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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Julphar
Moodys
Boehringer Ingelheim
Teva
Queensland Health
UBS
Deloitte
Colorcon
Accenture

Generated: November 23, 2017

DrugPatentWatch Database Preview

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 and there have been two Paragraph IV challenges on WARNER CHILCOTT drugs in the past three years.

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

Summary for Warner Chilcott

International Patents:120
US Patents:5
Tradenames:42
Ingredients:39
NDAs:84
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Warner Chilcott
HYDROCHLOROTHIAZIDE
hydrochlorothiazide
TABLET;ORAL087586-001May 3, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Warner Chilcott
AMITRIL
amitriptyline hydrochloride
TABLET;ORAL085093-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Warner Chilcott
CLORAZEPATE DIPOTASSIUM
clorazepate dipotassium
CAPSULE;ORAL071775-001Mar 1, 1988DISCNNoNo► Subscribe► Subscribe► Subscribe
Warner Chilcott
DIAZEPAM
diazepam
INJECTABLE;INJECTION071614-001Oct 22, 1987DISCNNoNo► Subscribe► Subscribe► Subscribe
Warner Chilcott
CYCLOPAR
tetracycline hydrochloride
CAPSULE;ORAL062332-002Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Warner Chilcott
CLORAZEPATE DIPOTASSIUM
clorazepate dipotassium
TABLET;ORAL071828-001Mar 3, 1988DISCNNoNo► Subscribe► Subscribe► Subscribe
Warner Chilcott
AMITRIL
amitriptyline hydrochloride
TABLET;ORAL084957-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Warner Chilcott
CLORAZEPATE DIPOTASSIUM
clorazepate dipotassium
CAPSULE;ORAL071774-001Mar 1, 1988DISCNNoNo► Subscribe► Subscribe► Subscribe
Warner Chilcott
AMITRIL
amitriptyline hydrochloride
TABLET;ORAL083937-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Warner Chilcott
VICKS FORMULA 44
diphenhydramine hydrochloride
SYRUP;ORAL070524-001Jan 14, 1987DISCNNoNo► Subscribe► Subscribe► Subscribe
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Expired 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;ORAL021823-001Aug 12, 2005► Subscribe► Subscribe
Warner Chilcott
ACTONEL WITH CALCIUM (COPACKAGED)
calcium carbonate; risedronate sodium
TABLET, TABLET;ORAL021823-001Aug 12, 2005► Subscribe► Subscribe
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Paragraph IV activity for WARNER CHILCOTT drugs

Drugname Dosage Strength Tradename Submissiondate
doxycycline hyclate
Delayed-release Tablets50 mg
DORYX
11/5/2015
doxycycline hyclate
Delayed-release Tablets80 mg
DORYX
7/1/2015
doxycycline hyclate
Delayed-release Tablets200 mg
DORYX
5/19/2014
doxycycline hyclate (as of 6/10/14)
Delayed-release Tablets200 mg
DORYX
8/12/2013
doxycycline hyclate
Delayed-release Tablets150 mg
DORYX
12/19/2008

Non-Orange Book 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
6,225,294 Method for inhibiting bone resorption► Subscribe
6,569,460 Film-coated tablet for improved upper gastrointestinal tract safety► Subscribe
6,544,967 Method for inhibiting bone resorption► Subscribe
6,333,316 Method for inhibiting bone resorption► 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 Warner Chilcott Drugs

Country Document Number Estimated Expiration
China1602880► Subscribe
Japan5093937► Subscribe
Australia7446098► Subscribe
Canada2349744► Subscribe
Germany69803291► Subscribe
Austria209037► Subscribe
Serbia49979► Subscribe
United Kingdom9717850► Subscribe
Israel143264► Subscribe
Eurasian Patent Organization004544► 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 Warner Chilcott Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB02/037United Kingdom► SubscribePRODUCT 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
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
00125Netherlands► SubscribePRODUCT NAME: ROSUVASTATINUM, DESGEWENST IN DE VORM VAN EEN NIET-TOXISCH FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET CALCIUMZOUT; REGISTRATION NO/DATE: RVG 26872 - RVG 26874 20021106
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
2015000093Germany► SubscribePRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
2009 00017Denmark► SubscribePRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629
1214076/01Switzerland► SubscribePRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
222Luxembourg► Subscribe91222, EXPIRES: 20200824
2006002,C0998292Lithuania► SubscribePRODUCT NAME: NATRIUM ALENDRONICUM/COLECACIFEROLUM; REGISTRATION NO/DATE: EU/1/05/310/001, EU/1/05/310/002, EU/1/05/310/003, EU/1/05/310/004, EU/1/05/310/005 20050824
C/GB98/030United Kingdom► SubscribePRODUCT NAME: FOSPHENYTOIN SODIUM (3-HYDROXYMETHYL)-5,5-DIPHENYLHYDANTOIN DISODIUM PHOSPHATE ESTER); REGISTERED: UK 0019/0157 19980204
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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:

Daiichi Sankyo
Baxter
Cipla
Queensland Health
Mallinckrodt
Express Scripts
McKesson
Merck
Fuji
Covington

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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