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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
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AstraZeneca
Baxter
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Express Scripts
Chinese Patent Office
Covington
Federal Trade Commission
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Generated: December 14, 2017

DrugPatentWatch Database Preview

LYRICA Drug Profile

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When do Lyrica patents expire, and when can generic versions of Lyrica launch?

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

This drug has sixty-eight patent family members in thirty-one countries and twelve supplementary protection certificates in nine 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.

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Pf Prism CvLYRICApregabalinSOLUTION;ORAL022488-001Jan 4, 2010RXYesYes► Subscribe► Subscribe► SubscribeYY► Subscribe
Pf Prism CvLYRICApregabalinCAPSULE;ORAL021446-007Dec 30, 2004RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Pfizer IncLYRICA CRpregabalinTABLET, EXTENDED RELEASE;ORAL209501-003Oct 11, 2017RXYesYes► Subscribe► Subscribe► SubscribeYY► Subscribe
Pf Prism CvLYRICApregabalinSOLUTION;ORAL022488-001Jan 4, 2010RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Pfizer IncLYRICA CRpregabalinTABLET, EXTENDED RELEASE;ORAL209501-001Oct 11, 2017RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Pfizer IncLYRICA CRpregabalinTABLET, EXTENDED RELEASE;ORAL209501-002Oct 11, 2017RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Pfizer IncLYRICA CRpregabalinTABLET, EXTENDED RELEASE;ORAL209501-003Oct 11, 2017RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Pf Prism CvLYRICApregabalinCAPSULE;ORAL021446-006Dec 30, 2004RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Pf Prism CvLYRICApregabalinCAPSULE;ORAL021446-007Dec 30, 2004RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Pf Prism CvLYRICApregabalinCAPSULE;ORAL021446-001Dec 30, 2004RXYesNo► Subscribe► Subscribe► SubscribeYY► Subscribe
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Expired Patents for Tradename: LYRICA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pf Prism CvLYRICApregabalinCAPSULE;ORAL021446-005Dec 30, 2004► Subscribe► Subscribe
Pf Prism CvLYRICApregabalinCAPSULE;ORAL021446-008Dec 30, 2004► Subscribe► Subscribe
Pf Prism CvLYRICApregabalinCAPSULE;ORAL021446-001Dec 30, 2004► Subscribe► Subscribe
Pf Prism CvLYRICApregabalinSOLUTION;ORAL022488-001Jan 4, 2010► Subscribe► Subscribe
Pf Prism CvLYRICApregabalinCAPSULE;ORAL021446-002Dec 30, 2004► Subscribe► Subscribe
Pf Prism CvLYRICApregabalinCAPSULE;ORAL021446-006Dec 30, 2004► Subscribe► Subscribe
Pf Prism CvLYRICApregabalinCAPSULE;ORAL021446-003Dec 30, 2004► Subscribe► Subscribe
Pf Prism CvLYRICApregabalinCAPSULE;ORAL021446-004Dec 30, 2004► Subscribe► Subscribe
Pf Prism CvLYRICApregabalinCAPSULE;ORAL021446-007Dec 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
6,028,214 GABA and L-glutamic acid analogs for antiseizure treatment► Subscribe
6,414,024 GABA and L-glutamic acid analogs for antiseizure treatment► Subscribe
6,291,526 GABA and L-glutamic acid analogs for antiseizure treatment► Subscribe
5,563,175 GABA and L-glutamic acid analogs for antiseizure treatment► Subscribe
6,117,906 GABA and L-glutamic acid analogs for antiseizure treatment► Subscribe
6,342,529 GABA and L-glutamic acid analogs for antiseizure treatment► Subscribe
6,140,366 GABA and L-glutamic acid analogs for antiseizure treatment► Subscribe
5,847,151 Gaba and L-glutamic acid analogs for antiseizure treatment► Subscribe
5,684,189 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
World Intellectual Property Organization (WIPO)9209560► Subscribe
World Intellectual Property Organization (WIPO)9323383► Subscribe
HungaryT71522► Subscribe
Spain2200184► Subscribe
Norway990279► Subscribe
Mexico9302970► Subscribe
Germany122004000039► Subscribe
Denmark0934061► Subscribe
Norway325822► Subscribe
Japan2004238398► 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
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/
2004 00036Denmark► Subscribe
04C/022Belgium► SubscribePRODUCT NAME: PREGABALIN; REGISTRATION NO/DATE: EU/1/04/279/001 20040708
00164Netherlands► SubscribePRODUCT NAME: PREGABALINE, DESGEWENST IN DE; REGISTRATION NO/DATE: EU/1/04/279/001 20040706
C016/2004Ireland► SubscribeSPC016/2004: 20050803, EXPIRES: 20180517
0641330/01Switzerland► SubscribeFORMER REPRESENTANTIVE: E. BLUM AND CO. PATENTANWAELTE, CH
2004 00036Denmark► SubscribePRODUCT NAME: PREGABALIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/04/279/001-025 20040706
0164Netherlands► Subscribe300164, 20130518, EXPIRES: 20180517
/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
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Serving leading biopharmaceutical companies globally:

Moodys
US Army
Daiichi Sankyo
Express Scripts
AstraZeneca
Fish and Richardson
Mallinckrodt
Covington
Queensland Health
Deloitte

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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