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Serving 500+ biopharmaceutical companies globally:

Merck
QuintilesIMS
Teva
AstraZeneca
Fuji
Argus Health
McKinsey
Boehringer Ingelheim
Chinese Patent Office
Farmers Insurance

Generated: September 26, 2017

DrugPatentWatch Database Preview

Lilly Company Profile

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

LILLY has one hundred and thirty approved drugs.

There are twenty-six US patents protecting LILLY drugs and there have been two Paragraph IV challenges on LILLY drugs in the past three years.

There are six hundred and thirty-three patent family members on LILLY drugs in sixty-five countries.

Summary for Applicant: Lilly

Patents:26
Tradenames:119
Ingredients:102
NDAs:130
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lilly
QUINIDINE SULFATE
quinidine sulfate
CAPSULE;ORAL085103-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Lilly
DIETHYLSTILBESTROL
diethylstilbestrol
TABLET, DELAYED RELEASE;ORAL004039-002Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Lilly
HUMULIN U
insulin zinc susp extended recombinant human
INJECTABLE;INJECTION019571-001Jun 10, 1987DISCNNoNo► Subscribe► Subscribe► Subscribe
Lilly
SYMBYAX
fluoxetine hydrochloride; olanzapine
CAPSULE;ORAL021520-004Dec 24, 2003ABRXYesNo► Subscribe► SubscribeYYY ► Subscribe
Lilly
ZYPREXA
olanzapine
INJECTABLE;INTRAMUSCULAR021253-001Mar 29, 2004APRXYesYes► Subscribe► Subscribe► Subscribe
Lilly
PROPYLTHIOURACIL
propylthiouracil
TABLET;ORAL006213-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Lilly
FORTEO
teriparatide recombinant human
INJECTABLE;SUBCUTANEOUS021318-001Nov 26, 2002DISCNNoNo► Subscribe► SubscribeY ► Subscribe
Lilly
KEFLIN
cephalothin sodium
INJECTABLE;INJECTION050482-003Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Lilly
FORTEO
teriparatide recombinant human
INJECTABLE;SUBCUTANEOUS021318-001Nov 26, 2002DISCNNoNo► Subscribe► SubscribeY ► Subscribe
Lilly
SYMBYAX
fluoxetine hydrochloride; olanzapine
CAPSULE;ORAL021520-004Dec 24, 2003ABRXYesNo► Subscribe► Subscribe ► Subscribe
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Expired Patents for Lilly

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Lilly
ZYPREXA ZYDIS
olanzapine
TABLET, ORALLY DISINTEGRATING;ORAL021086-003Apr 6, 2000► Subscribe► Subscribe
Lilly
ZYPREXA
olanzapine
TABLET;ORAL020592-002Sep 30, 1996► Subscribe► Subscribe
Lilly
ZYPREXA ZYDIS
olanzapine
TABLET, ORALLY DISINTEGRATING;ORAL021086-004Apr 6, 2000► Subscribe► Subscribe
Lilly
SYMBYAX
fluoxetine hydrochloride; olanzapine
CAPSULE;ORAL021520-004Dec 24, 2003► Subscribe► Subscribe
Lilly
HUMALOG MIX 50/50 KWIKPEN
insulin lispro protamine recombinant; insulin lispro recombinant
INJECTABLE;INJECTION021018-002Sep 6, 2007► Subscribe► Subscribe
Lilly
ZYPREXA
olanzapine
INJECTABLE;INTRAMUSCULAR021253-001Mar 29, 2004► Subscribe► Subscribe
Lilly
DECABID
indecainide hydrochloride
TABLET, EXTENDED RELEASE;ORAL019693-002Dec 29, 1989► Subscribe► Subscribe
Lilly
ZYPREXA
olanzapine
TABLET;ORAL020592-001Sep 30, 1996► Subscribe► Subscribe
Lilly
ZYPREXA
olanzapine
TABLET;ORAL020592-001Sep 30, 1996► Subscribe► Subscribe
Lilly
ZYPREXA
olanzapine
TABLET;ORAL020592-001Sep 30, 1996► Subscribe► Subscribe
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Paragraph IV activity for LILLY drugs

Drugname Dosage Strength Tradename Submissiondate
pemetrexed disodium
For Injection750 mg/vial
ALIMTA
10/6/2016
teriparatide
Injection250 mcg/mL, 2.4 mL prefilled Pen
FORTEO
7/27/2015
pemetrexed disodium
For Injection1000 mg/vial
ALIMTA
6/27/2012
duloxetine hydrochloride
Delayed-release Capsules40 mg
CYMBALTA
5/10/2012
tadalafil
Tablets2.5 mg
CIALIS
10/14/2008
duloxetine hydrochloride
Delayed-release Capsules20 mg, 30 mg and 60 mg
CYMBALTA
8/4/2008
pemetrexed disodium
For Injection100 mg/vial
ALIMTA
7/1/2008
olanzapine and fluoxetine hydrochloride
Capsules3 mg/25 mg
SYMBYAX
5/8/2008
pemetrexed disodium
For Injection500 mg/vial
ALIMTA
2/4/2008
tadalafil
Tablets5 mg, 10 mg and 20 mg
CIALIS
11/21/2007
gemcitabine
For Injection2 g/vial
GEMZAR
8/24/2007
atomoxetine hydrochloride
Capsules10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg and 100 mg
STRATTERA
5/29/2007
gemcitabine
For Injection1g/vial
GEMZAR
11/14/2005
gemcitabine
For Injection200 mg/vial
GEMZAR
11/1/2005
olanzapine and fluoxetine hydrochloride
Capsules6 mg/25 mg, 12 mg/25 mg, 6 mg/50 mg and 12 mg/50 mg
SYMBYAX
1/10/2005

Premature patent expirations for LILLY

Expiration due to failure to pay maintenance fee

Patent Number Expiration Date
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Non-Orange Book Patents for Lilly

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
7,857,791Medication dispensing apparatus with gear set having drive member accommodating opening► Subscribe
4,996,206 N-(pyrrolo[2,3-d]pyrimidin-3-ylacyl)-glutamic acid derivatives► Subscribe
6,369,059 Tetracyclic derivatives, process of preparation and use► Subscribe
6,608,065 Use of cGMP phosphodiesterase inhibitors in methods to treat female sexual dysfunction► Subscribe
6,143,746 Tetracyclic cyclic GMP-specific phosphodiesterase inhibitors, process of preparation and use► Subscribe
5,981,527 Cyclic GMP-specific phosphodiesterase inhibitors► Subscribe
6,841,167 .beta.-carboline pharmaceutical compositions► Subscribe
5,248,775 Pyrrolo(2,3-d)pyrimidines► Subscribe
6,025,494 Tetracyclic derivatives, process of preparation and use► Subscribe
7,427,275Medication dispensing apparatus with triple screw threads for mechanical advantage► 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 Lilly Drugs

Country Document Number Estimated Expiration
Canada2031890► Subscribe
Colombia5170493► Subscribe
European Patent Office1656170► Subscribe
South Korea100357411► Subscribe
Peru75399► Subscribe
Czech Republic9800032► Subscribe
Slovakia94096► Subscribe
Australia4490900► Subscribe
African Regional IP Organization (ARIPO)556► Subscribe
Argentina033639► 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 Lilly Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB95/010United Kingdom► SubscribePRODUCT NAME: 2-N-BUTYL-4-CHLORO-1-((2'-(1H-TETRAZOL-5-YL)BIPHENYL-4-YL) METHYL) -5-(HYDROXYMETHYL) IMIDAZOLE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN PARTICULAR A POTASSIUM SALT; REGISTERED: SE 12209 19940902; UK 0025/0324 19941215; UK 0025/0336 19941215
2209800/01Switzerland► SubscribePRODUCT NAME: INSULIN DEGLUDEC + LIRAGLUTIDE; REGISTRATION NO/DATE: SWISSMEDIC 65041 12.09.2014
00021Netherlands► SubscribePRODUCT NAME: INSULINE ASPART EN GEKRISTALLISEERD PROTAMINE-INSULINE ASPART; NAT. REGISTRATION NO/DATE: EU/1/00/142/001 20000801; FIRST REGISTRATION: 55414015541502 2000230623
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
C0020France► SubscribePRODUCT NAME: INSULIN DETEMIR; NAT. REGISTRATION NO/DATE: EU/1/04/278/001 20040601; FIRST REGISTRATION: LI - 56370 20031110
0722Netherlands► SubscribePRODUCT NAME: TOBRAMYCINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: C(2011)5394 20110720
/2000Austria► SubscribePRODUCT NAME: INSULIN ASPART/PROTAMIN; NAT. REGISTRATION NO/DATE: EU/1/00/142/001-008 20000801; FIRST REGISTRATION: LI 55414-55416 20000623
2013000061Germany► SubscribePRODUCT NAME: INSULIN DEGLUDEC IN ALLEN DURCH DAS BASISPATENT GESCHUETZTEN FORMEN; REGISTRATION NO/DATE: EU/1/12/807/001 EU/1/12/807/004-005 EU/1/12/807/007-009 EU/1/12/807/012-013 EU/1/12/807/015 20130121
147Luxembourg► Subscribe91147, EXPIRES: 20151210
00125Netherlands► SubscribePRODUCT NAME: ROSUVASTATINUM, DESGEWENST IN DE VORM VAN EEN NIET-TOXISCH FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET CALCIUMZOUT; REGISTRATION NO/DATE: RVG 26872 - RVG 26874 20021106
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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:

McKesson
Fish and Richardson
Medtronic
AstraZeneca
Queensland Health
Covington
Daiichi Sankyo
Cipla
Fuji
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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ISSN: 2162-2639

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