IONSYS Drug Patent Profile
✉ Email this page to a colleague
Which patents cover Ionsys, and what generic alternatives are available?
Ionsys is a drug marketed by The Medicines Co and is included in one NDA. There are eight patents protecting this drug.
This drug has eighty-nine patent family members in eighteen countries.
The generic ingredient in IONSYS is fentanyl hydrochloride. There are thirty-one drug master file entries for this compound. Additional details are available on the fentanyl hydrochloride profile page.
DrugPatentWatch® Generic Entry Outlook for Ionsys
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be April 1, 2024. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for IONSYS
International Patents: | 89 |
US Patents: | 8 |
Applicants: | 1 |
NDAs: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 38 |
Clinical Trials: | 7 |
Patent Applications: | 2,283 |
Formulation / Manufacturing: | see details |
DailyMed Link: | IONSYS at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for IONSYS
Generic Entry Date for IONSYS*:
Constraining patent/regulatory exclusivity:
NDA:
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.
Recent Clinical Trials for IONSYS
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
The Medicines Company | Phase 4 |
Hospital for Special Surgery, New York | Phase 4 |
The Medicines Company | Phase 3 |
Anatomical Therapeutic Chemical (ATC) Classes for IONSYS
US Patents and Regulatory Information for IONSYS
IONSYS is protected by eight US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of IONSYS is ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting IONSYS
Reservoir and a series of related reservoirs for use in an electrotransport drug delivery device and devices comprised thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Two-part electrotransport device
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Self-test for analgesic product
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD FOR IONTOPHORETIC TRANSDERMAL DELIVERY OF FENTANYL HYDROCHLORIDE
Current control for electrotransport drug delivery
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD FOR IONTOPHORETIC TRANSDERMAL DELIVERY OF FENTANYL HYDROCHLORIDE
Switch validation circuit and method
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD FOR IONTOPHORETIC TRANSDERMAL DELIVERY OF FENTANYL HYDROCHLORIDE
Self-test for analgesic product
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Method of storing an electrotransport drug delivery device
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD FOR IONTOPHORETIC TRANSDERMAL DELIVERY OF FENTANYL HYDROCHLORIDE
Switch validation circuit and method
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
The Medicines Co | IONSYS | fentanyl hydrochloride | SYSTEM;IONTOPHORESIS, TRANSDERMAL | 021338-001 | May 22, 2006 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
The Medicines Co | IONSYS | fentanyl hydrochloride | SYSTEM;IONTOPHORESIS, TRANSDERMAL | 021338-001 | May 22, 2006 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
The Medicines Co | IONSYS | fentanyl hydrochloride | SYSTEM;IONTOPHORESIS, TRANSDERMAL | 021338-001 | May 22, 2006 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
The Medicines Co | IONSYS | fentanyl hydrochloride | SYSTEM;IONTOPHORESIS, TRANSDERMAL | 021338-001 | May 22, 2006 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for IONSYS
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 | ⤷ Try a Trial | ⤷ Try a Trial |
The Medicines Co | IONSYS | fentanyl hydrochloride | SYSTEM;IONTOPHORESIS, TRANSDERMAL | 021338-001 | May 22, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
The Medicines Co | IONSYS | fentanyl hydrochloride | SYSTEM;IONTOPHORESIS, TRANSDERMAL | 021338-001 | May 22, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
The Medicines Co | IONSYS | fentanyl hydrochloride | SYSTEM;IONTOPHORESIS, TRANSDERMAL | 021338-001 | May 22, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for IONSYS
See the table below for patents covering IONSYS around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
South Korea | 20140024355 | TWO-PART ELECTROTRANSPORT DEVICE | ⤷ Try a Trial |
Portugal | 2691148 | ⤷ Try a Trial | |
Denmark | 0796127 | ⤷ Try a Trial | |
Japan | 4322304 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for IONSYS
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0836511 | 122006000022 | Germany | ⤷ Try a Trial | PRODUCT NAME: TRANSDERMAL IONTOPHORETISCH VERABREICHTES FENTANYL-HYDROCHLORID; REGISTRATION NO/DATE: EU/1/05/326/001 20060126 |
0975367 | 122011000009 | Germany | ⤷ Try a Trial | PRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831 |
1635783 | CA 2014 00016 | Denmark | ⤷ Try a Trial | PRODUCT NAME: FENTANYL I EN HVILKEN SOM HELST AF DE FORMER, DER ER BESKYTTET AF GRUNDPATENTET; REG. NO/DATE: EU/1/10/644/001-006 20100831 |
1635783 | 300653 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |