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Pregabalin - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for pregabalin?

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

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

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

Summary for Generic Name: pregabalin

Tradenames:1
Patents:4
Applicants:1
NDAs:2
Drug Master File Entries: see list35
Suppliers / Packagers: see list13
Bulk Api Vendors: see list63
Clinical Trials: see list80
Patent Applications: see list6,301
Therapeutic Class:Anticonvulsants
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:pregabalin at DailyMed

Tentative approvals for PREGABALIN

Applicant Application No. Form Dosage
► Subscribe► SubscribeCAPSULE; ORAL25MG
► Subscribe► SubscribeCAPSULE; ORAL300MG
► Subscribe► SubscribeCAPSULE; ORAL225MG
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pf Prism Cv
LYRICA
pregabalin
CAPSULE;ORAL021446-003Dec 30, 2004RXYesNo6,197,819► SubscribeYY ► Subscribe
Pf Prism Cv
LYRICA
pregabalin
CAPSULE;ORAL021446-007Dec 30, 2004RXYesNoRE41920► Subscribe ► Subscribe
Pf Prism Cv
LYRICA
pregabalin
CAPSULE;ORAL021446-004Dec 30, 2004RXYesNo6,197,819► SubscribeYY ► Subscribe
Pf Prism Cv
LYRICA
pregabalin
CAPSULE;ORAL021446-003Dec 30, 2004RXYesNo6,001,876► SubscribeY ► Subscribe
Pf Prism Cv
LYRICA
pregabalin
CAPSULE;ORAL021446-008Dec 30, 2004RXYesYes► Subscribe► 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;ORAL021446-004Dec 30, 20045,563,175► Subscribe
Pf Prism Cv
LYRICA
pregabalin
CAPSULE;ORAL021446-001Dec 30, 20045,563,175► Subscribe
Pf Prism Cv
LYRICA
pregabalin
CAPSULE;ORAL021446-005Dec 30, 20045,563,175► Subscribe
Pf Prism Cv
LYRICA
pregabalin
SOLUTION;ORAL022488-001Jan 4, 20105,563,175► Subscribe
Pf Prism Cv
LYRICA
pregabalin
CAPSULE;ORAL021446-002Dec 30, 20045,563,175► 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
6,525,096 GABA and L-glutamic acid analogs for antiseizure treatment► Subscribe
6,291,526 GABA and L-glutamic acid analogs for antiseizure treatment► Subscribe
5,563,175 GABA and L-glutamic acid analogs for antiseizure treatment► Subscribe
6,255,345 GABA and L-glutamic acid analogs for antiseizure treatment► Subscribe
6,342,529 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
World Intellectual Property Organization (WIPO)9209560► Subscribe
Czech Republic286106► Subscribe
Portugal934061► Subscribe
Mexico9302970► Subscribe
Netherlands300164► 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
2004017Lithuania► SubscribePRODUCT NAME: PREGABALINUM ((S)-3-(AMINOMETIL)-5-METILHEKSANO RûGðTIS)
2004 00036Denmark► SubscribePRODUCT NAME: PREGABALIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/04/279/001-025 20040706
112Luxembourg► Subscribe91112, EXPIRES: 20180518
04C/022Belgium► SubscribePRODUCT NAME: PREGABALIN; REGISTRATION NO/DATE: EU/1/04/279/001 20040708
0641330/01Switzerland► SubscribeFORMER REPRESENTANTIVE: E. BLUM AND CO. PATENTANWAELTE, CH
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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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