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Serving 500+ biopharmaceutical companies globally:

Argus Health
Dow
Julphar
Mallinckrodt
Healthtrust
Chinese Patent Office
Teva
Novartis
Cipla
Covington

Generated: August 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 forty-nine 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.

Summary for Applicant: Lupin

Patents:5
Tradenames:117
Ingredients:100
NDAs:149
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lupin Ltd
POTASSIUM CHLORIDE
potassium chloride
CAPSULE, EXTENDED RELEASE;ORAL203002-002Dec 18, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe
Lupin Ltd
QUININE SULFATE
quinine sulfate
CAPSULE;ORAL203112-001Apr 24, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe
Lupin Ltd
LEVONORGESTREL AND ETHINYL ESTRADIOL
ethinyl estradiol; levonorgestrel
TABLET;ORAL-28091425-001Jan 18, 2013AB1RXNoNo► Subscribe► Subscribe► Subscribe
Lupin Pharms
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
amlodipine besylate; benazepril hydrochloride
CAPSULE;ORAL078466-004Feb 5, 2010ABRXNoNo► Subscribe► Subscribe► Subscribe
Lupin Ltd
ZOLPIDEM TARTRATE
zolpidem tartrate
TABLET, EXTENDED RELEASE;ORAL078970-002Sep 11, 2013ABRXNoNo► 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;ORAL021695-001Nov 30, 2004► Subscribe► Subscribe
Lupin Atlantis
ANTARA (MICRONIZED)
fenofibrate
CAPSULE;ORAL021695-002Nov 30, 2004► Subscribe► Subscribe
Lupin Atlantis
ANTARA (MICRONIZED)
fenofibrate
CAPSULE;ORAL021695-003Nov 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
9,241,905Pharmaceutical compositions of Cefixime► 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
World Intellectual Property Organization (WIPO)2005032526► Subscribe
Japan2003504331► Subscribe
Hong Kong1084895► Subscribe
Denmark1574214► Subscribe
South Korea101150235► 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
00499Netherlands► SubscribePRODUCT NAME: COMBINATIE OMVATTEND ALISKIREN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, EN AMLODIPINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/11/686/001-056 20110114
/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
/1998Austria► SubscribePRODUCT NAME: ''IRBESARTAN'' UND DESSEN PHARMAZEUTISCH ANNEHMBAREN SALZE; NAT. REGISTRATION NO/DATE: EU/1/97/046/001 - EU/1/97/046/009 19970827; FIRST REGISTRATION: LI 5425002 19970815
C0050France► SubscribePRODUCT NAME: VALSARTAN; REGISTRATION NO/DATE IN FRANCE: NL 22077 DU 19970321; REGISTRATION NO/DATE AT EEC: 369830000 DU 19960513
C0030France► SubscribePRODUCT NAME: EPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 32075 20060623; FIRST REGISTRATION: LI - 55783 01 20020607
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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 500+ biopharmaceutical companies globally:

McKinsey
Fuji
Cantor Fitzgerald
Novartis
Mallinckrodt
Federal Trade Commission
Citi
AstraZeneca
UBS
Teva

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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