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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 | ceftriaxone sodium | INJECTABLE;INJECTION | 062654-001 | Apr 30, 1987 | DISCN | No | No | Start Trial | Start Trial | |||||
| Hoffmann La Roche | ACCUTANE | isotretinoin | CAPSULE;ORAL | 018662-003 | May 7, 1982 | DISCN | Yes | No | Start Trial | Start Trial | |||||
| 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 | ZELBORAF | vemurafenib | TABLET;ORAL | 202429-001 | Aug 17, 2011 | RX | Yes | Yes | Start Trial | Start Trial | |||||
| Hoffmann La Roche | ZELBORAF | vemurafenib | TABLET;ORAL | 202429-001 | Aug 17, 2011 | RX | Yes | Yes | Start Trial | Start Trial | |||||
| Hoffmann La Roche | ACCUTANE | isotretinoin | CAPSULE;ORAL | 018662-004 | Mar 28, 1983 | DISCN | Yes | No | Start Trial | Start Trial | |||||
| Hoffmann La Roche | ROCEPHIN | ceftriaxone sodium | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | 050585-001 | Dec 21, 1984 | DISCN | Yes | No | 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 Hoffmann La Roche
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Hoffmann La Roche | VALCYTE | valganciclovir hydrochloride | TABLET;ORAL | 021304-001 | Mar 29, 2001 | 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 | 020896-002 | Apr 30, 1998 | 4,966,891 | Start Trial |
| Hoffmann La Roche | BONIVA | ibandronate sodium | TABLET;ORAL | 021455-001 | May 16, 2003 | 4,927,814 | Start Trial |
| Hoffmann La Roche | INVIRASE | saquinavir mesylate | CAPSULE;ORAL | 020628-001 | Dec 6, 1995 | 5,196,438*PED | Start Trial |
| Hoffmann La Roche | BONIVA | ibandronate sodium | TABLET;ORAL | 021455-001 | May 16, 2003 | 6,294,196 | Start Trial |
| Hoffmann La Roche | ACCUTANE | isotretinoin | CAPSULE;ORAL | 018662-002 | May 7, 1982 | 4,200,647 | 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 | For Oral Solution | 50 mg/mL | ➤ Subscribe | 2011-03-21 |
| ➤ Subscribe | Tablets | 2.5 mg and 150 mg | ➤ Subscribe | 2007-05-16 |
| ➤ 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 |
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 |
|---|---|---|
| Taiwan | 200404553 | Start Trial |
| Argentina | 061845 | Start Trial |
| Canada | 2613015 | Start Trial |
| China | 1326335 | Start Trial |
| Czech Republic | 20011233 | Start Trial |
| South Korea | 20120065435 | Start Trial |
| South Korea | 20120055586 | 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 |
|---|---|---|---|---|
| 1893612 | C20120016 00059 | Estonia | Start Trial | PRODUCT NAME: ZELBORAF - VEMURAFENIIB;REG NO/DATE: C(2012)1180 FINAL 17.02.2012 |
| 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 |
| 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 |
| 0034432 | 96C0048 | Belgium | Start Trial | PRODUCT NAME: SAQUINAVIR; REGISTRATION NO/DATE: EU/1/96/026/001 19961004 |
| 1893612 | 462 | Finland | Start Trial | |
| 1893612 | SPC/GB12/021 | United Kingdom | Start Trial | PRODUCT NAME: VEMURAFENIB AND PHARMACEUTICALLY ACCEPTABLE SALTS; REGISTERED: UK EU/1/12/751/001 20120221 |
| 0432695 | C970013 | Netherlands | Start Trial | PRODUCT NAME: SAQUINAVIR DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARD BAAR ZUURADDITIEZOUT, IN HET BIJZONDER HET MESYLAAT; REGISTRATION NO/DATE: EU/1/96/026/001 19961004 |
| >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.
