Cosette Company Profile

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

COSETTE has one hundred and twenty-three approved drugs.

There are five US patents protecting COSETTE drugs.

There are seventy-six patent family members on COSETTE drugs in twenty-six countries and ninety-two supplementary protection certificates in fourteen countries.

Summary for Cosette

International Patents:	76
US Patents:	5
Tradenames:	73
Ingredients:	68
NDAs:	123

Drugs and US Patents for Cosette

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cosette	WELCHOL	colesevelam hydrochloride	CAPSULE;ORAL	021141-001	May 26, 2000		DISCN	No	No
Cosette	ACEPHEN	acetaminophen	SUPPOSITORY;RECTAL	072237-001	Mar 27, 1992		DISCN	No	No
Cosette	GENTAMICIN SULFATE	gentamicin sulfate	CREAM;TOPICAL	064056-001	Apr 29, 1994	AT	RX	No	No
Cosette	BETA-VAL	betamethasone valerate	LOTION;TOPICAL	070072-001	Jun 27, 1985		DISCN	No	No
Cosette	BETAMETHASONE DIPROPIONATE	betamethasone dipropionate	LOTION;TOPICAL	071882-001	Jun 6, 1988		DISCN	No	No
Cosette	VAGILIA	triple sulfa (sulfabenzamide;sulfacetamide;sulfathiazole)	CREAM;VAGINAL	088821-001	Nov 9, 1987		DISCN	No	No

Expired US Patents for Cosette

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cosette	WELCHOL	colesevelam hydrochloride	TABLET;ORAL	021176-001	May 26, 2000	5,693,675*PED
Cosette	WELCHOL	colesevelam hydrochloride	FOR SUSPENSION;ORAL	022362-002	Oct 2, 2009	5,679,717*PED
Cosette	AZOR	amlodipine besylate; olmesartan medoxomil	TABLET;ORAL	022100-001	Sep 26, 2007	5,616,599*PED
Cosette	BENICAR	olmesartan medoxomil	TABLET;ORAL	021286-001	Apr 25, 2002	5,616,599*PED
Cosette	WELCHOL	colesevelam hydrochloride	CAPSULE;ORAL	021141-001	May 26, 2000	5,919,832*PED
Cosette	WELCHOL	colesevelam hydrochloride	TABLET;ORAL	021176-001	May 26, 2000	6,433,026*PED

Paragraph IV (Patent) Challenges for COSETTE drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	For Injection	500 mg/vial		2004-04-16
	Tablets	10 mg/20 mg and 5 mg/40 mg		2008-03-31
	Tablets	20 mg/12.5 mg		2007-05-11
	Tablets	5 mg and 10 mg		2013-07-10
	Tablets	625 mg		2009-07-01
	Capsules	30 mg		2009-02-27
	Tablets	5 mg/20 mg and 10 mg/40 mg		2008-02-11
	Tablets	5 mg, 20 mg and 40 mg		2006-04-25
	Tablets	40 mg/12.5 mg and 40 mg/25 mL		2007-02-15
	Powder for Oral Suspension	1.875 g/Packet and 3.75 g/Packet		2010-04-09

International Patents for Cosette Drugs

Country	Patent Number	Estimated Expiration
Denmark	2916856
Mexico	PA02000111
Japan	2016503406
Canada	2568218
Canada	2574605
European Patent Office	1196184

Supplementary Protection Certificates for Cosette Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0284288	12/1998	Austria		PRODUCT NAME: TAZAROTENE; NAT. REGISTRATION NO/DATE: 1-22102, 1-22103 19970918; FIRST REGISTRATION: DE 37393.00.00, 37393.01.00 19961203
0503785	C300486	Netherlands		PRODUCT NAME: COMBINATIE VAN OLMESARTANMEDOXOMIL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, AMLODIPINEBESYLAAT AND HYDROCHLOORTHIAZIDE; NATL REGISTRATION NO/DATE: RVG 106667, RVG 106671-74, RVG 106682-86 20101221; FIRST REGISTRATION: DE 79810.00.00-79814.00.00 20101216
1539166	13C0062	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
1539166	2013/055	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
1507558	2012/018	Ireland		PRODUCT NAME: ALISKIREN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, AMLODIPINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND HYDROCHLOROTHIAZIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; NAT REGISTRATION NO/DATE: EU/1/11/730/001-060 20111122; FIRST REGISTRATION NO/DATE: SWITZERLAND 6167801-6167805 20110705
0347066	SPC/GB02/049	United Kingdom		PRODUCT NAME: ESCITALOPRAM OXALATE; REGISTERED: SE 17084/85/86/87 20011207; UK PL 13761/0008 20020610; UK PC 13761/0009 20020610; UK PL 13761/0010 20020610; UK PL 13761/0011 20020610; UK PL 13761/0012 20020610; UK PL 13761/0013 20020610; UK PL 13761/00014 20020610; UK PL 13761/0015 20020610

Similar Applicant Names

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

• Cosette