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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?
There are thirteen US patents protecting HOFFMANN LA ROCHE drugs.
There are three hundred and forty-three patent family members on HOFFMANN LA ROCHE drugs in fifty-one countries and twenty-six supplementary protection certificates in fifteen countries.
Summary for Hoffmann La Roche
| International Patents: | 343 |
| 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 | ZELBORAF | vemurafenib | TABLET;ORAL | 202429-001 | Aug 17, 2011 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | |||||
| Hoffmann La Roche | ROCEPHIN | ceftriaxone sodium | INJECTABLE;INJECTION | 063239-002 | Aug 13, 1993 | DISCN | No | No | ➤ Sign Up | ➤ Sign Up | |||||
| Hoffmann La Roche | ZELBORAF | vemurafenib | TABLET;ORAL | 202429-001 | Aug 17, 2011 | RX | Yes | Yes | 7,863,288 | ➤ Sign Up | Y | Y | ➤ Sign Up | ||
| Hoffmann La Roche | ROCEPHIN KIT | ceftriaxone sodium; lidocaine | INJECTABLE;INJECTION | 050585-007 | May 8, 1996 | DISCN | No | No | ➤ Sign Up | ➤ Sign Up | |||||
| 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 | ➤ Sign Up |
| Hoffmann La Roche | ACCUTANE | isotretinoin | CAPSULE;ORAL | 018662-004 | Mar 28, 1983 | 4,200,647 | ➤ Sign Up |
| Hoffmann La Roche | FORTOVASE | saquinavir | CAPSULE;ORAL | 020828-001 | Nov 7, 1997 | 5,196,438*PED | ➤ Sign Up |
| Hoffmann La Roche | ACCUTANE | isotretinoin | CAPSULE;ORAL | 018662-004 | Mar 28, 1983 | 4,335,125 | ➤ Sign Up |
| 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 | 150 mg and 500 mg | ➤ Subscribe | 2008-11-10 |
| ➤ Subscribe | Tablets | 2.5 mg and 150 mg | ➤ Subscribe | 2007-05-16 |
| ➤ Subscribe | For Oral Solution | 50 mg/mL | ➤ Subscribe | 2011-03-21 |
| ➤ Subscribe | Injection | 1 mg/mL, 3 mL Vial | ➤ Subscribe | 2007-08-31 |
| ➤ Subscribe | Tablets | 450 mg | ➤ Subscribe | 2005-12-27 |
Premature patent expirations for HOFFMANN LA ROCHE
Non-Orange Book US Patents for Hoffmann La Roche
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 |
|---|---|---|
| 8,415,469 | Compounds and methods for kinase modulation, and indications therefor | ➤ Sign Up |
| 9,663,517 | Compositions and uses thereof | ➤ Sign Up |
| 6,627,221 | Pharmaceutical composition containing diphosphonic acid or salt thereof | ➤ Sign Up |
| 7,846,941 | Compounds modulating c-kit and c-fms activity and uses therefor | ➤ Sign Up |
| Patent No. | Title | Estimated Patent Expiration |
International Patents for Hoffmann La Roche Drugs
Supplementary Protection Certificates for Hoffmann La Roche Drugs
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 12/025 | Ireland | ➤ Sign Up | PRODUCT NAME: VEMURAFENIB AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/12/751/001 20120217 |
| 1893612/01 | Switzerland | ➤ Sign Up | PRODUCT NAME: VEMURAFENIB; REGISTRATION NO/DATE: SWISSMEDIC 62139 18.10.2011 |
| C/GB12/021 | United Kingdom | ➤ Sign Up | PRODUCT NAME: VEMURAFENIB AND PHARMACEUTICALLY ACCEPTABLE SALTS; REGISTERED: UK EU/1/12/751/001 20120221 |
| 2 5012-2012 | Slovakia | ➤ Sign Up | FIRST REGISTRATION NO/DATE: EU/1/12/751/001, 20120217 |
| 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.
