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Serving 500+ biopharmaceutical companies globally:

QuintilesIMS
Deloitte
Medtronic
Julphar
Cerilliant
Express Scripts
Boehringer Ingelheim
Daiichi Sankyo
Farmers Insurance
Citi

Generated: September 24, 2017

DrugPatentWatch Database Preview

LYRICA Drug Profile

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What is the patent landscape for Lyrica, and when can generic versions of Lyrica launch?

Lyrica is a drug marketed by Pf Prism Cv and is included in two NDAs. There are three patents protecting this drug and two Paragraph IV challenges.

This drug has sixty-five patent family members in thirty-one countries.

The generic ingredient in LYRICA is pregabalin. There are thirty-seven drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the pregabalin profile page.

Summary for Tradename: LYRICA

Patents:3
Applicants:1
NDAs:2
Suppliers / Packagers: see list11
Bulk Api Vendors: see list62
Clinical Trials: see list72
Patent Applications: see list3,741
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:LYRICA at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pf Prism Cv
LYRICA
pregabalin
SOLUTION;ORAL022488-001Jan 4, 2010RXYesYes► Subscribe► SubscribeYY ► Subscribe
Pf Prism Cv
LYRICA
pregabalin
CAPSULE;ORAL021446-007Dec 30, 2004RXYesNo► Subscribe► Subscribe ► Subscribe
Pf Prism Cv
LYRICA
pregabalin
SOLUTION;ORAL022488-001Jan 4, 2010RXYesYes► Subscribe► Subscribe► Subscribe
Pf Prism Cv
LYRICA
pregabalin
CAPSULE;ORAL021446-006Dec 30, 2004RXYesNo► Subscribe► SubscribeY ► Subscribe
Pf Prism Cv
LYRICA
pregabalin
CAPSULE;ORAL021446-007Dec 30, 2004RXYesNo► Subscribe► SubscribeY ► Subscribe
Pf Prism Cv
LYRICA
pregabalin
CAPSULE;ORAL021446-001Dec 30, 2004RXYesNo► Subscribe► SubscribeYY ► Subscribe
Pf Prism Cv
LYRICA
pregabalin
CAPSULE;ORAL021446-004Dec 30, 2004RXYesNo► Subscribe► SubscribeY ► Subscribe
Pf Prism Cv
LYRICA
pregabalin
CAPSULE;ORAL021446-002Dec 30, 2004RXYesNo► Subscribe► Subscribe ► Subscribe
Pf Prism Cv
LYRICA
pregabalin
CAPSULE;ORAL021446-008Dec 30, 2004RXYesYes► Subscribe► SubscribeYY ► Subscribe
Pf Prism Cv
LYRICA
pregabalin
CAPSULE;ORAL021446-003Dec 30, 2004RXYesNo► Subscribe► Subscribe ► Subscribe
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Expired Patents for Tradename: LYRICA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pf Prism Cv
LYRICA
pregabalin
CAPSULE;ORAL021446-003Dec 30, 2004► Subscribe► Subscribe
Pf Prism Cv
LYRICA
pregabalin
CAPSULE;ORAL021446-004Dec 30, 2004► Subscribe► Subscribe
Pf Prism Cv
LYRICA
pregabalin
CAPSULE;ORAL021446-007Dec 30, 2004► Subscribe► Subscribe
Pf Prism Cv
LYRICA
pregabalin
CAPSULE;ORAL021446-001Dec 30, 2004► Subscribe► Subscribe
Pf Prism Cv
LYRICA
pregabalin
CAPSULE;ORAL021446-005Dec 30, 2004► Subscribe► Subscribe
Pf Prism Cv
LYRICA
pregabalin
CAPSULE;ORAL021446-008Dec 30, 2004► Subscribe► Subscribe
Pf Prism Cv
LYRICA
pregabalin
SOLUTION;ORAL022488-001Jan 4, 2010► Subscribe► Subscribe
Pf Prism Cv
LYRICA
pregabalin
CAPSULE;ORAL021446-006Dec 30, 2004► Subscribe► Subscribe
Pf Prism Cv
LYRICA
pregabalin
CAPSULE;ORAL021446-002Dec 30, 2004► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges for LYRICA

Drugname Dosage Strength RLD Submissiondate
pregabalinOral Solution20 mg/mLLyrica5/19/2010
pregabalinCapsules25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mgLyrica12/30/2008

Non-Orange Book Patents for Tradename: LYRICA

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
6,262,120 GABA and L-glutamic acid analogs for antiseizure treatment► Subscribe
6,291,526 GABA and L-glutamic acid analogs for antiseizure treatment► Subscribe
6,525,096 GABA and L-glutamic acid analogs for antiseizure treatment► Subscribe
5,563,175 GABA and L-glutamic acid analogs for antiseizure treatment► Subscribe
5,710,304 GABA and L-glutamic acid analogs for antiseizure treatment► Subscribe
5,684,189 GABA and L-glutamic acid analogs for antiseizure treatment► Subscribe
6,342,529 GABA and L-glutamic acid analogs for antiseizure treatment► Subscribe
5,608,090 GABA and L-glutamic acid analogs for antiseizure treatment► Subscribe
6,414,024 GABA and L-glutamic acid analogs for antiseizure treatment► Subscribe
6,255,345 GABA and L-glutamic acid analogs for antiseizure treatment► 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 Tradename: LYRICA

Country Document Number Estimated Expiration
Australia9137091► Subscribe
South Korea100491282► Subscribe
Japan4297814► Subscribe
Hungary9702482► Subscribe
South Africa9706562► Subscribe
Mexico9102241► Subscribe
China1094757► Subscribe
China1223574► Subscribe
Norway990279► Subscribe
Hungary9403310► 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 Tradename: LYRICA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
/2004Austria► SubscribePRODUCT NAME: PREGABALIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES; REGISTRATION NO/DATE: EU/1/04/279/001 - EU/1/04/279/025 20040706
04C/022Belgium► SubscribePRODUCT NAME: PREGABALIN; REGISTRATION NO/DATE: EU/1/04/279/001 20040708
0164Netherlands► Subscribe300164, 20130518, EXPIRES: 20180517
2004 00036Denmark► Subscribe
2004017,C0934061Lithuania► SubscribePRODUCT NAME: PREGABALINUM ((S)-3-(AMINOMETIL)-5-METILHEKSANO RUGSTIS); REGISTRATION NO/DATE: EU/1/04/279/001-025 20040725
C/GB04/034United Kingdom► SubscribePRODUCT NAME: PREGABALIN (S-(+)-4-AMINO-3(2-METHYLPROPYL)BUTANOIC ACID) OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACTIVE SALT.; REGISTERED: UK EU/1/04/279/001 20040706; UK EU/1/04/279/002 20040706; UK EU/1/04/279/003 20040706; UK EU/1/04/279/004 20040706; UK EU/1/04/279/005 20040706; UK EU/1/04/279/006 20040706; UK EU/1/04/279/025 20040706; UK EU/1/04/279/019 20040706; UK EU/1/04/279/020 20040706; UK EU/1/04/279/021 20040706; UK EU/1/04/279/022 20040706; UK EU/1/04/279/023 20040706; UK EU/1/04/279/024 20040706; UK EU/1/04/279/013 20040706; UK EU/1/04/279/014 20040706; UK EU/1/04/279/015 20040706; UK EU/1/04/279/016 20040706; UK EU/1/04/279/017 20040706; UK EU/1/04/279/018 20040706; UK EU/
2004017Lithuania► SubscribePRODUCT NAME: PREGABALINUM ((S)-3-(AMINOMETIL)-5-METILHEKSANO RûGðTIS)
0641330/01Switzerland► SubscribeFORMER REPRESENTANTIVE: E. BLUM AND CO. PATENTANWAELTE, CH
C016/2004Ireland► SubscribeSPC016/2004: 20050803, EXPIRES: 20180517
112Luxembourg► Subscribe91112, EXPIRES: 20180518
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Farmers Insurance
Moodys
US Army
Fuji
Harvard Business School
Merck
UBS
Julphar
Citi
QuintilesIMS

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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