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Generated: August 20, 2018

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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 three US patents protecting RECKITT BENCKISER drugs.

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

Summary for Reckitt Benckiser
International Patents:37
US Patents:3
Tradenames:5
Ingredients:5
NDAs:5
Patent Litigation for Reckitt Benckiser: See patent lawsuits for Reckitt Benckiser

Drugs and US Patents for Reckitt Benckiser

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Reckitt Benckiser MUCINEX D guaifenesin; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 021585-002 Jun 22, 2004 OTC Yes Yes 6,372,252 ➤ Sign Up Y ➤ Sign Up
Reckitt Benckiser MUCINEX DM dextromethorphan hydrobromide; guaifenesin TABLET, EXTENDED RELEASE;ORAL 021620-001 Apr 29, 2004 OTC Yes Yes 7,838,032 ➤ Sign Up Y ➤ Sign Up
Reckitt Benckiser MUCINEX D guaifenesin; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 021585-001 Jun 22, 2004 OTC Yes No 6,372,252 ➤ Sign Up Y ➤ Sign Up
Reckitt Benckiser MUCINEX D guaifenesin; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 021585-002 Jun 22, 2004 OTC Yes Yes 6,955,821 ➤ Sign Up Y ➤ Sign Up
Reckitt Benckiser MUCINEX D guaifenesin; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 021585-001 Jun 22, 2004 OTC Yes No 7,838,032 ➤ Sign Up Y ➤ Sign Up
Reckitt Benckiser MUCINEX DM dextromethorphan hydrobromide; guaifenesin TABLET, EXTENDED RELEASE;ORAL 021620-002 Apr 29, 2004 OTC Yes No 6,372,252 ➤ Sign Up Y ➤ Sign Up
Reckitt Benckiser MUCINEX D guaifenesin; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 021585-001 Jun 22, 2004 OTC Yes No 6,955,821 ➤ Sign Up Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for Reckitt Benckiser

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Reckitt Benckiser DELSYM dextromethorphan polistirex SUSPENSION, EXTENDED RELEASE;ORAL 018658-001 Oct 8, 1982 4,221,778 ➤ Sign Up
Reckitt Benckiser DELSYM dextromethorphan polistirex SUSPENSION, EXTENDED RELEASE;ORAL 018658-001 Oct 8, 1982 5,980,882 ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for RECKITT BENCKISER drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Extended-release Suspension 30 mg/5 mL ➤ Subscribe 2009-01-12
➤ Subscribe Extended-release Tablets 600 mg/30 mg and 1200 mg/60 mg ➤ Subscribe 2008-12-17
➤ Subscribe Extended-release Tablets 600 mg and 1.2 gm ➤ Subscribe 2006-06-09

Non-Orange Book US 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
7,985,420 Sustained release of guaifenesin combination drugs ➤ Sign Up
8,012,504 Sustained release of guaifenesin combination drugs ➤ Sign Up
7,985,421 Sustained release formulations of guaifenesin and additional drug ingredients ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for Reckitt Benckiser Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0814 Netherlands ➤ Sign Up PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211
2016 00016 Denmark ➤ Sign Up PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211
/2015 Austria ➤ Sign Up PRODUCT NAME: ETHINYLESTRADIOL UND EINE KOMBINATION VON LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 136021 20150224; FIRST REGISTRATION: SK 17/0017/15-S 20150211
2013 00059 Denmark ➤ Sign Up PRODUCT NAME: KOMBINATION AF (A) DEXTROMETHORPHAN OG (B) QUNIDIN, HERUNDER DEXTROMETHORPHANHYDROBROMIDMONOHYDRAT OG QUINIDINSULFATDIHYDRAT; REG. NO/DATE: EU/1/13/833 20130624
156 Luxembourg ➤ Sign Up PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
323 Luxembourg ➤ Sign Up PRODUCT 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
C0062 France ➤ Sign Up PRODUCT 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

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Serving hundreds of leading biopharmaceutical companies globally:

AstraZeneca
Deloitte
Chubb
Cantor Fitzgerald
Medtronic
Boehringer Ingelheim
US Army
UBS
Queensland Health

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