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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Fuji
Farmers Insurance
Baxter
Daiichi Sankyo
Covington
QuintilesIMS
Cantor Fitzgerald
Julphar
US Department of Justice

Generated: November 19, 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 and sixty-six supplementary protection certificates in twelve countries.

Summary for Roche

International Patents:82
US 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
MENRIUM 5-2
chlordiazepoxide; estrogens, esterified
TABLET;ORAL014740-002Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Roche
TAMIFLU
oseltamivir phosphate
CAPSULE;ORAL021087-002Jul 2, 2007ABRXYesNo► Subscribe► SubscribeY► Subscribe
Roche
GANTRISIN
sulfisoxazole acetyl
SYRUP;ORAL009182-002Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Roche
GANTANOL
sulfamethoxazole
TABLET;ORAL012715-002Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Roche
AZO GANTANOL
phenazopyridine hydrochloride; sulfamethoxazole
TABLET;ORAL013294-001Sep 10, 1987DISCNYesNo► Subscribe► Subscribe► Subscribe
Roche
TARACTAN
chlorprothixene
INJECTABLE;INJECTION012487-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Roche
NOLUDAR
methyprylon
CAPSULE;ORAL009660-008Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Roche
TAMIFLU
oseltamivir phosphate
CAPSULE;ORAL021087-003Jul 2, 2007ABRXYesNo► Subscribe► Subscribe ► Subscribe
Roche
TRIMPEX
trimethoprim
TABLET;ORAL017952-001Approved 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
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Expired Patents for Roche

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Roche
KLONOPIN RAPIDLY DISINTEGRATING
clonazepam
TABLET, ORALLY DISINTEGRATING;ORAL020813-002Dec 23, 1997► Subscribe► Subscribe
Roche
VALIUM
diazepam
TABLET;ORAL013263-006Approved Prior to Jan 1, 1982► Subscribe► Subscribe
Roche
KYTRIL
granisetron hydrochloride
INJECTABLE;INJECTION020239-001Dec 29, 1993► Subscribe► Subscribe
Roche
DEMADEX
torsemide
INJECTABLE;INJECTION020137-002Aug 23, 1993► Subscribe► Subscribe
Roche Palo
FEMSTAT
butoconazole nitrate
CREAM;VAGINAL019215-001Nov 25, 1985► Subscribe► Subscribe
Roche
KYTRIL
granisetron hydrochloride
SOLUTION;ORAL021238-001Jun 27, 2001► Subscribe► Subscribe
Roche Palo
TORADOL
ketorolac tromethamine
TABLET;ORAL019645-001Dec 20, 1991► Subscribe► Subscribe
Roche
TAMIFLU
oseltamivir phosphate
FOR SUSPENSION;ORAL021246-002Mar 21, 2011► Subscribe► Subscribe
Roche Palo
CYTOVENE
ganciclovir sodium
INJECTABLE;INJECTION019661-001Jun 23, 1989► Subscribe► Subscribe
Roche
KLONOPIN
clonazepam
TABLET;ORAL017533-002Approved Prior to Jan 1, 1982► 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
Hungary229200► Subscribe
Japan3792251► Subscribe
United Kingdom9305593► Subscribe
Denmark0976734► Subscribe
World Intellectual Property Organization (WIPO)9421257► Subscribe
Taiwan426663► Subscribe
JapanH08507774► Subscribe
New Zealand306625► Subscribe
JapanH11501908► Subscribe
Czech Republic9702690► 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
1740177/02Switzerland► SubscribePRODUCT NAME: UMECLIDINIUM BROMID + VILANTEROL; REGISTRATION NO/DATE: SWISSMEDIC 63152 14.07.2014
C/GB05/026United Kingdom► SubscribePRODUCT NAME: ENFUVIRTIDE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR ESTER; REGISTERED: CH CH 56,282 20030430; UK EU/1/03/252/001 20030527; UK EU/1/03/252/002 20030527; UK EU/1/03/252/003 20030527
/2015Austria► SubscribePRODUCT NAME: PHENYLEPHRIN, ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, UND KETOROLAC, ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1018 (MITTEILUNG) 20150730
1740177/03Switzerland► SubscribePRODUCT NAME: UMECLIDINIUM BROMID; REGISTRATION NO/DATE: SWISSMEDIC 63152 14.07.2014
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
C0005Belgium► SubscribePRODUCT NAME: FOSPHENYTOIN DISODIUM; NAT. REGISTRATION NO/DATE: NL 23 613 19980806; FIRST REGISTRATION: GB - PL 000 19/0157 19980204
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
C0022France► SubscribePRODUCT NAME: MONTELUKAST SODIUM; REGISTRATION NO/DATE IN FRANCE: NL 23 133 DU 19980320; REGISTRATION NO/DATE AT EEC: 13 651 DU 19970825
C0055France► SubscribePRODUCT NAME: SULFATE DE SODIUM ANHYDRE, SULFATE DE MAGNESIUM HEPTAHYDRATE, SULFATE DE POTASSIUM; NAT. REGISTRATION NO/DATE: NL41696 20130426; FIRST REGISTRATION: 434323 20130220
1200431/01Switzerland► SubscribePRODUCT NAME: ACLIDINIUM; REGISTRATION NO/DATE: SWISSMEDIC 62590 25.04.2013
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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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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Novartis
Chinese Patent Office
Fish and Richardson
Mallinckrodt
US Army
US Department of Justice
Healthtrust
Federal Trade Commission
Dow

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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