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Serving leading biopharmaceutical companies globally:

McKesson
Cantor Fitzgerald
Fish and Richardson
Queensland Health
US Department of Justice
Chubb
McKinsey
Baxter
Farmers Insurance
Cerilliant

Generated: December 16, 2017

DrugPatentWatch Database Preview

Lupin Company Profile

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

LUPIN has one hundred and fifty-eight approved drugs.

There are five US patents protecting LUPIN drugs on LUPIN drugs in the past three years. There are sixteen tentative approvals on LUPIN drugs.

There are eighty-five patent family members on LUPIN drugs in thirty-seven countries and two hundred and eleven supplementary protection certificates in thirteen countries.

Summary for Lupin

International Patents:85
US Patents:5
Tradenames:126
Ingredients:109
NDAs:158
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lupin LtdESZOPICLONEeszopicloneTABLET;ORAL091124-001Sep 13, 2011ABRXNoNo► Subscribe► Subscribe► Subscribe
Lupin LtdVALSARTAN AND HYDROCHLOROTHIAZIDEhydrochlorothiazide; valsartanTABLET;ORAL078946-004Mar 21, 2013ABRXNoNo► Subscribe► Subscribe► Subscribe
Lupin PharmsAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEamlodipine besylate; benazepril hydrochlorideCAPSULE;ORAL078466-006Jul 5, 2011ABRXNoNo► Subscribe► Subscribe► Subscribe
Lupin LtdIMIPRAMINE PAMOATEimipramine pamoateCAPSULE;ORAL090444-001Apr 16, 2010ABRXNoNo► Subscribe► Subscribe► Subscribe
Lupin LtdPERINDOPRIL ERBUMINEperindopril erbumineTABLET;ORAL078263-001Jan 27, 2010DISCNNoNo► Subscribe► Subscribe► Subscribe
Lupin PharmsMELOXICAMmeloxicamTABLET;ORAL077944-002Jul 19, 2006ABRXNoNo► Subscribe► Subscribe► Subscribe
Lupin LtdCLARITHROMYCINclarithromycinTABLET, EXTENDED RELEASE;ORAL202532-001Sep 15, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe
Lupin LtdZOLPIDEM TARTRATEzolpidem tartrateTABLET, EXTENDED RELEASE;ORAL078970-002Sep 11, 2013ABRXNoNo► Subscribe► Subscribe► Subscribe
LupinRAMIPRILramiprilCAPSULE;ORAL077626-004Jun 9, 2008ABRXNoNo► Subscribe► Subscribe► Subscribe
Lupin AtlantisTRIAMCINOLONE ACETONIDEtriamcinolone acetonideCREAM;TOPICAL208763-003Feb 1, 2017ATRXNoNo► Subscribe► Subscribe► Subscribe
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Expired Patents for Lupin

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Lupin AtlantisANTARA (MICRONIZED)fenofibrateCAPSULE;ORAL021695-001Nov 30, 2004► Subscribe► Subscribe
Lupin AtlantisANTARA (MICRONIZED)fenofibrateCAPSULE;ORAL021695-002Nov 30, 2004► Subscribe► Subscribe
Lupin AtlantisANTARA (MICRONIZED)fenofibrateCAPSULE;ORAL021695-003Nov 30, 2004► Subscribe► Subscribe
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Paragraph IV activity for LUPIN drugs

Drugname Dosage Strength Tradename Submissiondate
omeprazoleDelayed-release Tablets20 mgOMEPRAZOLE6/3/2015
cefiximefor Oral Suspension500 mg/5 mLSUPRAX7/22/2014

Non-Orange Book Patents for Lupin

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
9,241,905Pharmaceutical compositions of Cefixime► Subscribe
8,529,952Pharmaceutical composition containing fenofibrate and method for the preparation thereof► Subscribe
8,658,212Pharmaceutical composition containing fenofibrate and method for the preparation thereof► Subscribe
8,563,042Pharmaceutical composition containing fenofibrate and method for the preparation thereof► 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 Lupin Drugs

Country Document Number Estimated Expiration
Yugoslavia93201► Subscribe
Austria428408► Subscribe
Portugal1667666► Subscribe
Serbia50035► Subscribe
Spain2309438► Subscribe
Slovenia1194140► Subscribe
Israel147499► Subscribe
Portugal1574214► Subscribe
Slovenia1574214► Subscribe
China100544712► 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 Lupin Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
/2012Austria► SubscribePRODUCT NAME: KOMBINATIONSPRODUKT VON SAXAGLIPTIN UND METFORMIN UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON, BEINHALTEND DIE HYDROCHLORIDSALZE VON SAXAGLIPTIN UND METFORMIN; REGISTRATION NO/DATE: EU/1/11/731/001-EU/1/11/731/012 20111124
2006 00038Denmark► SubscribePRODUCT NAME: ETHINYLESTRADIOL (SOM BETA-CYCLODEXTRIN-CLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 38687 20060627; FIRST REG. NO/DATE: EU RVG 31781 20050804
0722Netherlands► SubscribePRODUCT NAME: TOBRAMYCINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: C(2011)5394 20110720
/1997Austria► SubscribePRODUCT NAME: ATORVASTATIN CALCIUM; NAT. REGISTRATION NO/DATE: 1-21926, 1-21927, 1-21928 19970411; FIRST REGISTRATION: GB PL 00018/0240 - PL 00018/0242 19961107
C0040France► SubscribePRODUCT NAME: EZETIMIBE; SIMVASTATINE; NAT. REGISTRATION NO/DATE: NL 31849 20050728; FIRST REGISTRATION: DE - 58 878 00 00 20040402
C/GB01/016United Kingdom► SubscribePRODUCT NAME: PIOGLITAZONE OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, ESPECIALLY THE HYDROCHLORIDE SALT; REGISTERED: CH IKS 55 378 01 20000927; CH IKS 55 378 02 20000927; CH IKS 55 378 03 20000927; UK EU/1/00/151/001 20001011; UK EU/1/00/151/002 20001011; UK EU/1/00/151/003 20001011; UK EU/1/00/151/004 20001011; UK EU/1/00/151/005 20001011; UK EU/1/00/151/006 20001011
C/GB95/028United Kingdom► SubscribePRODUCT NAME: TOPIRAMATE; REGISTERED: UK 0242/0301 19950718
330Luxembourg► SubscribeCERTIFICATE TITLE: UNE COMBINAISON D'OLMESARTAN MEDOXOMIL, OPTIONNELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE ET D'HYDROCHLOROTHIAZIDE (OLMETEC PLUS)
C/GB10/011United Kingdom► SubscribePRODUCT NAME: THE COMBINATION OF PIOGLITAZONE OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, ESPECIALLY THE HYDROCHLORIDE SALT, AND GLIMEPIRIDE.; REGISTERED: UK EU/1/06/366/001 20070108; UK EU/1/06/366/002 20070108; UK EU/1/06/366/003 20070108; UK EU/1/06/366/004 20070108; UK EU/1/06/366/005 20070108; UK EU/1/06/366/006 20070108; UK EU/1/06/366/019 20070108; UK EU/1/06/366/020 20070108; UK EU/1/06/366/021 20070108; UK EU/1/06/366/022 20070108; UK EU/1/06/366/013 20070108; UK EU/1/06/366/014 20070108; UK EU/1/06/366/015 20070108; UK EU/1/06/366/016 20070108; UK EU/1/06/366/017 20070108; UK EU/1/06/366/018 20070108; UK EU/1/06/366/007 20070108; UK EU/1/06/366/008 20070108; UK EU
2017 00030Denmark► SubscribePRODUCT NAME: IRINOTECAN SUCROSOFATE SALT, SUCH AS IRINOTECAN SUCROSOFATE SALT IN A PEGYLATED LIPOSOME, SUCH AS A LIPOSOME COMPRISING 1,2-DISTEAROYL-SN-PHOSPHATIDYLCHOLINE, CHOLESTEROL AND N-(OMEGA-METHOXY-POLY(ETHYLENE GLYCOL)...; REG. NO/DATE: EU/1 /16/1130 20161018
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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:

Express Scripts
Healthtrust
Dow
Moodys
Deloitte
Baxter
Federal Trade Commission
Fuji
Farmers Insurance
Johnson and Johnson

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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