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LYRICA Drug Profile
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This drug has sixty-five patent family members in thirty-one countries.
The generic ingredient in LYRICA is pregabalin. There are twenty-nine drug master file entries for this compound. Eleven suppliers are listed for this compound. There are fifteen tentative approvals for this compound. Additional details are available on the pregabalin profile page.
Summary for Tradename: LYRICA
| Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 2 |
| Suppliers / Packagers: see list | 11 |
| Drug Prices: : | see details |
Clinical Trials for: LYRICA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Type | RLD | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Pf Prism Cv | LYRICA | pregabalin | CAPSULE;ORAL | 021446-008 | Dec 30, 2004 | RX | Yes | 6,197,819 | Dec 30, 2018 | Y | Y | ||||||||||||||||||
Pf Prism Cv | LYRICA | pregabalin | CAPSULE;ORAL | 021446-007 | Dec 30, 2004 | RX | No | 6,197,819 | Dec 30, 2018 | Y | Y | ||||||||||||||||||
Pf Prism Cv | LYRICA | pregabalin | SOLUTION;ORAL | 022488-001 | Jan 4, 2010 | RX | Yes | 6,001,876 | Dec 30, 2018 | Y | |||||||||||||||||||
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Expired Patents for Tradename: LYRICA
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Pf Prism Cv | LYRICA | pregabalin | CAPSULE;ORAL | 021446-006 | Dec 30, 2004 | 5,563,175 | <disabled> | ||||||||||||||||||||||
Pf Prism Cv | LYRICA | pregabalin | CAPSULE;ORAL | 021446-001 | Dec 30, 2004 | 5,563,175 | <disabled> | ||||||||||||||||||||||
Pf Prism Cv | LYRICA | pregabalin | CAPSULE;ORAL | 021446-008 | Dec 30, 2004 | 5,563,175 | <disabled> | ||||||||||||||||||||||
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Paragraph IV activity for: LYRICA
| 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 |
Non-Orange Book Patents for Tradename: LYRICA
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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 6,359,169 | GABA and L-glutamic acid analogs for antiseizure treatment | <disabled in preview> | |||||||||||||||||||||||||||
| 5,563,175 | GABA and L-glutamic acid analogs for antiseizure treatment | <disabled in preview> | |||||||||||||||||||||||||||
| 6,117,906 | GABA and L-glutamic acid analogs for antiseizure treatment | <disabled in preview> | |||||||||||||||||||||||||||
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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 Tradename: LYRICA
| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Japan | 2000515149 | <disabled in preview> | |||||||||||||||||||||||||||
| Luxembourg | 91112 | <disabled in preview> | |||||||||||||||||||||||||||
| Hungary | 222776 | <disabled in preview> | |||||||||||||||||||||||||||
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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: LYRICA
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 00164 | Netherlands | <disabled> | PRODUCT NAME: PREGABALINE, DESGEWENST IN DE; REGISTRATION NO/DATE: EU/1/04/279/001 20040706 | ||||||||||||||||||||||||||
| /2004 | Austria | <disabled> | PRODUCT NAME: PREGABALIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES; REGISTRATION NO/DATE: EU/1/04/279/001 - EU/1/04/279/025 20040706 | ||||||||||||||||||||||||||
| 0164 | Netherlands | <disabled> | 300164, 20130518, EXPIRES: 20180517 | ||||||||||||||||||||||||||
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