Details for New Drug Application (NDA): 021338
NDA 021338 describes IONSYS, which is a drug marketed by The Medicines Co and is included in one NDA. There are seven patents protecting this drug. Additional details are available on the IONSYS profile page.
The generic ingredient in IONSYS is fentanyl hydrochloride. There is one drug master file entry for this compound. Additional details are available on the fentanyl hydrochloride profile page.
The generic ingredient in IONSYS is fentanyl hydrochloride. There is one drug master file entry for this compound. Additional details are available on the fentanyl hydrochloride profile page.
Summary for 021338
| Tradename: | IONSYS |
| Applicant: | The Medicines Co |
| Ingredient: | fentanyl hydrochloride |
| Patents: | 7 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 021338
Generic Entry Date for 021338*:
Constraining patent/regulatory exclusivity:
Dosage:
SYSTEM;IONTOPHORESIS, TRANSDERMAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SYSTEM;IONTOPHORESIS, TRANSDERMAL | Strength | EQ 40MCG BASE/ACTIVATION | ||||
| Approval Date: | May 22, 2006 | TE: | RLD: | Yes | |||||
| Patent: | 8,301,238 | Patent Expiration: | Sep 30, 2031 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 8,428,708 | Patent Expiration: | May 21, 2032 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD FOR IONTOPHORETIC TRANSDERMAL DELIVERY OF FENTANYL HYDROCHLORIDE | ||||||||
| Patent: | 8,428,709 | Patent Expiration: | Jun 11, 2032 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | METHOD FOR IONTOPHORETIC TRANSDERMAL DELIVERY OF FENTANYL HYDROCHLORIDE | ||||||||
Expired US Patents for NDA 021338
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| The Medicines Co | IONSYS | fentanyl hydrochloride | SYSTEM;IONTOPHORESIS, TRANSDERMAL | 021338-001 | May 22, 2006 | 6,181,963 | ⤷ Start Trial |
| The Medicines Co | IONSYS | fentanyl hydrochloride | SYSTEM;IONTOPHORESIS, TRANSDERMAL | 021338-001 | May 22, 2006 | 5,232,438 | ⤷ Start Trial |
| The Medicines Co | IONSYS | fentanyl hydrochloride | SYSTEM;IONTOPHORESIS, TRANSDERMAL | 021338-001 | May 22, 2006 | 5,843,014 | ⤷ Start Trial |
| The Medicines Co | IONSYS | fentanyl hydrochloride | SYSTEM;IONTOPHORESIS, TRANSDERMAL | 021338-001 | May 22, 2006 | 7,027,859 | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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