Serving 500+ biopharmaceutical companies globally:
Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing
Serving 500+ biopharmaceutical companies globally:
Generated: July 26, 2017
What is the patent landscape for Lyrica, and when can generic versions of Lyrica launch?
Lyrica is a drug marketed by Pf Prism Cv and is included in two NDAs. There are three patents protecting this drug and two Paragraph IV challenges.| Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 2 |
| Suppliers / Packagers: see list | 11 |
| Bulk Api Vendors: see list | 62 |
| Clinical Trials: see list | 71 |
| Patent Applications: see list | 3,741 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see details |
| DailyMed Link: | LYRICA at DailyMed |
| 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 | 021446-007 | Dec 30, 2004 | RX | Yes | No | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
Pf Prism Cv | LYRICA | pregabalin | SOLUTION;ORAL | 022488-001 | Jan 4, 2010 | RX | Yes | Yes | ► 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 | 021446-007 | Dec 30, 2004 | RX | Yes | No | ► Subscribe | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
| This preview shows a limited data set Subscribe for full access, or try a Trial | |||||||||||||||||||||||||||||
Export unavailable in trial.
Subscribe for complete access.
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Pf Prism Cv | LYRICA | pregabalin | CAPSULE;ORAL | 021446-002 | 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 | 021446-003 | 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 | 021446-008 | Dec 30, 2004 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
| This preview shows a limited data set Subscribe for full access, or try a Trial | |||||||||||||||||||||||||||||
Export unavailable in trial.
Subscribe for complete access.
| Drugname | Dosage | Strength | RLD | Submissiondate |
|---|---|---|---|---|
| pregabalin | Oral Solution | 20 mg/mL | Lyrica | 5/19/2010 |
| pregabalin | Capsules | 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mg | Lyrica | 12/30/2008 |
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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 5,847,151 | Gaba and L-glutamic acid analogs for antiseizure treatment | ► Subscribe | |||||||||||||||||||||||||||
| 6,342,529 | 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 | |||||||||||||||||||||||||||
| 6,359,169 | GABA and L-glutamic acid analogs for antiseizure treatment | ► Subscribe | |||||||||||||||||||||||||||
| This preview shows a limited data set Subscribe for full access, or try a Trial | |||||||||||||||||||||||||||||
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.
Export unavailable in trial.
Subscribe for complete access.
| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Finland | 945426 | ► Subscribe | |||||||||||||||||||||||||||
| Czech Republic | 286106 | ► Subscribe | |||||||||||||||||||||||||||
| Israel | 126999 | ► Subscribe | |||||||||||||||||||||||||||
| Denmark | 0641330 | ► Subscribe | |||||||||||||||||||||||||||
| South Korea | 100491282 | ► Subscribe | |||||||||||||||||||||||||||
| This preview shows a limited data set Subscribe for full access, or try a Trial | |||||||||||||||||||||||||||||
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.
Export unavailable in trial.
Subscribe for complete access.
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 00164 | Netherlands | ► Subscribe | PRODUCT NAME: PREGABALINE, DESGEWENST IN DE; REGISTRATION NO/DATE: EU/1/04/279/001 20040706 | ||||||||||||||||||||||||||
| C016/2004 | Ireland | ► Subscribe | SPC016/2004: 20050803, EXPIRES: 20180517 | ||||||||||||||||||||||||||
| 0164 | Netherlands | ► Subscribe | 300164, 20130518, EXPIRES: 20180517 | ||||||||||||||||||||||||||
| 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 | ||||||||||||||||||||||||||
| This preview shows a limited data set Subscribe for full access, or try a Trial | |||||||||||||||||||||||||||||
Export unavailable in trial.
Subscribe for complete access.
Serving 500+ biopharmaceutical companies globally:
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.
Follow DrugPatentWatch:
Join the 22,155 others who get our Drug Patent Expiration Alerts:
