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Serving 500+ biopharmaceutical companies globally:

Cantor Fitzgerald
Deloitte
Chubb
McKinsey
Boehringer Ingelheim
Harvard Business School
Merck
Medtronic
Moodys
Dow

Generated: July 27, 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-one 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
METHYLTESTOSTERONE
methyltestosterone
TABLET;BUCCAL, SUBLINGUAL080256-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Lilly
FORTEO
teriparatide recombinant human
INJECTABLE;SUBCUTANEOUS021318-002Jun 25, 2008RXYesYes► Subscribe► SubscribeY ► Subscribe
Lilly
CIALIS
tadalafil
TABLET;ORAL021368-003Nov 21, 2003RXYesYes► Subscribe► SubscribeYY ► Subscribe
Lilly
PROZAC WEEKLY
fluoxetine hydrochloride
CAPSULE, DELAYED REL PELLETS;ORAL021235-001Feb 26, 2001ABRXYesYes► Subscribe► SubscribeY► Subscribe
Lilly
CIALIS
tadalafil
TABLET;ORAL021368-001Nov 21, 2003RXYesNo► Subscribe► SubscribeYY ► Subscribe
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Expired Patents for Lilly

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Lilly
EVISTA
raloxifene hydrochloride
TABLET;ORAL020815-001Dec 9, 1997► Subscribe► Subscribe
Lilly
ZYPREXA
olanzapine
TABLET;ORAL020592-001Sep 30, 1996► Subscribe► Subscribe
Lilly
ZYPREXA ZYDIS
olanzapine
TABLET, ORALLY DISINTEGRATING;ORAL021086-004Apr 6, 2000► Subscribe► Subscribe
Lilly
SYMBYAX
fluoxetine hydrochloride; olanzapine
CAPSULE;ORAL021520-005Dec 24, 2003► Subscribe► Subscribe
Lilly
ZYPREXA
olanzapine
TABLET;ORAL020592-006Sep 9, 1997► 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
6,127,542 Tetracyclic derivatives, process of preparation and use► Subscribe
7,857,791Medication dispensing apparatus with gear set having drive member accommodating opening► Subscribe
6,451,807 Methods of treating sexual dysfunction in an individual suffering from a retinal disease, class 1 congestive heart failure, or myocardial infarction using a PDE5 inhibitor► Subscribe
4,996,206 N-(pyrrolo[2,3-d]pyrimidin-3-ylacyl)-glutamic acid derivatives► Subscribe
6,841,167 .beta.-carboline pharmaceutical compositions► 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
Singapore98384► Subscribe
South Africa9811127► Subscribe
World Intellectual Property Organization (WIPO)9703985► Subscribe
China1311828► Subscribe
Hungary0300477► 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
00597Netherlands► SubscribePRODUCT NAME: INSULINE DEGLUDEC EN INSULINE ASPART; REGISTRATION NO/DATE: EU/1/12/806/001EU/1/12/806/004EU/1/12/806/005EU/1/12/806/007EU/1/12/806/008 2013210121
C0012Belgium► SubscribePRODUCT NAME: OLANZAPINE; REGISTRATION NO/DATE: EU/1/96/022/001 19960927
2005Austria► SubscribePRODUCT NAME: PEMETREXED UND DESSEN PHARMAZEUTISCH ANNAHMBAREN SALZE; REGISTRATION NO/DATE: EU/1/04/290/001 20040920
081Luxembourg► SubscribePRODUCT NAME: AMBRISENTAN UTILISE EN TRAITEMENT COMBINE AVEC TADALAFIL; FRIST REGISTRATION: 20151125
0181Netherlands► Subscribe300181, 20101210, EXPIRES: 20151209
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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:

Citi
Cerilliant
Chubb
Accenture
Boehringer Ingelheim
Julphar
QuintilesIMS
Cipla
McKesson
Moodys

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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