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Hoffmann La Roche Company Profile
What is the competitive landscape for HOFFMANN LA ROCHE, and when can generic versions of HOFFMANN LA ROCHE drugs launch?
HOFFMANN LA ROCHE has thirteen approved drugs.
There are thirteen US patents protecting HOFFMANN LA ROCHE drugs.
There are three hundred and forty-eight patent family members on HOFFMANN LA ROCHE drugs in fifty-two countries and twenty-eight supplementary protection certificates in fifteen countries.
Summary for Hoffmann La Roche
| International Patents: | 348 |
| US Patents: | 13 |
| Tradenames: | 11 |
| Ingredients: | 10 |
| NDAs: | 13 |
Drugs and US Patents for Hoffmann La Roche
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hoffmann La Roche | ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINER | ceftriaxone sodium | INJECTABLE;INJECTION | 050624-003 | Feb 11, 1987 | DISCN | Yes | No | Start Trial | Start Trial | |||||
| Hoffmann La Roche | INVIRASE | saquinavir mesylate | CAPSULE;ORAL | 020628-001 | Dec 6, 1995 | DISCN | Yes | No | Start Trial | Start Trial | |||||
| Hoffmann La Roche | BONIVA | ibandronate sodium | TABLET;ORAL | 021455-002 | Mar 24, 2005 | AB | RX | Yes | Yes | 7,410,957 | Start Trial | Start Trial | |||
| Hoffmann La Roche | ZELBORAF | vemurafenib | TABLET;ORAL | 202429-001 | Aug 17, 2011 | RX | Yes | Yes | 8,470,818 | Start Trial | Start Trial | ||||
| Hoffmann La Roche | ZELBORAF | vemurafenib | TABLET;ORAL | 202429-001 | Aug 17, 2011 | RX | Yes | Yes | 7,504,509 | Start Trial | Y | Y | Start Trial | ||
| Hoffmann La Roche | ZELBORAF | vemurafenib | TABLET;ORAL | 202429-001 | Aug 17, 2011 | RX | Yes | Yes | 8,741,920 | Start Trial | Y | 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 Hoffmann La Roche
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Hoffmann La Roche | VALCYTE | valganciclovir hydrochloride | FOR SOLUTION;ORAL | 022257-001 | Aug 28, 2009 | 6,083,953*PED | Start Trial |
| Hoffmann La Roche | ACCUTANE | isotretinoin | CAPSULE;ORAL | 018662-004 | Mar 28, 1983 | 4,322,438 | Start Trial |
| Hoffmann La Roche | XELODA | capecitabine | TABLET;ORAL | 020896-001 | Apr 30, 1998 | 4,966,891 | Start Trial |
| Hoffmann La Roche | BONIVA | ibandronate sodium | TABLET;ORAL | 021455-002 | Mar 24, 2005 | 6,294,196 | Start Trial |
| Hoffmann La Roche | ACCUTANE | isotretinoin | CAPSULE;ORAL | 018662-002 | May 7, 1982 | 4,200,647 | Start Trial |
| Hoffmann La Roche | XELODA | capecitabine | TABLET;ORAL | 020896-002 | Apr 30, 1998 | 5,472,949*PED | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Paragraph IV (Patent) Challenges for HOFFMANN LA ROCHE drugs
| Drugname | Dosage | Strength | Tradename | Submissiondate |
|---|---|---|---|---|
| ➤ Subscribe | Tablets | 450 mg | ➤ Subscribe | 2005-12-27 |
| ➤ Subscribe | Injection | 1 mg/mL, 3 mL Vial | ➤ Subscribe | 2007-08-31 |
| ➤ Subscribe | Tablets | 150 mg and 500 mg | ➤ Subscribe | 2008-11-10 |
| ➤ Subscribe | For Oral Solution | 50 mg/mL | ➤ Subscribe | 2011-03-21 |
| ➤ Subscribe | Tablets | 2.5 mg and 150 mg | ➤ Subscribe | 2007-05-16 |
Premature patent expirations for HOFFMANN LA ROCHE
Expiration due to failure to pay maintenance fee
| Patent Number | Expiration Date |
|---|---|
| Start Trial | Start Trial |
International Patents for Hoffmann La Roche Drugs
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Australia | 2015238857 | Start Trial |
| Ecuador | SP045335 | Start Trial |
| South Korea | 101125919 | Start Trial |
| European Patent Office | 2308563 | Start Trial |
| European Patent Office | 1117412 | Start Trial |
| Israel | 143119 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for Hoffmann La Roche Drugs
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0694547 | SPC/GB02/027 | United Kingdom | Start Trial | PRODUCT NAME: 2-(2-AMINO-1,6-DIHYDRO-6-OXO-PURIN-9-YL)-METHOXY-3-HYDROXY-1-PROPANYL-L-VALINATE HYDROCHLORIDE (VALGANCICLOVIR HYDROCHLORIDE); REGISTERED: NL RVG 25992 20010920; UK PL 00031/0599 20020425 |
| 0316704 | 2001C/021 | Belgium | Start Trial | PRODUCT NAME: CAPECITABINE, NATL REGISTRATION NO/DATE: EU/1/00/163/001 20010205; FIRST REGISTRATION: CH 54657 19980610 |
| 0316704 | SPC/GB01/015 | United Kingdom | Start Trial | PRODUCT NAME: CAPECITABINE AND HYDRATES AND SOLVATES THEREOF; REGISTERED: CH 54657 19980610; UK EU/1/00/163/001-002 20010202 |
| 1893612 | 2012C/028 | Belgium | Start Trial | PRODUCT NAME: VERMURAFENIB ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, SOUS TOUTES FORMES COUVERTES PAR LE BREVET DE BASE; AUTHORISATION NUMBER AND DATE: EU/1/12/751/001 20120221 |
| 1893612 | C20120016 00059 | Estonia | Start Trial | PRODUCT NAME: ZELBORAF - VEMURAFENIIB;REG NO/DATE: C(2012)1180 FINAL 17.02.2012 |
| 1893612 | 28/2012 | Austria | Start Trial | PRODUCT NAME: VEMURAFENIB UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; REGISTRATION NO/DATE: EU/1/12/751/001 (MITTEILUNG) 20120221 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.
Here is a list of applicants with similar names.
