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Serving 500+ biopharmaceutical companies globally:

Argus Health
Teva
Farmers Insurance
Boehringer Ingelheim
Medtronic
Chinese Patent Office
Deloitte
UBS
QuintilesIMS
Cipla

Generated: September 26, 2017

DrugPatentWatch Database Preview

Roche Company Profile

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What is the competitive landscape for ROCHE, and what generic alternatives to ROCHE drugs are available?

ROCHE has sixty-four approved drugs.

There are three US patents protecting ROCHE drugs on ROCHE drugs in the past three years.

There are eighty-two patent family members on ROCHE drugs in thirty-three countries.

Summary for Applicant: Roche

Patents:3
Tradenames:50
Ingredients:46
NDAs:64
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Roche
ROCEPHIN
ceftriaxone sodium
INJECTABLE;INJECTION062510-002Mar 12, 1985DISCNNoNo► Subscribe► Subscribe► Subscribe
Roche
BEROCCA PN
ascorbic acid; biotin; cyanocobalamin; dexpanthenol; ergocalciferol; folic acid; niacinamide; pyridoxine hydrochloride; riboflavin 5'-phosphate sodium; thiamine hydrochloride; vitamin a palmitate; vitamin e
INJECTABLE;INJECTION006071-003Oct 10, 1985DISCNNoNo► Subscribe► Subscribe► Subscribe
Roche
KYTRIL
granisetron hydrochloride
INJECTABLE;INJECTION020239-003Sep 17, 2004DISCNYesNo► Subscribe► Subscribe► Subscribe
Roche
NOLUDAR
methyprylon
TABLET;ORAL009660-004Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Roche
AZO GANTRISIN
phenazopyridine hydrochloride; sulfisoxazole
TABLET;ORAL019358-001Aug 31, 1990DISCNYesNo► Subscribe► Subscribe► Subscribe
Roche
VALRELEASE
diazepam
CAPSULE, EXTENDED RELEASE;ORAL018179-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Roche
ENDEP
amitriptyline hydrochloride
TABLET;ORAL083639-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Roche
ARFONAD
trimethaphan camsylate
INJECTABLE;INJECTION008983-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Roche
MENRIUM 5-4
chlordiazepoxide; estrogens, esterified
TABLET;ORAL014740-004Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Roche Palo
CELLCEPT
mycophenolate mofetil
SUSPENSION;ORAL050759-001Oct 1, 1998ABRXYesYes► Subscribe► Subscribe► Subscribe
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Expired Patents for Roche

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Roche Palo
TICLID
ticlopidine hydrochloride
TABLET;ORAL019979-002Oct 31, 1991► Subscribe► Subscribe
Roche
FUZEON
enfuvirtide
INJECTABLE;SUBCUTANEOUS021481-001Mar 13, 2003► Subscribe► Subscribe
Roche
VALRELEASE
diazepam
CAPSULE, EXTENDED RELEASE;ORAL018179-001Approved Prior to Jan 1, 1982► Subscribe► Subscribe
Roche Palo
TICLID
ticlopidine hydrochloride
TABLET;ORAL019979-002Oct 31, 1991► Subscribe► Subscribe
Roche Palo
TICLID
ticlopidine hydrochloride
TABLET;ORAL019979-001Mar 24, 1993► Subscribe► Subscribe
Roche Palo
TICLID
ticlopidine hydrochloride
TABLET;ORAL019979-001Mar 24, 1993► Subscribe► Subscribe
Roche Palo
CELLCEPT
mycophenolate mofetil
TABLET;ORAL050723-001Jun 19, 1997► Subscribe► Subscribe
Roche Palo
CYTOVENE
ganciclovir
CAPSULE;ORAL020460-002Dec 12, 1997► Subscribe► Subscribe
Roche Palo
AEROBID
flunisolide
AEROSOL, METERED;INHALATION018340-001Aug 17, 1984► Subscribe► Subscribe
Roche Palo
CYTOVENE
ganciclovir
CAPSULE;ORAL020460-002Dec 12, 1997► Subscribe► Subscribe
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Paragraph IV activity for ROCHE drugs

Drugname Dosage Strength Tradename Submissiondate
oseltamivir phosphate
Oral Suspension6 mg/mL
TAMIFLU
6/18/2015
oseltamivir phosphate
Capsules30 mg and 45 mg
TAMIFLU
8/2/2011
mycophenolic mofetil
For Oral Suspension200 mg/mL
CELLCEPT
3/25/2011
oseltamivir phosphate
Capsule75 mg
TAMIFLU
11/15/2010
ibandronate sodium
Injection1 mg/mL, 3 mL Vial
BONIVA
8/31/2007
ibandronate sodium
Tablets2.5 mg and 150 mg
BONIVA
5/16/2007
granisetron hydrochloride
Injection0.1 mg/mL, 1 mL single dose vial
KYTRIL
3/8/2007
granisetron hydrochloride
Injection1 mg/mL, 4 mL multi-dose vials
KYTRIL
7/19/2004
granisetron hydrochloride
Injection1 mg/mL, 1 mL vials
KYTRIL
6/1/2004

Non-Orange Book Patents for 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
5,952,375 Compounds and methods for synthesis and therapy► Subscribe
6,225,341 Compounds and methods for synthesis and therapy► 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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International Patent Family for Roche Drugs

Country Document Number Estimated Expiration
China1185223► Subscribe
Austria230596► Subscribe
Austria305453► Subscribe
China1085079► Subscribe
Slovenia9620042► Subscribe
Spain2188611► Subscribe
Hong Kong1046359► Subscribe
Hong Kong1012237► Subscribe
JapanH11501908► Subscribe
Singapore46724► 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.

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Supplementary Protection Certificates for Roche Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0031Belgium► SubscribePRODUCT NAME: MYCOPHENOLATE MOFETIL; NAT. REGISTRATION NO/DATE: EU/1/96/005/001 19960214; FIRST REGISTRATION: CH 53337 19951103
C0055France► SubscribePRODUCT NAME: SULFATE DE SODIUM ANHYDRE, SULFATE DE MAGNESIUM HEPTAHYDRATE, SULFATE DE POTASSIUM; NAT. REGISTRATION NO/DATE: NL41696 20130426; FIRST REGISTRATION: 434323 20130220
666Luxembourg► SubscribePRODUCT NAME: DASABUVIR OU UN SEL QUI EN DERIVE, Y COMPRIS DASABUVIR SODIUMMONOHYDRATE. FIRST REGISTRATION: 20150119
1740177/03Switzerland► SubscribePRODUCT NAME: UMECLIDINIUM BROMID; REGISTRATION NO/DATE: SWISSMEDIC 63152 14.07.2014
595Luxembourg► SubscribePRODUCT NAME: SIMEPREVIR, OU L UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, INCLUANT SIMEPREVIR SODIUM. FIRST REGISTRATION: 20140516
C0001France► SubscribePRODUCT NAME: SEL D'ACLIDINIUM AVEC UN ANION PHARMACEUTIQUEMENT ACCEPTABLE D'UN ACIDE MONO OU POLYVALENT, EN PARTICULIER LE BROMURE D'ACLIDINIUM; REGISTRATION NO/DATE: EU/1/12/778/001-003 20120720
C/GB98/025United Kingdom► SubscribePRODUCT NAME: MONTELUKAST, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, PREFERABLY MONTELUKAST SODIUM; REGISTERED: FI 12766 19970825; FI 12767 19970825; UK 00025/0357 19980115; UK 00025/0358 19980115
C/GB00/021United Kingdom► SubscribePRODUCT NAME: (1-HYDROXY-2-(3-PYRIDINYL)ETHYLIDENE)BIS(PHOSPHONIC ACID) "RESIDRONATE" AND SALTS THEREOF, ESPECIALLY THE SODIUM SALT; REGISTERED: SE 15296 19991007; SE 15297 19991007; UK PL 00364/0070 20000316
C0075France► SubscribePRODUCT NAME: BROMURE D'UMECLIDINIUM; REGISTRATION NO/DATE: EU/1/14/922 001-003 20140428
00071Netherlands► SubscribePRODUCT NAME: VALGANCICLOVIR, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET HYDROCHLORIDE; REGISTRATION NO/DATE: RVG 25992 20010920
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Similar Applicant Names

Individual applicants are sometimes listed under multiple names.
Here is a list of applicants with similar names.

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

Serving 500+ biopharmaceutical companies globally:

Colorcon
Fish and Richardson
Healthtrust
Merck
Queensland Health
QuintilesIMS
Chubb
Deloitte
US Army
UBS

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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ISSN: 2162-2639

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