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Warner Chilcott Company Profile

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

WARNER CHILCOTT has eighty-four approved drugs.

There are five US patents protecting WARNER CHILCOTT drugs.

There are one hundred and twenty-one patent family members on WARNER CHILCOTT drugs in forty-four countries and fifty-six supplementary protection certificates in eleven countries.

Summary for Warner Chilcott

International Patents:	121
US Patents:	5
Tradenames:	42
Ingredients:	39
NDAs:	84
Patent Litigation for Warner Chilcott:	See patent lawsuits for Warner Chilcott
PTAB Cases with Warner Chilcott as patent owner:	See PTAB cases with Warner Chilcott as patent owner

Drugs and US Patents for Warner Chilcott

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Warner Chilcott	ALBUTEROL SULFATE	albuterol sulfate	TABLET;ORAL	072818-001	Jan 9, 1990		DISCN	No	No
Warner Chilcott	ACTONEL WITH CALCIUM (COPACKAGED)	calcium carbonate; risedronate sodium	TABLET, TABLET;ORAL	021823-001	Aug 12, 2005		DISCN	Yes	No	6,465,443*PED				Y
Warner Chilcott	ACETAMINOPHEN AND CODEINE PHOSPHATE	acetaminophen; codeine phosphate	TABLET;ORAL	087306-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Warner Chilcott	CARBAMAZEPINE	carbamazepine	TABLET;ORAL	070429-001	Jan 2, 1987		DISCN	No	No

Expired US Patents for Warner Chilcott

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Warner Chilcott	ACTONEL WITH CALCIUM (COPACKAGED)	calcium carbonate; risedronate sodium	TABLET, TABLET;ORAL	021823-001	Aug 12, 2005	5,583,122*PED
Warner Chilcott	ACTONEL WITH CALCIUM (COPACKAGED)	calcium carbonate; risedronate sodium	TABLET, TABLET;ORAL	021823-001	Aug 12, 2005	6,096,342*PED

Paragraph IV (Patent) Challenges for WARNER CHILCOTT drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Delayed-release Tablets	150 mg		2008-12-19
	Delayed-release Tablets	200 mg		2014-05-19
	Delayed-release Tablets	50 mg		2015-11-05
	Delayed-release Tablets	200 mg		2013-08-12
	Delayed-release Tablets	80 mg		2015-07-01

Non-Orange Book US Patents for Warner Chilcott

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
6,569,460	Film-coated tablet for improved upper gastrointestinal tract safety
6,544,967	Method for inhibiting bone resorption
6,225,294	Method for inhibiting bone resorption
6,333,316	Method for inhibiting bone resorption

International Patents for Warner Chilcott Drugs

Country	Document Number	Estimated Expiration
United Kingdom	9717850
South Africa	9806479
United Kingdom	9819243
European Patent Office	1175903

Supplementary Protection Certificates for Warner Chilcott Drugs

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0814	Netherlands		PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211
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
2016 00016	Denmark		PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211
C/GB02/037	United Kingdom		PRODUCT NAME: TELMISARTAN, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, AND HYDROCHLOROTHIAZIDE; REGISTERED: UK EU/1/02/213/001 20020419; UK EU/1/02/213/002 20020419; UK EU/1/02/213/003 20020419; UK EU/1/02/214/004 20020419; UK EU/1/02/213/005 20020419; UK EU/1/02/213/006 20020419; UK EU/1/02/213/007 20020419; UK EU/1/02/213/008 20020419; UK EU/1/02/213/009 20020419; UK EU/1/02/213/010 20020419

Similar Applicant Names

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

• Warner Chilcott
• Warner Chilcott Llc