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Generated: July 27, 2017
What is the competitive landscape for HOFFMANN LA ROCHE, and when can generic versions of HOFFMANN LA ROCHE drugs launch?
HOFFMANN LA ROCHE has fourteen approved drugs.| Patents: | 14 |
| Tradenames: | 12 |
| Ingredients: | 11 |
| NDAs: | 14 |
| 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 | ► Subscribe | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Hoffmann La Roche | ZELBORAF | vemurafenib | TABLET;ORAL | 202429-001 | Aug 17, 2011 | RX | Yes | Yes | ► Subscribe | ► Subscribe | Y | Y | ► Subscribe | ||||||||||||||||
Hoffmann La Roche | ACCUTANE | isotretinoin | CAPSULE;ORAL | 018662-003 | May 7, 1982 | DISCN | Yes | No | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
Hoffmann La Roche | ROCEPHIN | ceftriaxone sodium | INJECTABLE;INJECTION | 063239-003 | Aug 13, 1993 | DISCN | No | No | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
Hoffmann La Roche | BONIVA | ibandronate sodium | TABLET;ORAL | 021455-001 | May 16, 2003 | DISCN | Yes | No | ► Subscribe | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Hoffmann La Roche | XENICAL | orlistat | CAPSULE;ORAL | 020766-001 | Apr 23, 1999 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Hoffmann La Roche | ROMAZICON | flumazenil | INJECTABLE;INJECTION | 020073-001 | Dec 20, 1991 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Hoffmann La Roche | BONIVA | ibandronate sodium | TABLET;ORAL | 021455-001 | May 16, 2003 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Hoffmann La Roche | ACCUTANE | isotretinoin | CAPSULE;ORAL | 018662-004 | Mar 28, 1983 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Hoffmann La Roche | ACCUTANE | isotretinoin | CAPSULE;ORAL | 018662-004 | Mar 28, 1983 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
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| Drugname | Dosage | Strength | Tradename | Submissiondate |
|---|---|---|---|---|
valganciclovir hydrochloride | For Oral Solution | 50 mg/mL | VALCYTE | 3/21/2011 |
capecitabine | Tablets | 150 mg and 500 mg | XELODA | 11/10/2008 |
ibandronate sodium | Injection | 1 mg/mL, 3 mL Vial | BONIVA | 8/31/2007 |
ibandronate sodium | Tablets | 2.5 mg and 150 mg | BONIVA | 5/16/2007 |
valganciclovir hydrochloride | Tablets | 450 mg | VALCYTE | 12/27/2005 |
| Patent Number | Expiration Date |
|---|---|
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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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 9,663,517 | Compositions and uses thereof | ► Subscribe | |||||||||||||||||||||||||||
| 6,627,221 | Pharmaceutical composition containing diphosphonic acid or salt thereof | ► Subscribe | |||||||||||||||||||||||||||
| 7,846,941 | Compounds modulating c-kit and c-fms activity and uses therefor | ► Subscribe | |||||||||||||||||||||||||||
| 8,329,724 | Process for the manufacture of pharmaceutically active compounds | ► Subscribe | |||||||||||||||||||||||||||
| 8,415,469 | Compounds and methods for kinase modulation, and indications therefor | ► Subscribe | |||||||||||||||||||||||||||
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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.
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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Russian Federation | 2008100933 | ► Subscribe | |||||||||||||||||||||||||||
| Peru | 08762012 | ► Subscribe | |||||||||||||||||||||||||||
| Czech Republic | 9803364 | ► Subscribe | |||||||||||||||||||||||||||
| Argentina | 078519 | ► Subscribe | |||||||||||||||||||||||||||
| Serbia | 52457 | ► Subscribe | |||||||||||||||||||||||||||
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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.
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| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| /1996 | Austria | ► Subscribe | PRODUCT NAME: SAQUINAVIR UND SEINE SAEUREADDITIONSSALZE, INSBESONDERE SAQUINAVIRMESYLAT; REGISTRATION NO/DATE: EU/1/96/026/001 19961004 | ||||||||||||||||||||||||||
| 2012010 | Lithuania | ► Subscribe | PRODUCT NAME: VEMURAFENIBUM; REGISTRATION NO/DATE: EU/1/12/751/001 20120217 | ||||||||||||||||||||||||||
| 2012010,C1893612 | Lithuania | ► Subscribe | PRODUCT NAME: VEMURAFENIBUM; REGISTRATION NO/DATE: EU/1/12/751/001 20120217 | ||||||||||||||||||||||||||
| C0003 | France | ► Subscribe | PRODUCT NAME: VALGANCICLOVIR AINSI QUE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES ET EN PARTICULIER LE CHLORHYDRATE; NAT. REGISTRATION NO/DATE: NL 27380 20021016; FIRST REGISTRATION: NL - RVG 25 992 20010920 | ||||||||||||||||||||||||||
| 02/028 | Ireland | ► Subscribe | PRODUCT NAME: VALGANCICLOVIR (2-(2-AMINO-1,6-DIHYDRO-6-OXO-PURIN-9-YL)- METHOXY-3-HYDROXY-1-PROPANYL-L-VALINATE) AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; NAT REGISTRATION NO/DATE: 50/150/1 20020913; FIRST REGISTRATION NO/DATE: NL 25992 20010920; PAEDIATRIC INVESTIGATION PLAN: P/0220/2013 | ||||||||||||||||||||||||||
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Serving 500+ biopharmaceutical companies globally:
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.
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