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Last Updated: March 1, 2024

IONSYS Drug Patent Profile


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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

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  Try a Trial

Summary for IONSYS
Drug patent expirations by year for IONSYS
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

SponsorPhase
Hospital for Special Surgery, New YorkPhase 4
The Medicines CompanyPhase 4
Incline Therapeutics, Inc.Phase 3

See all IONSYS clinical trials

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
>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
>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
Japan H11216192 CONTROLLING MEMBRANE FOR MEDICATION BY ELECTRIC TRANSPORTATION ⤷  Try a Trial
New Zealand 230772 MEMBRANES SUITABLE FOR USE IN IONTOPHORETIC DELIVERY DEVICES, FOR TESTING SUCH DEVICES AND THE USE THEREOF IN SUCH DEVICES, ELECTRODES AND IN TESTING THEIR PERFORMANCE ⤷  Try a Trial
China 104519947 Self-test for analgesic product ⤷  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
0901368 C300523 Netherlands ⤷  Try a Trial PRODUCT NAME: FENTANYL; REGISTRATION NO/DATE: EU/2/11/127/001 20111006
1635783 C300653 Netherlands ⤷  Try a Trial PRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906
0836511 91265 Luxembourg ⤷  Try a Trial 91265, EXPIRES: 20210124
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.