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Serving leading biopharmaceutical companies globally:

McKinsey
Medtronic
Julphar
Harvard Business School
Covington
Express Scripts
Daiichi Sankyo
Teva
Federal Trade Commission
Argus Health

Generated: October 20, 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-five 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 eight supplementary protection certificates in thirteen countries.

Summary for Applicant: Lupin

International Patents:85
US Patents:5
Tradenames:123
Ingredients:106
NDAs:155
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lupin Ltd
SUPRAX
cefixime
CAPSULE;ORAL203195-001Jun 1, 2012RXYesYes► Subscribe► Subscribe► Subscribe
Lupin Ltd
NADOLOL
nadolol
TABLET;ORAL209309-003Oct 5, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Lupin
CARVEDILOL
carvedilol
TABLET;ORAL078217-003Sep 5, 2007ABRXNoNo► Subscribe► Subscribe► Subscribe
Lupin Atlantis
ANTARA (MICRONIZED)
fenofibrate
CAPSULE;ORAL021695-003Nov 30, 2004ABRXYesYes► Subscribe► SubscribeYY ► Subscribe
Lupin Ltd
LEVONORGESTREL AND ETHINYL ESTRADIOL
ethinyl estradiol; levonorgestrel
TABLET;ORAL091674-001Oct 26, 2011ABRXNoNo► Subscribe► Subscribe► Subscribe
Lupin Ltd
RANOLAZINE
ranolazine
TABLET, EXTENDED RELEASE;ORAL201046-001Jul 29, 2013DISCNNoNo► Subscribe► Subscribe► Subscribe
Lupin Ltd
VANCOMYCIN HYDROCHLORIDE
vancomycin hydrochloride
CAPSULE;ORAL090439-001Jan 28, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe
Lupin Ltd
FALLBACK SOLO
levonorgestrel
TABLET;ORAL201446-001Jun 19, 2014OTCNoNo► Subscribe► Subscribe► Subscribe
Lupin Ltd
TRAMADOL HYDROCHLORIDE
tramadol hydrochloride
TABLET, EXTENDED RELEASE;ORAL200503-001Aug 29, 2011AB1RXNoYes► Subscribe► Subscribe► Subscribe
Lupin Ltd
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE
amlodipine besylate; hydrochlorothiazide; valsartan
TABLET;ORAL200797-001Jun 3, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe
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Expired Patents for Lupin

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

Drugname Dosage Strength Tradename Submissiondate
omeprazole
Delayed-release Tablets20 mg
OMEPRAZOLE
6/3/2015
cefixime
for Oral Suspension500 mg/5 mL
SUPRAX
7/22/2014

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
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
9,241,905Pharmaceutical compositions of Cefixime► 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
New Zealand546692► Subscribe
Austria291912► Subscribe
World Intellectual Property Organization (WIPO)2014091318► Subscribe
France2795961► Subscribe
Bulgaria65504► Subscribe
Australia2004277757► Subscribe
China1360499► Subscribe
Hungary229044► Subscribe
Spain2235919► Subscribe
Denmark1574214► 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
2008006,C0933372Lithuania► SubscribePRODUCT NAME: FOSAMPRENAVIR CALCIUM; REGISTRATION NO/DATE: EU/1/04/282/001-002 20040712
C/GB97/086United Kingdom► SubscribePRODUCT NAME: QUETIAPINE OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY-ACCEPTABLE SALT; REGISTERED: UK 12619/0112 19970731; UK 12619/0113 19970731; UK 12619/0114 19970731
00172Netherlands► SubscribePRODUCT NAME: EZETIMIBE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN SIMVASTATINE; NAT. REGISTRATION NO/DATE: RVG 30927RVG 30928RVG 30929RVG 30930 2004221122; FIRST REGISTRATION: 58874.00.0058874.01.0058874.02.0058874.03.0058878.00.0058878.01.0058878.02.0058878.03.0058866.00.0058866.01.0058866.02.0058866.03.0058870.00.0058870.01.0058870.02.0058870.03.00 2004020402
0811Netherlands► SubscribePRODUCT NAME: SACUBITRIL/VALSARTAN, MET INBEGRIP VAN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/15/1058 (C(2015) 8288) 20151123
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
C/GB11/010United Kingdom► SubscribePRODUCT NAME: THE COMBINATION OF A) TELMISARTAN, OPTIONALLY IN THE FORM OF PHARMACEUTICALLY ACCEPTABLE SALTS, AND B) AMLODIPINE, OPTIONALLY IN THE FORM OF PHARMACEUTICALLY ACCEPTABLE SALTS, ESPECIALLY AMLODIPINE BESYLATE; REGISTERED: UK EU/1/10/648/001 20101007; UK EU/1/10/648/002 20101007; UK EU/1/10/648/003 20101007; UK EU/1/10/648/004 20101007; UK EU/1/10/648/005 20101007; UK EU/1/10/648/006 20101007; UK EU/1/10/648/007 20101007; UK EU/1/10/648/008 20101007; UK EU/1/10/648/009 20101007; UK EU/1/10/648/010 20101007; UK EU/1/10/648/011 20101007; UK EU/1/10/648/012 20101007; UK EU/1/10/648/013 20101007; UK EU/1/10/648/014 20101007; UK EU/1/10/648/015 20101007; UK EU/1/10/648/016 20101007; UK
2009 00017Denmark► SubscribePRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629
2008000046Germany► SubscribePRODUCT NAME: SITAGLIPTIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE SITAGLIPTINPHOSPHAT- MONOHYDRAT, IN KOMBINATION MIT METFORMIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE DES HYDROCHLORIDS; NAT. REGISTRATION NO/DATE: EU/1/08/455/001-014 20080716 FIRST REGISTRATION: CH/LI 58450 01 58450 02 58450 03 20080408
C0048France► SubscribePRODUCT NAME: AMLODIPINE OU UN DE SES SELS D?ADDITION D?ACIDES PHARMACAUTIQUEMENT ACCEPTABLES/ ATORVASTATINE OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE IN FRANCE: NL 29929 DU 20050707; REGISTRATION NO/DATE AT EEC: NL 29929 DU 20050707
C0009Belgium► SubscribePRODUCT NAME: COLFOSCERIL PALMITAS (DIPALMITOYLPHOSPHATIDYLCHOLINE) (DPPC); NAT REG.: 251 IS 142 F 12; FIRST REG.: GB PL 0003/0283 19901214
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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 leading biopharmaceutical companies globally:

Chinese Patent Office
Accenture
McKinsey
Mallinckrodt
Citi
Cerilliant
Merck
Boehringer Ingelheim
Farmers Insurance
Chubb

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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