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Serving leading biopharmaceutical companies globally:

Deloitte
McKinsey
Teva
Mallinckrodt
Novartis
US Department of Justice
Baxter
Johnson and Johnson
Covington
Medtronic

Generated: October 18, 2017

DrugPatentWatch Database Preview

Pregabalin - Generic Drug Details

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What are the generic sources for pregabalin and what is the scope of pregabalin patent protection?

Pregabalin
is the generic ingredient in one branded drug marketed by Pf Prism Cv and is included in two NDAs. There are three patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

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

There are thirty-seven drug master file entries for pregabalin. Twelve suppliers are listed for this compound. There are fifteen tentative approvals for this compound.

Summary for Generic Name: pregabalin

US Patents:3
Tradenames:1
Applicants:1
NDAs:2
Drug Master File Entries: see list37
Suppliers / Packagers: see list12
Bulk Api Vendors: see list63
Clinical Trials: see list358
Patent Applications: see list5,203
Therapeutic Class:Anticonvulsants
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:pregabalin at DailyMed

Tentative approvals for PREGABALIN

Applicant Application No. Strength Dosage Form
u► Subscribe25MGCAPSULE; ORAL
u► Subscribe300MGCAPSULE; ORAL
u► Subscribe225MGCAPSULE; ORAL
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
CAPSULE;ORAL021446-008Dec 30, 2004RXYesYes► Subscribe► Subscribe ► Subscribe
Pf Prism Cv
LYRICA
pregabalin
CAPSULE;ORAL021446-002Dec 30, 2004RXYesNo► Subscribe► Subscribe► Subscribe
Pf Prism Cv
LYRICA
pregabalin
CAPSULE;ORAL021446-002Dec 30, 2004RXYesNo► Subscribe► Subscribe ► Subscribe
Pf Prism Cv
LYRICA
pregabalin
CAPSULE;ORAL021446-003Dec 30, 2004RXYesNo► Subscribe► Subscribe► Subscribe
Pf Prism Cv
LYRICA
pregabalin
SOLUTION;ORAL022488-001Jan 4, 2010RXYesYes► Subscribe► SubscribeY ► Subscribe
Pf Prism Cv
LYRICA
pregabalin
CAPSULE;ORAL021446-004Dec 30, 2004RXYesNo► Subscribe► Subscribe► Subscribe
Pf Prism Cv
LYRICA
pregabalin
CAPSULE;ORAL021446-006Dec 30, 2004RXYesNo► Subscribe► SubscribeY ► Subscribe
Pf Prism Cv
LYRICA
pregabalin
CAPSULE;ORAL021446-004Dec 30, 2004RXYesNo► Subscribe► SubscribeYY ► Subscribe
Pf Prism Cv
LYRICA
pregabalin
CAPSULE;ORAL021446-003Dec 30, 2004RXYesNo► Subscribe► SubscribeYY ► Subscribe
Pf Prism Cv
LYRICA
pregabalin
CAPSULE;ORAL021446-002Dec 30, 2004RXYesNo► Subscribe► SubscribeY ► Subscribe
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Expired Orange Book Patents for Generic Ingredient: pregabalin

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
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
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;ORAL021446-004Dec 30, 2004► Subscribe► Subscribe
Pf Prism Cv
LYRICA
pregabalin
CAPSULE;ORAL021446-002Dec 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
CAPSULE;ORAL021446-003Dec 30, 2004► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: pregabalin

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
5,710,304 GABA and L-glutamic acid analogs for antiseizure treatment► Subscribe
6,414,024 GABA and L-glutamic acid analogs for antiseizure treatment► Subscribe
6,342,529 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
6,359,169 GABA and L-glutamic acid analogs for antiseizure treatment► Subscribe
6,140,366 GABA and L-glutamic acid analogs for antiseizure treatment► Subscribe
5,608,090 GABA and L-glutamic acid analogs for antiseizure treatment► Subscribe
6,525,096 GABA and L-glutamic acid analogs for antiseizure treatment► Subscribe
6,291,526 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 Ingredient: pregabalin

Country Document Number Estimated Expiration
JapanH07508288► Subscribe
Australia714980► Subscribe
Luxembourg91112► Subscribe
South Korea100491282► Subscribe
Norway990279► Subscribe
Australia9137091► Subscribe
Mexico9302970► Subscribe
Hong Kong1011022► Subscribe
Cuba22850► Subscribe
Germany69330949► 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: PREGABALIN

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
2004017,C0934061Lithuania► SubscribePRODUCT NAME: PREGABALINUM ((S)-3-(AMINOMETIL)-5-METILHEKSANO RUGSTIS); REGISTRATION NO/DATE: EU/1/04/279/001-025 20040725
0641330/01Switzerland► SubscribeFORMER REPRESENTANTIVE: E. BLUM AND CO. PATENTANWAELTE, CH
00164Netherlands► SubscribePRODUCT NAME: PREGABALINE, DESGEWENST IN DE; REGISTRATION NO/DATE: EU/1/04/279/001 20040706
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
112Luxembourg► Subscribe91112, EXPIRES: 20180518
2004017Lithuania► SubscribePRODUCT NAME: PREGABALINUM ((S)-3-(AMINOMETIL)-5-METILHEKSANO RûGðTIS)
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Moodys
Harvard Business School
US Army
McKinsey
Fish and Richardson
Cantor Fitzgerald
Merck
Chinese Patent Office
Boehringer Ingelheim
Fuji

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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