.

Pharmaceutical Business Intelligence

  • Anticipate P&T budget requirements
  • Evaluate market entry opportunities
  • Find generic sources and suppliers
  • Predict branded drug patent expiration

► Plans and Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

DrugPatentWatch Database Preview

Lurasidone hydrochloride - Generic Drug Details

« Back to Dashboard
Lurasidone hydrochloride is the generic ingredient in one branded drug marketed by Sunovion Pharms Inc and is included in one NDA. There are six patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

This ingredient has sixty-one patent family members in twenty countries.

There are twenty-two drug master file entries for lurasidone hydrochloride. Two suppliers are listed for this compound. There are six tentative approvals for this compound.

Summary for Generic Name: lurasidone hydrochloride

Tradenames:1
Patents:6
Applicants:1
NDAs:1
Drug Master File Entries: see list22
Suppliers / Packaging: see list2
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: lurasidone hydrochloride

Tentative approvals for LURASIDONE HYDROCHLORIDE

Applicant Application No. Form Dosage
<disabled><disabled>TABLET;ORAL20MG
<disabled><disabled>TABLET;ORAL40MG
<disabled><disabled>TABLET;ORAL60MG
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sunovion Pharms Inc
LATUDA
lurasidone hydrochloride
TABLET;ORAL200603-001Oct 28, 2010RXYes► subscribe► subscribe
Sunovion Pharms Inc
LATUDA
lurasidone hydrochloride
TABLET;ORAL200603-005Jul 12, 2013RXNo8,883,794► subscribeY ► subscribe
Sunovion Pharms Inc
LATUDA
lurasidone hydrochloride
TABLET;ORAL200603-003Dec 7, 2011RXNo► subscribe► subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Non-Orange Book Patents for Generic Ingredient: lurasidone hydrochloride

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
5,780,632 Imide derivatives and their production and use► subscribe
8,258,139Method of treatment for mental disorders► subscribe
7,605,260Process for producing imide compound► subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

Export unavailable in trial.
Subscribe for complete access.

International Patent Family for Ingredient: lurasidone hydrochloride

Country Document Number Estimated Expiration
Australia2006250340► subscribe
China101184489► subscribe
Spain2378990► subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

Export unavailable in trial.
Subscribe for complete access.

Supplementary Protection Certificates for Tradename: LURASIDONE HYDROCHLORIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
/2014Austria► subscribePRODUCT NAME: LURASIDON, GEGEBENENFALLS IN FORM SEINER FREIEN BASE ODER PHARMAZEUTISCH ANNEHMBARE SALZE DAVON.; REGISTRATION NO/DATE: EU/1/14/913 20140327
C0069France► subscribePRODUCT 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
2014034Lithuania► subscribePRODUCT NAME: LURASIDONUM; REGISTRATION NO/DATE: EU/1/14/913 20140321
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

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 verifification 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.

`abc