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Lurasidone hydrochloride - Generic Drug Details
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What are the generic drug sources for lurasidone hydrochloride and what is the scope of freedom to operate?
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 ten patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Lurasidone hydrochloride has seventy-six patent family members in twenty-four 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: | 76 |
| US Patents: | 10 |
| Tradenames: | 2 |
| Applicants: | 10 |
| NDAs: | 10 |
| Drug Master File Entries: | 26 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 36 |
| Clinical Trials: | 68 |
| Patent Applications: | 13 |
| 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 |
|---|---|
| New York State Psychiatric Institute | Phase 4 |
| Columbia University | Phase 4 |
| Massachusetts General Hospital | Early Phase 1 |
Recent Litigation for lurasidone hydrochloride
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| PIRAMAL HEALTHCARE UK LIMITED v. SUMITOMO DAINIPPON PHARMA CO., LTD. | 2019-06-26 |
| SUMITOMO DAINIPPON PHARMA CO., LTD. v. ALKEM LABORATORIES LIMITED | 2018-10-09 |
| SUMITOMO DAINIPPON PHARMA CO., LTD. v. MACLEODS PHARMACEUTICALS LTD. | 2018-09-12 |
See all lurasidone hydrochloride litigation
PTAB Litigation
| Petitioner | Date |
|---|---|
| Par Pharmaceutical, Inc. | 2017-04-18 |
Generic filers with tentative approvals for LURASIDONE HYDROCHLORIDE
| Applicant | Application No. | Strength | Dosage Form |
| Start Trial | Start Trial | 120MG | TABLET;ORAL |
| Start Trial | Start Trial | 80MG | TABLET;ORAL |
| Start Trial | Start 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
Synonyms for lurasidone hydrochloride
| (3aR,4S,7R,7aS)-2-(((1R,2R)-2-((4-(benzo[d]isothiazol-3-yl)piperazin-1-yl)methyl)cyclohexyl)methyl)hexahydro-1H-4,7-methanoisoindole-1,3(2H)-dione hydrochloride |
| (3aR,4S,7R,7aS)-2-[(1R,2R)-2-[4-(1,2-Benzisothiazol-3-yl)piperazin-1-ylmethyl]cyclohexylmethyl]hexahydro-1H-4,7-methanoisoindole-1,3-dione hydrochloride |
| (3aR,4S,7R,7aS)-2-{(1R,2R)-2-[4-(1,2-benzisothiazol-3-yl)piperazin-1-ylmethyl]cyclohexylmethyl}hexahydro-4,7-methano-2H-isoindole-1,3-dione hydrochloride |
| (3aR,4S,7R,7aS)-2-{[(1R,2R)-2-{[4-(1,2-benzothiazol-3-yl)piperazin-1-yl]methyl}cyclohexyl]methyl}hexahydro-1H-4,7-methanoisoindole-1,3(2H)-dione hydrochloride |
| 1132654-54-6 |
| 2525AH |
| 367514-88-3 |
| 4-(1,2-benzothiazol-3-yl)-1-{[(1R,2R)-2-{[(3aR,4S,7R,7aS)-1,3-dioxooctahydro-2H-4,7-methanoisoindol-2-yl]methyl}cyclohexyl]methyl}piperazin-1-ium chloride |
| 4,7-Methano-1H-isoindole-1,3(2H)-dione, 2-(((1R,2R)-2-((4-(1,2-benzisothiazol-3-yl)-1-piperazinyl)methyl)cyclohexyl)methyl)hexahydro-, monohydrochloride, (3aR,4S,7R,7aS)- |
| 441351-20-8 |
| AK142737 |
| AKOS022185856 |
| AS-35074 |
| C28H36N4O2S.ClH |
| CHEBI:70732 |
| CHEMBL1615372 |
| D04820 |
| EX-3125 |
| Latuda |
| Latuda (TN) |
| Lurasidone HCl |
| Lurasidone hydrochloride (JAN/USAN) |
| Lurasidone hydrochloride [USAN] |
| Lurasidone hydrochloride solution, 1.0 mg/mL in methanol (as free base), ampule of 1 mL, certified reference material |
| Lurasidone hydrochloride, >=98% (HPLC) |
| lurasidone monohydrochloride |
| Lurasidone-d8 Hydrochloride |
| Lurasidonhydrochloride |
| MK-3756 |
| MolPort-035-395-724 |
| NEKCRUIRPWNMLK-SCIYSFAVSA-N |
| O0P4I5851I |
| s3044 |
| SB16829 |
| SCHEMBL1534132 |
| SM 13496 |
| SM-13496 |
| SMP-13496 |
| UNII-O0P4I5851I |
| W-5801 |
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 | 200603-001 | Oct 28, 2010 | AB | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
| Sunovion Pharms Inc | LATUDA | lurasidone hydrochloride | TABLET;ORAL | 200603-005 | Jul 12, 2013 | AB | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | ||
| Sunovion Pharms Inc | LATUDA | lurasidone hydrochloride | TABLET;ORAL | 200603-004 | Apr 26, 2012 | AB | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | ||
| Sunovion Pharms Inc | LATUDA | lurasidone hydrochloride | TABLET;ORAL | 200603-004 | Apr 26, 2012 | AB | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | ||
| Sunovion Pharms Inc | LATUDA | lurasidone hydrochloride | TABLET;ORAL | 200603-004 | Apr 26, 2012 | AB | RX | Yes | No | Start Trial | Start Trial | Y | 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 | 200603-005 | Jul 12, 2013 | 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 | 200603-001 | Oct 28, 2010 | 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 |
|---|---|---|
| Japan | WO2005009999 | Start Trial |
| Luxembourg | 92550 | Start Trial |
| Russian Federation | 2398586 | Start Trial |
| South Korea | 20130122019 | Start Trial |
| Japan | 4610485 | 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 | PA2014034 | Lithuania | Start Trial | PRODUCT NAME: LURASIDONUM; REGISTRATION NO/DATE: EU/1/14/913 20140321 |
| 1884242 | C300690 | Netherlands | Start 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 | 1490057-5 | Sweden | Start Trial | PRODUCT NAME: LURASIDONE, OPTIONALLY IN THE FORM OF LURASIDONE HYDROCHLORIDE; REG. NO/DATE: EU/1/14/913 20140327 |
| 1884242 | 14C0069 | France | Start 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 | Start Trial | PRODUCT NAME: LURASIDON HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/14/913 20140327 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Site Map
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Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2020, www.DrugPatentWatch.com.