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Serving leading biopharmaceutical companies globally:

Baxter
QuintilesIMS
Chinese Patent Office
Cerilliant
Covington
Mallinckrodt
Citi
Julphar
Johnson and Johnson
Fuji

Generated: November 19, 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-five patent family members on LILLY drugs in sixty-five countries and ninety-eight supplementary protection certificates in twelve countries.

Summary for Lilly

International Patents:635
US 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
CIALIS
tadalafil
TABLET;ORAL021368-002Nov 21, 2003RXYesNo► Subscribe► Subscribe ► Subscribe
Lilly
MANDOL
cefamandole nafate
INJECTABLE;INJECTION062560-002Sep 10, 1985DISCNNoNo► Subscribe► Subscribe► Subscribe
Lilly
HUMALOG MIX 75/25 PEN
insulin lispro protamine recombinant; insulin lispro recombinant
INJECTABLE;INJECTION021017-003Dec 22, 1999DISCNNoNo► Subscribe► Subscribe► Subscribe
Lilly
ILOSONE
erythromycin estolate
CAPSULE;ORAL061897-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Lilly
CECLOR
cefaclor
CAPSULE;ORAL050521-001Approved Prior to Jan 1, 1982DISCNYesNo► Subscribe► Subscribe► Subscribe
Lilly
SYMBYAX
fluoxetine hydrochloride; olanzapine
CAPSULE;ORAL021520-003Dec 24, 2003ABRXYesYes► Subscribe► SubscribeYYY ► Subscribe
Lilly
PROZAC
fluoxetine hydrochloride
TABLET;ORAL020974-001Mar 9, 1999DISCNYesNo► Subscribe► Subscribe► Subscribe
Lilly
CIALIS
tadalafil
TABLET;ORAL021368-002Nov 21, 2003RXYesNo► Subscribe► SubscribeY ► Subscribe
Lilly
NEBCIN
tobramycin sulfate
INJECTABLE;INJECTION062707-001Apr 29, 1987DISCNNoNo► Subscribe► Subscribe► Subscribe
Lilly
CIALIS
tadalafil
TABLET;ORAL021368-003Nov 21, 2003RXYesYes► Subscribe► SubscribeYY ► Subscribe
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Expired Patents for Lilly

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Lilly
GEMZAR
gemcitabine hydrochloride
INJECTABLE;INJECTION020509-002May 15, 1996► Subscribe► Subscribe
Lilly
ZYPREXA ZYDIS
olanzapine
TABLET, ORALLY DISINTEGRATING;ORAL021086-003Apr 6, 2000► Subscribe► Subscribe
Lilly
SYMBYAX
fluoxetine hydrochloride; olanzapine
CAPSULE;ORAL021520-001Apr 9, 2007► Subscribe► Subscribe
Lilly
EVISTA
raloxifene hydrochloride
TABLET;ORAL020815-001Dec 9, 1997► Subscribe► Subscribe
Lilly
ZYPREXA ZYDIS
olanzapine
TABLET, ORALLY DISINTEGRATING;ORAL021086-003Apr 6, 2000► Subscribe► Subscribe
Lilly
EVISTA
raloxifene hydrochloride
TABLET;ORAL020815-001Dec 9, 1997► Subscribe► Subscribe
Lilly
HUMALOG MIX 75/25
insulin lispro protamine recombinant; insulin lispro recombinant
INJECTABLE;INJECTION021017-001Dec 22, 1999► Subscribe► Subscribe
Lilly
EVISTA
raloxifene hydrochloride
TABLET;ORAL020815-001Dec 9, 1997► Subscribe► Subscribe
Lilly
ALIMTA
pemetrexed disodium
INJECTABLE;IV (INFUSION)021462-001Feb 4, 2004► Subscribe► Subscribe
Lilly
HALDRONE
paramethasone acetate
TABLET;ORAL012772-006Approved Prior to Jan 1, 1982► 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
6,143,746 Tetracyclic cyclic GMP-specific phosphodiesterase inhibitors, process of preparation and use► Subscribe
6,841,167 .beta.-carboline pharmaceutical compositions► Subscribe
4,996,206 N-(pyrrolo[2,3-d]pyrimidin-3-ylacyl)-glutamic acid derivatives► Subscribe
5,981,527 Cyclic GMP-specific phosphodiesterase inhibitors► Subscribe
6,784,179 Tetracyclic derivatives, process of preparation and use► Subscribe
7,857,791Medication dispensing apparatus with gear set having drive member accommodating opening► Subscribe
7,427,275Medication dispensing apparatus with triple screw threads for mechanical advantage► Subscribe
6,127,542 Tetracyclic derivatives, process of preparation and use► Subscribe
5,248,775 Pyrrolo(2,3-d)pyrimidines► Subscribe
6,369,059 Tetracyclic derivatives, process of preparation and use► 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
Australia2005231731► Subscribe
Hungary230697► Subscribe
JapanH10330253► Subscribe
Spain2190244► Subscribe
Australia6904898► Subscribe
Indonesia29039► Subscribe
Australia689205► Subscribe
Ukraine72205► Subscribe
Japan2016106159► Subscribe
Eurasian Patent Organization200000629► 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/GB05/003United Kingdom► SubscribePRODUCT NAME: DULOXETINE AND PHARMACUETICALLY ACCEPTABLE ACID ADDITION SALTS THEREOF, AND IN PARTICULAR DULOXETINE HYDROCHLORIDE; REGISTERED: UK EU/1/04/280/001 20040811; UK EU/1/04/280/002 20040811; UK EU/1/04/280/003 20040811; UK EU/1/04/280/004 20040811; UK EU/1/04/280/005 20040811; UK EU/1/04/280/006 20040811
0596Netherlands► SubscribePRODUCT NAME: INSULINE DEGLUDEC; NATIONAL REGISTRATION NO/DATE: EU/1/12/807/004 20130123; FIRST REGISTRATION: EU EU/1/12/807/001 20130123
2/2005Austria► SubscribePRODUCT NAME: INSULIN GLULISINE
678Luxembourg► SubscribePRODUCT NAME: TOBRAMYCINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE QUI EN DERIVE. FIRST REGISTRATION: 20110725
2017 00013Denmark► SubscribePRODUCT NAME: KOMBINATION AF INSULIN DEGLUDEC OG LIRAGLUTID; NAT. REG. NO/DATE: EU/1/14/947 20140922; FIRST REG. NO/DATE: CH 65041 20140912
C0035France► SubscribePRODUCT NAME: INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/12/807/001 20130121
05C/001Belgium► SubscribePRODUCT NAME: CHLORHYDRATE DE DULOXETINE; REGISTRATION NO/DATE: EU/1/04/280/001 20040811
C/GB98/048United Kingdom► SubscribePRODUCT NAME: RALOXIFENE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/98/073/001 19980805; UK EU/1/98/073/002 19980805; UK EU/1/98/073/003 19980805; UK EU/1/98/073/004 19980805; UK EU/1/98/074/001 19980805; UK EU/1/98/074/002 19980805; UK EU/1/98/074/003 19980805; UK EU/1/98/074/004 19980805
0813Netherlands► SubscribePRODUCT NAME: AMBRISENTAN TOEGEPAST IN COMBINATIEBEHANDELING MET TADALAFIL; REGISTRATION NO/DATE: EU/1/08/451 (C(2008) 1637) 20151125
C0030Belgium► SubscribePRODUCT NAME: CHLORHYDRATE DE GEMCITABINE EQUIVALENT EN GEMCITABINE; NAT. REGISTRATION NO/DATE: 58 IS 88 F 12 19960606; FIRST REGISTRATION: NL RVG 17854 19950327
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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:

Novartis
QuintilesIMS
Daiichi Sankyo
McKinsey
Medtronic
Federal Trade Commission
Cerilliant
Harvard Business School
Dow
Julphar

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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