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Generated: July 22, 2017
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.| 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 | DURICEF | cefadroxil/cefadroxil hemihydrate | CAPSULE;ORAL | 050512-001 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ► Subscribe | ► Subscribe | |||||||||||||||||||
Warner Chilcott | AMITRIL | amitriptyline hydrochloride | TABLET;ORAL | 083937-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ► Subscribe | ► Subscribe | |||||||||||||||||||
Warner Chilcott | CYANOCOBALAMIN | cyanocobalamin | INJECTABLE;INJECTION | 007085-002 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ► Subscribe | ► Subscribe | |||||||||||||||||||
Warner Chilcott | CLORAZEPATE DIPOTASSIUM | clorazepate dipotassium | TABLET;ORAL | 071829-001 | Mar 3, 1988 | DISCN | No | No | ► Subscribe | ► Subscribe | |||||||||||||||||||
Warner Chilcott | PROPRANOLOL HYDROCHLORIDE | propranolol hydrochloride | TABLET;ORAL | 070441-001 | Sep 24, 1986 | DISCN | No | No | ► Subscribe | ► Subscribe | |||||||||||||||||||
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| 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 | ► Subscribe | ||||||||||||||||||||||
Warner Chilcott | ACTONEL WITH CALCIUM (COPACKAGED) | calcium carbonate; risedronate sodium | TABLET, TABLET;ORAL | 021823-001 | Aug 12, 2005 | 6,096,342*PED | ► Subscribe | ||||||||||||||||||||||
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| Drugname | Dosage | Strength | Tradename | Submissiondate |
|---|---|---|---|---|
doxycycline hyclate | Delayed-release Tablets | 50 mg | DORYX | 11/5/2015 |
doxycycline hyclate | Delayed-release Tablets | 80 mg | DORYX | 7/1/2015 |
doxycycline hyclate | Delayed-release Tablets | 200 mg | DORYX | 5/19/2014 |
doxycycline hyclate (as of 6/10/14) | Delayed-release Tablets | 200 mg | DORYX | 8/12/2013 |
doxycycline hyclate | Delayed-release Tablets | 150 mg | DORYX | 12/19/2008 |
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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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| World Intellectual Property Organization (WIPO) | 9904773 | ► Subscribe | |||||||||||||||||||||||||||
| Australia | 7446098 | ► Subscribe | |||||||||||||||||||||||||||
| Australia | 6406900 | ► Subscribe | |||||||||||||||||||||||||||
| European Patent Office | 0989848 | ► Subscribe | |||||||||||||||||||||||||||
| European Patent Office | 1175903 | ► 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 Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C/GB98/031 | United Kingdom | ► Subscribe | PRODUCT NAME: 2-BUTYL-4-CHLORO-1-((2'-(1H-TETRAZOL-5-YL) BIPHENYL-4-YL)-METHYL)-5-(HYDROXYMETHYL)IMIDAZOLE (LOSARTAN),OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN PARTICULAR A POTASSIUM SALT( LOSARTAN POTASSIUM) AND HYDROCHLOROTHIAZIDE,; REGISTERED: FR 338520.7 19950215; FR 558453.7 19950215; UK 00025/0338 19960412 | ||||||||||||||||||||||||||
| 13/055 | Ireland | ► Subscribe | 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 | ||||||||||||||||||||||||||
| 2006 00038 | Denmark | ► Subscribe | PRODUCT NAME: ETHINYLESTRADIOL (SOM BETA-CYCLODEXTRIN-CLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 38687 20060627; FIRST REG. NO/DATE: EU RVG 31781 20050804 | ||||||||||||||||||||||||||
| 1214076/01 | Switzerland | ► Subscribe | PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008 | ||||||||||||||||||||||||||
| 2009 00017 | Denmark | ► Subscribe | PRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629 | ||||||||||||||||||||||||||
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Serving 500+ biopharmaceutical companies globally:
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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