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Generated: September 22, 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.

Summary for Applicant: Warner Chilcott

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
CLONIDINE HYDROCHLORIDE
clonidine hydrochloride
TABLET;ORAL072138-001Jun 13, 1988DISCNNoNo► Subscribe► Subscribe► Subscribe
Warner Chilcott
ACTONEL WITH CALCIUM (COPACKAGED)
calcium carbonate; risedronate sodium
TABLET, TABLET;ORAL021823-001Aug 12, 2005DISCNYesNo► Subscribe► SubscribeY► Subscribe
Warner Chilcott
DIAZEPAM
diazepam
TABLET;ORAL070210-001Sep 4, 1985DISCNNoNo► Subscribe► Subscribe► Subscribe
Warner Chilcott
LABID
theophylline
TABLET, EXTENDED RELEASE;ORAL087225-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Warner Chilcott
AMITRIL
amitriptyline hydrochloride
TABLET;ORAL083937-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Warner Chilcott
DORYX
doxycycline hyclate
CAPSULE, DELAYED RELEASE;ORAL062653-001Oct 30, 1985DISCNNoNo► Subscribe► Subscribe► Subscribe
Warner Chilcott
DURICEF
cefadroxil/cefadroxil hemihydrate
FOR SUSPENSION;ORAL050527-003Approved Prior to Jan 1, 1982DISCNYesNo► Subscribe► Subscribe► Subscribe
Warner Chilcott
ERYPAR
erythromycin stearate
TABLET;ORAL062322-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Warner Chilcott
FUROSEMIDE
furosemide
TABLET;ORAL018419-002Jan 31, 1983DISCNNoNo► Subscribe► Subscribe► Subscribe
Warner Chilcott
ACTONEL WITH CALCIUM (COPACKAGED)
calcium carbonate; risedronate sodium
TABLET, TABLET;ORAL021823-001Aug 12, 2005DISCNYesNo► Subscribe► SubscribeY► 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
6,544,967 Method for inhibiting bone resorption► Subscribe
6,333,316 Method for inhibiting bone resorption► Subscribe
6,569,460 Film-coated tablet for improved upper gastrointestinal tract safety► 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
Malaysia118194► Subscribe
Germany01201911► Subscribe
Spain2253136► Subscribe
Argentina027158► Subscribe
Australia2451102► Subscribe
Japan2013067642► Subscribe
New Zealand503946► Subscribe
Russian Federation2193880► Subscribe
South Korea20030097611► Subscribe
New Zealand530113► 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
156Luxembourg► SubscribePRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
09/010Ireland► SubscribePRODUCT NAME: ALISKIREN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND HYDROCHLOROTHIAZIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; NAT REGISTRATION NO/DATE: EU/1/08/491/001-EU/1/08/491/080 20090116; FIRST REGISTRATION NO/DATE: 58935 01 58935 02 58935 03 58935 04 20081028
80045Netherlands► SubscribePRODUCT NAME: FOSPHENYTOINUM-DI-NATRICUM; NATL REGISTRATION NO/DATE: RVG 22758 19980702; FIRST REGISTRATION: GB PL 00019/0157 19980204
C0033France► SubscribePRODUCT NAME: ALISKIRENE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE E CELUI-CI, AMLODIPINE OU SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, ET HYDROCHLOROTHIAZIDE OU SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; NAT. REGISTRATION NO/DATE: EU/1/11/730/001 20111122; FIRST REGISTRATION: 6167801 20110705
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
2008006,C0933372Lithuania► SubscribePRODUCT NAME: FOSAMPRENAVIR CALCIUM; REGISTRATION NO/DATE: EU/1/04/282/001-002 20040712
00292Netherlands► SubscribePRODUCT NAME: ALENDRONINE ZUUR, BIJ VOORKEUR MET MONONATRIUMZOUT IN HET BIJZONDER HET MONONATRIUM TRIHYDRAATZOUT, EN COLECALCIFEROL, WAARIN 70MG ALENDRONINEZUUR AANWEZIG IS, GEBASSERD OP HET GEWICHT VAN ALENDRONINE; REGISTRATION NO/DATE: EU/1/05/310/001-005 20050824
2007007Lithuania► SubscribePRODUCT NAME: ACIDUM ALENDRONICUM NATRIUM, COLECALCIFEROLUM; REGISTRATION NO/DATE: EU/1/05/310/001 2005 08 24 EU/1/05/310/002 2005 08 24 EU/1/05/310/003 2005 08 24 EU/1/05/310/004 2005 08 24 EU/1/05/310/00 20050824
1214076/01Switzerland► SubscribePRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
2006 00005Denmark► Subscribe
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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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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Citi
Dow
US Army
Cantor Fitzgerald
Medtronic
UBS
Merck
Fish and Richardson
Harvard Business School
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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ISSN: 2162-2639

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