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Serving leading biopharmaceutical companies globally:

Chubb
Boehringer Ingelheim
Johnson and Johnson
Mallinckrodt
US Department of Justice
Cipla
Citi
Medtronic
Express Scripts
Teva

Generated: November 19, 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. Eleven suppliers are listed for this compound. There are fifteen tentative approvals for this compound.

Medical Subject Heading (MeSH) Categories for pregabalin

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;ORAL021446-005Dec 30, 2004RXYesNo► Subscribe► SubscribeY ► Subscribe
Pf Prism Cv
LYRICA
pregabalin
CAPSULE;ORAL021446-001Dec 30, 2004RXYesNo► Subscribe► SubscribeYY ► Subscribe
Pf Prism Cv
LYRICA
pregabalin
SOLUTION;ORAL022488-001Jan 4, 2010RXYesYes► 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;ORAL021446-005Dec 30, 2004RXYesNo► Subscribe► SubscribeYY ► Subscribe
Pf Prism Cv
LYRICA
pregabalin
CAPSULE;ORAL021446-004Dec 30, 2004RXYesNo► Subscribe► SubscribeYY ► Subscribe
Pf Prism Cv
LYRICA
pregabalin
CAPSULE;ORAL021446-007Dec 30, 2004RXYesNo► Subscribe► Subscribe► 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► 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;ORAL021446-006Dec 30, 2004► Subscribe► Subscribe
Pf Prism Cv
LYRICA
pregabalin
CAPSULE;ORAL021446-001Dec 30, 2004► Subscribe► Subscribe
Pf Prism Cv
LYRICA
pregabalin
CAPSULE;ORAL021446-004Dec 30, 2004► Subscribe► Subscribe
Pf Prism Cv
LYRICA
pregabalin
SOLUTION;ORAL022488-001Jan 4, 2010► 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;ORAL021446-002Dec 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
6,028,214 GABA and L-glutamic acid analogs for antiseizure treatment► Subscribe
5,563,175 GABA and L-glutamic acid analogs for antiseizure treatment► Subscribe
5,684,189 GABA and L-glutamic acid analogs for antiseizure treatment► Subscribe
6,525,096 GABA and L-glutamic acid analogs for antiseizure treatment► Subscribe
6,255,345 GABA and L-glutamic acid analogs for antiseizure treatment► Subscribe
6,291,526 GABA and L-glutamic acid analogs for antiseizure treatment► Subscribe
6,359,169 GABA and L-glutamic acid analogs for antiseizure treatment► Subscribe
6,414,024 GABA and L-glutamic acid analogs for antiseizure treatment► Subscribe
5,847,151 Gaba and L-glutamic acid analogs for antiseizure treatment► Subscribe
5,608,090 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
Czech Republic9402849► Subscribe
Hong Kong1021134► Subscribe
Mexico9102241► Subscribe
Hungary9403310► Subscribe
Germany122004000039► Subscribe
Russian Federation94046105► Subscribe
Brazil9710536► Subscribe
World Intellectual Property Organization (WIPO)9209560► Subscribe
World Intellectual Property Organization (WIPO)9803167► Subscribe
Luxembourg91112► 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
2004017,C0934061Lithuania► SubscribePRODUCT NAME: PREGABALINUM ((S)-3-(AMINOMETIL)-5-METILHEKSANO RUGSTIS); REGISTRATION NO/DATE: EU/1/04/279/001-025 20040725
2004 00036Denmark► Subscribe
0164Netherlands► Subscribe300164, 20130518, EXPIRES: 20180517
0641330/01Switzerland► SubscribeFORMER REPRESENTANTIVE: E. BLUM AND CO. PATENTANWAELTE, CH
/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
2004 00036Denmark► SubscribePRODUCT NAME: PREGABALIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/04/279/001-025 20040706
00164Netherlands► SubscribePRODUCT NAME: PREGABALINE, DESGEWENST IN DE; REGISTRATION NO/DATE: EU/1/04/279/001 20040706
04C/022Belgium► SubscribePRODUCT NAME: PREGABALIN; REGISTRATION NO/DATE: EU/1/04/279/001 20040708
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)
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Medtronic
UBS
Moodys
Mallinckrodt
Novartis
Dow
Covington
Colorcon
Farmers Insurance

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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