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Generated: June 25, 2017
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 four patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.| Tradenames: | 1 |
| Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 2 |
| Drug Master File Entries: see list | 36 |
| Suppliers / Packagers: see list | 11 |
| Bulk Api Vendors: see list | 63 |
| Clinical Trials: see list | 347 |
| Patent Applications: see list | 6,301 |
| Therapeutic Class: | Anticonvulsants |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see low prices |
| DailyMed Link: | pregabalin at DailyMed |
| Applicant | Application No. | Strength | Dosage Form |
| ► Subscribe | ► Subscribe | 25MG | CAPSULE; ORAL |
| ► Subscribe | ► Subscribe | 300MG | CAPSULE; ORAL |
| ► Subscribe | ► Subscribe | 225MG | CAPSULE; 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;ORAL | 021446-004 | Dec 30, 2004 | RX | Yes | No | 6,197,819 | ► Subscribe | Y | Y | ► Subscribe | ||||||||||||||||
Pf Prism Cv | LYRICA | pregabalin | CAPSULE;ORAL | 021446-008 | Dec 30, 2004 | RX | Yes | Yes | ► Subscribe | ► Subscribe | |||||||||||||||||||
Pf Prism Cv | LYRICA | pregabalin | CAPSULE;ORAL | 021446-004 | Dec 30, 2004 | RX | Yes | No | 6,001,876 | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Pf Prism Cv | LYRICA | pregabalin | CAPSULE;ORAL | 021446-005 | Dec 30, 2004 | RX | Yes | No | 6,001,876 | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Pf Prism Cv | LYRICA | pregabalin | CAPSULE;ORAL | 021446-008 | Dec 30, 2004 | RX | Yes | Yes | RE41920 | ► Subscribe | ► Subscribe | ||||||||||||||||||
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Pf Prism Cv | LYRICA | pregabalin | CAPSULE;ORAL | 021446-005 | Dec 30, 2004 | 5,563,175 | ► Subscribe | ||||||||||||||||||||||
Pf Prism Cv | LYRICA | pregabalin | CAPSULE;ORAL | 021446-002 | Dec 30, 2004 | 5,563,175 | ► Subscribe | ||||||||||||||||||||||
Pf Prism Cv | LYRICA | pregabalin | CAPSULE;ORAL | 021446-001 | Dec 30, 2004 | 5,563,175 | ► Subscribe | ||||||||||||||||||||||
Pf Prism Cv | LYRICA | pregabalin | SOLUTION;ORAL | 022488-001 | Jan 4, 2010 | 5,563,175 | ► Subscribe | ||||||||||||||||||||||
Pf Prism Cv | LYRICA | pregabalin | CAPSULE;ORAL | 021446-003 | Dec 30, 2004 | 5,563,175 | ► Subscribe | ||||||||||||||||||||||
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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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 5,684,189 | 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 | |||||||||||||||||||||||||||
| 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 | |||||||||||||||||||||||||||
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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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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hungary | 222339 | ► Subscribe | |||||||||||||||||||||||||||
| Australia | 9137091 | ► Subscribe | |||||||||||||||||||||||||||
| Japan | 3856816 | ► Subscribe | |||||||||||||||||||||||||||
| Portugal | 934061 | ► Subscribe | |||||||||||||||||||||||||||
| Spain | 2200184 | ► 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 Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2004017 | Lithuania | ► Subscribe | PRODUCT NAME: PREGABALINUM ((S)-3-(AMINOMETIL)-5-METILHEKSANO RûGðTIS) | ||||||||||||||||||||||||||
| 2004 00036 | Denmark | ► Subscribe | PRODUCT NAME: PREGABALIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/04/279/001-025 20040706 | ||||||||||||||||||||||||||
| 00164 | Netherlands | ► Subscribe | PRODUCT NAME: PREGABALINE, DESGEWENST IN DE; REGISTRATION NO/DATE: EU/1/04/279/001 20040706 | ||||||||||||||||||||||||||
| 2004017,C0934061 | Lithuania | ► Subscribe | PRODUCT NAME: PREGABALINUM ((S)-3-(AMINOMETIL)-5-METILHEKSANO RUGSTIS); REGISTRATION NO/DATE: EU/1/04/279/001-025 20040725 | ||||||||||||||||||||||||||
| 0164 | Netherlands | ► Subscribe | 300164, 20130518, EXPIRES: 20180517 | ||||||||||||||||||||||||||
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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.
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