Make Better Decisions

  • Analyze global market entry opportunities
  • Identify first generic entrants
  • Drug patents in 130+ countries
➤ Start Trial

or, See Plans & Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

Teva
AstraZeneca
QuintilesIMS
Cerilliant
Merck
Daiichi Sankyo
Chinese Patent Office
Johnson and Johnson
Healthtrust
Farmers Insurance

Generated: January 20, 2018

DrugPatentWatch Database Preview

Pregabalin - Generic Drug Details

« Back to Dashboard

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

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

Pregabalin has one hundred and three patent family members in forty-four countries.

There are thirty-eight 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
➤ Subscribe➤ Subscribe25MGCAPSULE; ORAL
➤ Subscribe➤ Subscribe300MGCAPSULE; ORAL
➤ Subscribe➤ Subscribe225MGCAPSULE; ORAL

US Patents and Regulatory Information for pregabalin

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;ORAL 022488-001 Jan 4, 2010 RX Yes Yes ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Pf Prism Cv LYRICA pregabalin CAPSULE;ORAL 021446-002 Dec 30, 2004 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Pf Prism Cv LYRICA pregabalin CAPSULE;ORAL 021446-005 Dec 30, 2004 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Pfizer Inc LYRICA CR pregabalin TABLET, EXTENDED RELEASE;ORAL 209501-003 Oct 11, 2017 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Pf Prism Cv LYRICA pregabalin CAPSULE;ORAL 021446-005 Dec 30, 2004 RX Yes No ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Pfizer Inc LYRICA CR pregabalin TABLET, EXTENDED RELEASE;ORAL 209501-001 Oct 11, 2017 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Pf Prism Cv LYRICA pregabalin CAPSULE;ORAL 021446-006 Dec 30, 2004 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Pf Prism Cv LYRICA pregabalin CAPSULE;ORAL 021446-002 Dec 30, 2004 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Pfizer Inc LYRICA CR pregabalin TABLET, EXTENDED RELEASE;ORAL 209501-002 Oct 11, 2017 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Pf Prism Cv LYRICA pregabalin CAPSULE;ORAL 021446-008 Dec 30, 2004 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

Expired US Patents for pregabalin

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pf Prism Cv LYRICA pregabalin CAPSULE;ORAL 021446-003 Dec 30, 2004 ➤ Subscribe ➤ Subscribe
Pf Prism Cv LYRICA pregabalin CAPSULE;ORAL 021446-001 Dec 30, 2004 ➤ Subscribe ➤ Subscribe
Pf Prism Cv LYRICA pregabalin CAPSULE;ORAL 021446-006 Dec 30, 2004 ➤ Subscribe ➤ Subscribe
Pf Prism Cv LYRICA pregabalin CAPSULE;ORAL 021446-004 Dec 30, 2004 ➤ Subscribe ➤ Subscribe
Pf Prism Cv LYRICA pregabalin CAPSULE;ORAL 021446-002 Dec 30, 2004 ➤ Subscribe ➤ Subscribe
Pf Prism Cv LYRICA pregabalin CAPSULE;ORAL 021446-008 Dec 30, 2004 ➤ Subscribe ➤ Subscribe
Pf Prism Cv LYRICA pregabalin CAPSULE;ORAL 021446-005 Dec 30, 2004 ➤ Subscribe ➤ Subscribe
Pf Prism Cv LYRICA pregabalin CAPSULE;ORAL 021446-007 Dec 30, 2004 ➤ Subscribe ➤ Subscribe
Pf Prism Cv LYRICA pregabalin SOLUTION;ORAL 022488-001 Jan 4, 2010 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

Non-Orange Book US Patents for 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
6,262,120 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
6,414,024 GABA and L-glutamic acid analogs for antiseizure treatment ➤ Subscribe
6,359,169 GABA and L-glutamic acid analogs for antiseizure treatment ➤ Subscribe
6,291,526 GABA and L-glutamic acid analogs for antiseizure treatment ➤ Subscribe
6,342,529 GABA and L-glutamic acid analogs for antiseizure treatment ➤ Subscribe
6,525,096 GABA and L-glutamic acid analogs for antiseizure treatment ➤ Subscribe
5,599,973 GABA and L-glutamic acid analogs for antiseizure treatment ➤ Subscribe
Patent No. Title Estimated Patent Expiration

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

International Patents for pregabalin

Supplementary Protection Certificates for pregabalin

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
/2004 Austria ➤ Subscribe PRODUCT NAME: PREGABALIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES; REGISTRATION NO/DATE: EU/1/04/279/001 - EU/1/04/279/025 20040706
04C/022 Belgium ➤ Subscribe PRODUCT NAME: PREGABALIN; REGISTRATION NO/DATE: EU/1/04/279/001 20040708
C/GB04/034 United Kingdom ➤ Subscribe PRODUCT 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/
2004017,C0934061 Lithuania ➤ Subscribe PRODUCT NAME: PREGABALINUM ((S)-3-(AMINOMETIL)-5-METILHEKSANO RUGSTIS); REGISTRATION NO/DATE: EU/1/04/279/001-025 20040725
00164 Netherlands ➤ Subscribe PRODUCT NAME: PREGABALINE, DESGEWENST IN DE; REGISTRATION NO/DATE: EU/1/04/279/001 20040706
0164 Netherlands ➤ Subscribe 300164, 20130518, EXPIRES: 20180517
0641330/01 Switzerland ➤ Subscribe FORMER REPRESENTANTIVE: E. BLUM AND CO. PATENTANWAELTE, CH
C016/2004 Ireland ➤ Subscribe SPC016/2004: 20050803, EXPIRES: 20180517
2004017 Lithuania ➤ Subscribe PRODUCT NAME: PREGABALINUM ((S)-3-(AMINOMETIL)-5-METILHEKSANO RûGðTIS)
2004 00036 Denmark ➤ Subscribe
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

For more information try a trial or see the plans and pricing

Serving leading biopharmaceutical companies globally:

QuintilesIMS
Colorcon
Dow
Chinese Patent Office
Teva
Farmers Insurance
Chubb
Merck
Novartis

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.

botpot