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Rb Hlth Company Profile

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

RB HLTH has four approved drugs.

There are three US patents protecting RB HLTH drugs.

There are thirty-seven patent family members on RB HLTH drugs in nineteen countries and six supplementary protection certificates in five countries.

Summary for Rb Hlth

International Patents:	37
US Patents:	3
Tradenames:	4
Ingredients:	4
NDAs:	4

Drugs and US Patents for Rb Hlth

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Rb Hlth	MUCINEX	guaifenesin	TABLET, EXTENDED RELEASE;ORAL	021282-001	Jul 12, 2002		OTC	Yes	No	6,372,252
Rb Hlth	MUCINEX	guaifenesin	TABLET, EXTENDED RELEASE;ORAL	021282-001	Jul 12, 2002		OTC	Yes	No	7,838,032		Y
Rb Hlth	MUCINEX	guaifenesin	TABLET, EXTENDED RELEASE;ORAL	021282-002	Dec 18, 2002		OTC	Yes	Yes	6,372,252
Rb Hlth	MUCINEX D	guaifenesin; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021585-001	Jun 22, 2004		OTC	Yes	No	6,955,821		Y
Rb Hlth	MUCINEX DM	dextromethorphan hydrobromide; guaifenesin	TABLET, EXTENDED RELEASE;ORAL	021620-002	Apr 29, 2004		OTC	Yes	No	7,838,032		Y
Rb Hlth	MUCINEX DM	dextromethorphan hydrobromide; guaifenesin	TABLET, EXTENDED RELEASE;ORAL	021620-001	Apr 29, 2004		OTC	Yes	Yes	7,838,032		Y

Expired US Patents for Rb Hlth

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

Paragraph IV (Patent) Challenges for RB HLTH drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Extended-release Suspension	30 mg/5 mL		2009-01-12
	Extended-release Tablets	600 mg/30 mg and 1200 mg/60 mg		2008-12-17
	Extended-release Tablets	600 mg and 1.2 gm		2006-06-09

International Patents for Rb Hlth Drugs

Country	Document Number	Estimated Expiration
New Zealand	521959
Japan	2003531849
Taiwan	I314866
Hong Kong	1052651
South Africa	200409171
Portugal	1276467

Supplementary Protection Certificates for Rb Hlth Drugs

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
13/055	Ireland		PRODUCT 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
C0062	France		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
323	Luxembourg		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
/2013	Austria		PRODUCT 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
2013 00059	Denmark		PRODUCT NAME: KOMBINATION AF (A) DEXTROMETHORPHAN OG (B) QUNIDIN, HERUNDER DEXTROMETHORPHANHYDROBROMIDMONOHYDRAT OG QUINIDINSULFATDIHYDRAT; REG. NO/DATE: EU/1/13/833 20130624
2013 00059	Denmark		PRODUCT NAME: KOMBINATION AF (A) DEXTROMETHORPHAN OG (B) QUNIDIN, HERUNDER DEXTROMETHORPHANHYDROBROMIDMONOHYDRAT OG QUINIDINSULFATDIHYDRAT; REG. NO/DATE: EU/1/13/833 20130624

Similar Applicant Names

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

• Rb Hlth