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Details for New Drug Application (NDA): 021446
NDA 021446 describes LYRICA, which is a drug marketed by Pf Prism Cv and is included in three NDAs. It is available from ten suppliers. There are six 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-one 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-one suppliers are listed for this compound. Additional details are available on the pregabalin profile page.
Summary for 021446
| Tradename: | LYRICA |
| Applicant: | Pf Prism Cv |
| Ingredient: | pregabalin |
| Patents: | 3 |
| 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: | Dec 22, 2019 | ||||||||
| Regulatory Exclusivity Use: | INFORMATION ADDED TO THE LABELING REGARDING A 15-WEEK, RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP, PLACEBO-CONTROLLED FLEXIBLE-DOSE SAFETY AND EFFICACY STUDY OF PREGABALIN IN ADOLESCENTS (12 THROUGH 17 YEARS OLD) WITH FIBROMYALGIA | ||||||||
| Regulatory Exclusivity Expiration: | May 23, 2022 | ||||||||
| Regulatory Exclusivity Use: | NEW PATIENT POPULATION | ||||||||
| Regulatory Exclusivity Expiration: | May 3, 2021 | ||||||||
| Regulatory Exclusivity Use: | NEW PATIENT POPULATION | ||||||||
Expired US Patents for NDA 021446
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Pf Prism Cv | LYRICA | pregabalin | CAPSULE;ORAL | 021446-001 | Dec 30, 2004 | Start Trial | Start Trial |
| Pf Prism Cv | LYRICA | pregabalin | CAPSULE;ORAL | 021446-005 | Dec 30, 2004 | Start Trial | Start Trial |
| Pf Prism Cv | LYRICA | pregabalin | CAPSULE;ORAL | 021446-004 | Dec 30, 2004 | Start Trial | Start Trial |
| Pf Prism Cv | LYRICA | pregabalin | CAPSULE;ORAL | 021446-002 | Dec 30, 2004 | Start Trial | Start Trial |
| Pf Prism Cv | LYRICA | pregabalin | CAPSULE;ORAL | 021446-006 | Dec 30, 2004 | Start Trial | Start Trial |
| Pf Prism Cv | LYRICA | pregabalin | CAPSULE;ORAL | 021446-007 | Dec 30, 2004 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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