals for this compound.
Summary for lurasidone hydrochloride
| International Patents: | 66 |
| US Patents: | 9 |
| Tradenames: | 2 |
| Applicants: | 10 |
| NDAs: | 10 |
| Drug Master File Entries: | 26 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 37 |
| Clinical Trials: | 69 |
| Patent Applications: | 14 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for lurasidone hydrochloride |
| DailyMed Link: | lurasidone hydrochloride at DailyMed |
Recent Clinical Trials for lurasidone hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Sumitomo Pharmaceutical (Suzhou) Co., Ltd. | Phase 3 |
| New York State Psychiatric Institute | Phase 4 |
| Columbia University | Phase 4 |
Generic filers with tentative approvals for LURASIDONE HYDROCHLORIDE
| Applicant | Application No. | Strength | Dosage Form |
| Start Trial | Start Trial | 80MG | TABLET;ORAL |
| Start Trial | Start Trial | 60MG | TABLET;ORAL |
| Start Trial | Start Trial | 40MG | 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
| 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 | 200603-003 | Dec 7, 2011 | AB | RX | Yes | No | Start Trial | Start Trial | Start Trial | |||
| Sunovion Pharms Inc | LATUDA | lurasidone hydrochloride | TABLET;ORAL | 200603-004 | Apr 26, 2012 | AB | RX | Yes | No | Start Trial | Start Trial | Start Trial | |||
| Sunovion Pharms Inc | LATUDA | lurasidone hydrochloride | TABLET;ORAL | 200603-003 | Dec 7, 2011 | AB | RX | Yes | No | Start Trial | Start Trial | Start Trial | |||
| Teva Pharms Usa | LURASIDONE HYDROCHLORIDE | lurasidone hydrochloride | TABLET;ORAL | 208060-004 | May 17, 2019 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Amneal Pharms Co | LURASIDONE HYDROCHLORIDE | lurasidone hydrochloride | TABLET;ORAL | 208002-003 | Jan 3, 2019 | DISCN | No | No | Start Trial | Start Trial | Start 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 | 200603-002 | 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 | 200603-001 | Oct 28, 2010 | 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 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for lurasidone hydrochloride
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Denmark | 1884242 | Start Trial |
| China | 1832946 | Start Trial |
| South Korea | 101085806 | Start Trial |
| Japan | 5855670 | Start Trial |
| Japan | 6470164 | 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 | 251 5024-2014 | Slovakia | Start Trial | PRODUCT NAME: LURASIDON; REGISTRATION NO/DATE: EU/14/913/001 - EU/14/913/021 20140327 |
| 1884242 | CR 2014 00049 | Denmark | Start Trial | PRODUCT NAME: LURASIDON HYDROCHLORID; REG. NO/DATE: EU/1/14/913/001-021 20140327 |
| 1884242 | C01884242/01 | Switzerland | Start Trial | PRODUCT NAME: LURASIDON; REGISTRATION NO/DATE: SWISSMEDIC 62785 12.08.2013 |
| 1884242 | 1490057-5 | Sweden | Start Trial | PRODUCT NAME: LURASIDONE, OPTIONALLY IN THE FORM OF LURASIDONE HYDROCHLORIDE; REG. NO/DATE: EU/1/14/913 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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