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Details for New Drug Application (NDA): 022307
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NDA 022307 describes EFFIENT, which is a drug marketed by Eli Lilly And Co and is included in one NDA. It is available from one supplier. Additional details are available on the EFFIENT profile page.
The generic ingredient in EFFIENT is prasugrel hydrochloride. There are nineteen drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the prasugrel hydrochloride profile page.
The generic ingredient in EFFIENT is prasugrel hydrochloride. There are nineteen drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the prasugrel hydrochloride profile page.
Summary for 022307
| Tradename: | EFFIENT |
| Applicant: | Eli Lilly And Co |
| Ingredient: | prasugrel hydrochloride |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 022307
| Mechanism of Action | P2Y12 Receptor Antagonists |
| Physiological Effect | Decreased Platelet Aggregation |
Medical Subject Heading (MeSH) Categories for 022307
Suppliers and Packaging for NDA: 022307
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| EFFIENT | prasugrel hydrochloride | TABLET;ORAL | 022307 | NDA | Eli Lilly and Company | 0002-5121 | 0002-5121-30 | 30 TABLET, FILM COATED in 1 BOTTLE (0002-5121-30) |
| EFFIENT | prasugrel hydrochloride | TABLET;ORAL | 022307 | NDA | Eli Lilly and Company | 0002-5121 | 0002-5121-52 | 24 BLISTER PACK in 1 CARTON (0002-5121-52) > 1 TABLET, FILM COATED in 1 BLISTER PACK (0002-5121-01) |
Paragraph IV (Patent) Challenges for 022307
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| EFFIENT | TABLET;ORAL | prasugrel hydrochloride | 022307 | 2013-07-10 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 5MG BASE | ||||
| Approval Date: | Jul 10, 2009 | TE: | AB | RLD: | Yes | ||||
| Regulatory Exclusivity Expiration: | Jan 12, 2020 | ||||||||
| Regulatory Exclusivity Use: | PEDIATRIC EXCLUSIVITY | ||||||||
| Regulatory Exclusivity Expiration: | Jul 12, 2019 | ||||||||
| Regulatory Exclusivity Use: | UPDATES TO THE PRODUCT LABELING BASED ON THE RESULTS OF STUDY H7T-MC-TADO TITLED, 'A PHASE 3 DOUBLE-BLIND, RANDOMIZED, MULTICENTER, EFFICACY AND SAFETY STUDY OF PRASUGREL COMPARED TO PLACEBO IN PEDIATRIC PATIENTS WITH SICKLE CELL DISEASE' | ||||||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 10MG BASE | ||||
| Approval Date: | Jul 10, 2009 | TE: | AB | RLD: | Yes | ||||
| Regulatory Exclusivity Expiration: | Jan 12, 2020 | ||||||||
| Regulatory Exclusivity Use: | PEDIATRIC EXCLUSIVITY | ||||||||
Expired US Patents for NDA 022307
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Eli Lilly And Co | EFFIENT | prasugrel hydrochloride | TABLET;ORAL | 022307-001 | Jul 10, 2009 | Start Trial | Start Trial |
| Eli Lilly And Co | EFFIENT | prasugrel hydrochloride | TABLET;ORAL | 022307-002 | Jul 10, 2009 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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