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Last Updated: December 5, 2020

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IONSYS Drug Profile

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US ANDA Litigation and Generic Entry Outlook for Ionsys

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be April 19, 2022. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for IONSYS
International Patents:122
US Patents:9
Applicants:1
NDAs:1
Bulk Api Vendors: 27
Clinical Trials: 6
Patent Applications: 2,429
Formulation / Manufacturing:see details
DailyMed Link:IONSYS at DailyMed
Drug patent expirations by year for IONSYS
Generic Entry Opportunity 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
The Medicines CompanyPhase 4
Hospital for Special Surgery, New YorkPhase 4
Alza Corporation, DE, USAPhase 3

See all IONSYS clinical trials

US Patents and Regulatory Information for IONSYS

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   Start Trial   Start Trial Y   Start Trial
The Medicines Co IONSYS fentanyl hydrochloride SYSTEM;IONTOPHORESIS, TRANSDERMAL 021338-001 May 22, 2006 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
The Medicines Co IONSYS fentanyl hydrochloride SYSTEM;IONTOPHORESIS, TRANSDERMAL 021338-001 May 22, 2006 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
The Medicines Co IONSYS fentanyl hydrochloride SYSTEM;IONTOPHORESIS, TRANSDERMAL 021338-001 May 22, 2006 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
The Medicines Co IONSYS fentanyl hydrochloride SYSTEM;IONTOPHORESIS, TRANSDERMAL 021338-001 May 22, 2006 DISCN Yes No   Start Trial   Start Trial   Start Trial
The Medicines Co IONSYS fentanyl hydrochloride SYSTEM;IONTOPHORESIS, TRANSDERMAL 021338-001 May 22, 2006 DISCN Yes No   Start Trial   Start Trial   Start 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   Start Trial   Start Trial
The Medicines Co IONSYS fentanyl hydrochloride SYSTEM;IONTOPHORESIS, TRANSDERMAL 021338-001 May 22, 2006   Start Trial   Start Trial
The Medicines Co IONSYS fentanyl hydrochloride SYSTEM;IONTOPHORESIS, TRANSDERMAL 021338-001 May 22, 2006   Start Trial   Start Trial
The Medicines Co IONSYS fentanyl hydrochloride SYSTEM;IONTOPHORESIS, TRANSDERMAL 021338-001 May 22, 2006   Start Trial   Start Trial
The Medicines Co IONSYS fentanyl hydrochloride SYSTEM;IONTOPHORESIS, TRANSDERMAL 021338-001 May 22, 2006   Start Trial   Start Trial
The Medicines Co IONSYS fentanyl hydrochloride SYSTEM;IONTOPHORESIS, TRANSDERMAL 021338-001 May 22, 2006   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for IONSYS

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0901368 C300523 Netherlands   Start Trial PRODUCT NAME: FENTANYL; REGISTRATION NO/DATE: EU/2/11/127/001 20111006
0836511 SPC/GB06/022 United Kingdom   Start Trial PRODUCT NAME: FENTANYL HYDROCHLORIDE; REGISTERED: UK EU/1/05/326/001 20060124
1635783 300653 Netherlands   Start Trial PRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906
1635783 122014000024 Germany   Start Trial PRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831
1769785 C300521 Netherlands   Start Trial PRODUCT NAME: FENTANYL; REG NO/DATE: EU/2/11/127/001 20111006
0836511 CA 2006 00019 Denmark   Start Trial PRODUCT NAME: FENTANYL HYDROCHLORID
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Merck
Express Scripts
Harvard Business School
McKinsey
Dow

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.