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BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Fuji
Accenture
Boehringer Ingelheim
Teva
Colorcon
Dow
Fish and Richardson
Chubb
Novartis
Harvard Business School

Generated: November 24, 2017

DrugPatentWatch Database Preview

Reckitt Benckiser Company Profile

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What is the competitive landscape for RECKITT BENCKISER, and when can generic versions of RECKITT BENCKISER drugs launch?

RECKITT BENCKISER has five approved drugs.

There are four US patents protecting RECKITT BENCKISER drugs.

There are thirty-nine patent family members on RECKITT BENCKISER drugs in nineteen countries and eleven supplementary protection certificates in seven countries.

Summary for Reckitt Benckiser

International Patents:39
US Patents:4
Tradenames:5
Ingredients:5
NDAs:5
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Reckitt Benckiser
LEVONORGESTREL
levonorgestrel
TABLET;ORAL202246-001Jun 5, 2015OTCNoNo► Subscribe► Subscribe► Subscribe
Reckitt Benckiser
MUCINEX
guaifenesin
TABLET, EXTENDED RELEASE;ORAL021282-002Dec 18, 2002OTCYesYes► Subscribe► SubscribeY ► Subscribe
Reckitt Benckiser
MUCINEX
guaifenesin
TABLET, EXTENDED RELEASE;ORAL021282-002Dec 18, 2002OTCYesYes► Subscribe► SubscribeY ► Subscribe
Reckitt Benckiser
MUCINEX
guaifenesin
TABLET, EXTENDED RELEASE;ORAL021282-001Jul 12, 2002OTCYesNo► Subscribe► SubscribeY ► Subscribe
Reckitt Benckiser
MUCINEX DM
dextromethorphan hydrobromide; guaifenesin
TABLET, EXTENDED RELEASE;ORAL021620-002Apr 29, 2004OTCYesNo► Subscribe► SubscribeY ► Subscribe
Reckitt Benckiser
MUCINEX D
guaifenesin; pseudoephedrine hydrochloride
TABLET, EXTENDED RELEASE;ORAL021585-001Jun 22, 2004OTCYesNo► Subscribe► SubscribeY ► Subscribe
Reckitt Benckiser
MUCINEX D
guaifenesin; pseudoephedrine hydrochloride
TABLET, EXTENDED RELEASE;ORAL021585-002Jun 22, 2004OTCYesYes► Subscribe► SubscribeY ► Subscribe
Reckitt Benckiser
MUCINEX DM
dextromethorphan hydrobromide; guaifenesin
TABLET, EXTENDED RELEASE;ORAL021620-001Apr 29, 2004OTCYesYes► Subscribe► SubscribeY ► Subscribe
Reckitt Benckiser
MUCINEX
guaifenesin
TABLET, EXTENDED RELEASE;ORAL021282-001Jul 12, 2002OTCYesNo► Subscribe► Subscribe ► Subscribe
Reckitt Benckiser
MUCINEX D
guaifenesin; pseudoephedrine hydrochloride
TABLET, EXTENDED RELEASE;ORAL021585-001Jun 22, 2004OTCYesNo► Subscribe► SubscribeY ► Subscribe
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Expired Patents for Reckitt Benckiser

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Reckitt Benckiser
DELSYM
dextromethorphan polistirex
SUSPENSION, EXTENDED RELEASE;ORAL018658-001Oct 8, 1982► Subscribe► Subscribe
Reckitt Benckiser
DELSYM
dextromethorphan polistirex
SUSPENSION, EXTENDED RELEASE;ORAL018658-001Oct 8, 1982► Subscribe► Subscribe
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Paragraph IV activity for RECKITT BENCKISER drugs

Drugname Dosage Strength Tradename Submissiondate
dextromethorphan polistirex
Extended-release Suspension30 mg/5 mL
DELSYM
1/12/2009
guaifenesin and dextromethorphan
Extended-release Tablets600 mg/30 mg and 1200 mg/60 mg
MUCINEX DM
12/17/2008
guaifenesin
Extended-release Tablets600 mg and 1.2 gm
MUCINEX
6/9/2006

Non-Orange Book Patents for Reckitt Benckiser

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
7,985,420Sustained release of guaifenesin combination drugs► Subscribe
8,012,504Sustained release of guaifenesin combination drugs► Subscribe
7,985,421Sustained release formulations of guaifenesin and additional drug ingredients► 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 Reckitt Benckiser Drugs

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO)03088952► Subscribe
European Patent Office1503739► Subscribe
Hong Kong1052651► Subscribe
Japan5466346► Subscribe
South Africa200409171► Subscribe
Portugal1276467► Subscribe
Australia2003237807► Subscribe
Israel164438► Subscribe
Canada2405031► Subscribe
Israel190742► 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 Reckitt Benckiser Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
/2013Austria► SubscribePRODUCT NAME: KOMBINATION VON A) DEXTROMETHORPHAN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, BEISPIELSWEISE DEXTROMETHORPHANHYDROBROMID, UND INSBESONDERE DEXTROMETHORPHANHYDROBROMIDMONOHYDRAT UND B) CHINIDIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, BEISPIELSWEISE CHINIDINSULFAT, UND INSBESONDERE CHINIDINSULFATDIHYDRAT.; REGISTRATION NO/DATE: EU/1/13/833 20130626
0814Netherlands► SubscribePRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211
/2015Austria► SubscribePRODUCT NAME: ETHINYLESTRADIOL UND EINE KOMBINATION VON LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 136021 20150224; FIRST REGISTRATION: SK 17/0017/15-S 20150211
2015000093Germany► SubscribePRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
C0062France► SubscribePRODUCT NAME: (A) DEXTROMETHORPHAN OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE, PAR EXEMPLE LE BROMHYDRATE DE DEXTROMETHORPHAN ET EN PARTICULIER LE MONOHYDRATE DE BROMHYDRATE DE DEXTROMETHORPHAN (B) QUINIDINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE, PAR EXEMPLE LE SULFATE DE QUINIDINE EN PARTICULIER LE DIHYDRATE DE SULFATE DE QUINIDINE; REGISTRATION NO/DATE: EU/1/13/833/001-003 20130626
156Luxembourg► SubscribePRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
13/055Ireland► SubscribePRODUCT NAME: THE COMBINATION OF: (A) DEXTROMETHORPHAN OR A PHARMACEUTICALLY ACCEPTABLE SALT, PRECURSOR OR DERIVATIVE THEREOF, E.G. DEXTROMETHORPHAN HYDROBROMIDE AND IN PARTICULAR DEXTROMETHORPHAN HYDROBROMIDE MONOHYDRATE; AND (B) QUINIDINE OR A PHARMACEUTICALLY ACCEPTABLE SALT, PRECURSOR OR DERIVATIVE THEREOF, E.G. QUINIDINE SULPHATE AND IN PARTICULAR QUINIDINE SULPHATE DIHYDRATE, PROTECTED BY THE BASIC PATENT; REGISTRATION NO/DATE: EU/1/13/833 20130624
2013 00059Denmark► SubscribePRODUCT NAME: KOMBINATION AF (A) DEXTROMETHORPHAN OG (B) QUNIDIN, HERUNDER DEXTROMETHORPHANHYDROBROMIDMONOHYDRAT OG QUINIDINSULFATDIHYDRAT; REG. NO/DATE: EU/1/13/833 20130624
2016 00016Denmark► SubscribePRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211
323Luxembourg► SubscribePRODUCT NAME: LA COMBINAISON DE (A) DEXTROMETHORPHAN OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, PRECURSEURS OU DERIVES , PAR EX. HYDROBROMURE DE DEXTROMETHORPHAN ET EN PARTICULIER HYDROBROMURE DE DEXTROMETHORPHAN MONOHYDRATE; ET(B) QUINIDINE OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES , PRECURSEURS OU DERIVES, PAR EX. SULFATE DE QUINIDINE ET EN PARTICULIER SULFATE DE QUINIDINE DEHYDRATE; FIRST REGISTRATION: 20130624
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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:

Harvard Business School
Cerilliant
US Department of Justice
Covington
Argus Health
Chinese Patent Office
Medtronic
Colorcon
Deloitte
US Army

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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