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Details for New Drug Application (NDA): 021446
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NDA 021446 describes LYRICA, which is a drug marketed by Pfizer and is included in three NDAs. It is available from eleven suppliers. There are three patents protecting this drug and six Paragraph IV challenges. Additional details are available on the LYRICA profile page.
The generic ingredient in LYRICA is pregabalin. There are forty-one drug master file entries for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the pregabalin profile page.
The generic ingredient in LYRICA is pregabalin. There are forty-one drug master file entries for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the pregabalin profile page.
Summary for 021446
| Tradename: | LYRICA |
| Applicant: | Pfizer |
| Ingredient: | pregabalin |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Medical Subject Heading (MeSH) Categories for 021446
Suppliers and Packaging for NDA: 021446
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LYRICA | pregabalin | CAPSULE;ORAL | 021446 | NDA | Parke-Davis Div of Pfizer Inc | 0071-1012 | 0071-1012-68 | 90 CAPSULE in 1 BOTTLE (0071-1012-68) |
| LYRICA | pregabalin | CAPSULE;ORAL | 021446 | NDA | Parke-Davis Div of Pfizer Inc | 0071-1013 | 0071-1013-41 | 100 BLISTER PACK in 1 CARTON (0071-1013-41) > 1 CAPSULE in 1 BLISTER PACK |
Paragraph IV (Patent) Challenges for 021446
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| LYRICA | CAPSULE;ORAL | pregabalin | 021446 | 2008-12-30 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 25MG | ||||
| Approval Date: | Dec 30, 2004 | TE: | AB | RLD: | Yes | ||||
| Regulatory Exclusivity Expiration: | May 23, 2022 | ||||||||
| Regulatory Exclusivity Use: | NEW PATIENT POPULATION | ||||||||
| Regulatory Exclusivity Expiration: | May 3, 2021 | ||||||||
| Regulatory Exclusivity Use: | NEW PATIENT POPULATION | ||||||||
| Regulatory Exclusivity Expiration: | Jun 22, 2020 | ||||||||
| Regulatory Exclusivity Use: | PEDIATRIC EXCLUSIVITY | ||||||||
Expired US Patents for NDA 021446
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Pfizer | LYRICA | pregabalin | CAPSULE;ORAL | 021446-003 | Dec 30, 2004 | Start Trial | Start Trial |
| Pfizer | LYRICA | pregabalin | CAPSULE;ORAL | 021446-001 | Dec 30, 2004 | Start Trial | Start Trial |
| Pfizer | LYRICA | pregabalin | CAPSULE;ORAL | 021446-004 | Dec 30, 2004 | Start Trial | Start Trial |
| Pfizer | LYRICA | pregabalin | CAPSULE;ORAL | 021446-002 | Dec 30, 2004 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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