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IONSYS Drug Profile
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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 nine patents protecting this drug.
This drug has one hundred and twenty-two patent family members in thirty 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.
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
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 |
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
| Sponsor | Phase |
|---|---|
| The Medicines Company | Phase 4 |
| Hospital for Special Surgery, New York | Phase 4 |
| Alza Corporation, DE, USA | Phase 3 |
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 |
International Patents for IONSYS
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Mexico | 9709365 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2015187834 | Start Trial |
| Australia | 2012238096 | Start Trial |
| Slovenia | 830176 | Start Trial |
| World Intellectual Property Organization (WIPO) | 9938565 | Start Trial |
| European Patent Office | 1051220 | Start Trial |
| >Country | >Patent Number | >Estimated 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 |
