DrugPatentWatch Database Preview
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 twelve patents protecting this drug.
The generic ingredient in IONSYS is fentanyl hydrochloride. There are thirty-one drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the fentanyl hydrochloride profile page.
Summary for IONSYS
| US Patents: | 12 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 10 |
| Clinical Trials: | 6 |
| Patent Applications: | 56 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | IONSYS at DailyMed |
Generic Entry Opportunity Date for IONSYS
*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.
Pharmacology for IONSYS
| Drug Class | Opioid Agonist |
| Mechanism of Action | Full Opioid Agonists |
Synonyms for IONSYS
| 1-(2-Phenylethyl)-4-(N-propananilido)piperidine |
| 1-Phenethyl-4-(N-phenylpropionamido)piperidine |
| 1-Phenethyl-4-N-propionylanilinopiperidine |
| 437-38-7 |
| 5-22-08-00049 (Beilstein Handbook Reference) |
| 80832-90-2 |
| 9235-EP2275420A1 |
| 9235-EP2277861A1 |
| 9235-EP2277875A2 |
| 9235-EP2280008A2 |
| 9235-EP2298764A1 |
| 9235-EP2298765A1 |
| 9235-EP2298768A1 |
| 9235-EP2305652A2 |
| 9235-EP2305654A1 |
| 9235-EP2308509A1 |
| 9235-EP2308872A1 |
| 9235-EP2314585A1 |
| 9235-EP2314590A1 |
| 9235-EP2316829A1 |
| 990-73-8 (citrate) |
| Abstral |
| AC1L1FQ2 |
| ACN-S001735 |
| Actiq |
| AK116449 |
| API0002693 |
| BDBM50008984 |
| BIDD:GT0555 |
| BRN 0494484 |
| CAS-437-38-7 |
| CF0052 |
| CHEBI:119915 |
| CHEMBL596 |
| CS-7211 |
| CTK8G2863 |
| D00320 |
| D09ISU |
| D0E1WI |
| DB00813 |
| DSSTox_CID_3049 |
| DSSTox_GSID_23049 |
| DSSTox_RID_76851 |
| DTXSID9023049 |
| Duragesic |
| Duragesic (TN) |
| Duragesic-100 |
| Duragesic-12 |
| Duragesic-25 |
| Duragesic-50 |
| Duragesic-75 |
| Durogesic |
| Durotep MT |
| effentora |
| EINECS 207-113-6 |
| Epitope ID:153507 |
| Fentanest |
| Fentanil |
| Fentanil [DCIT] |
| Fentanila |
| Fentanila [INN-Spanish] |
| Fentanilo |
| fentanyl |
| Fentanyl (JAN/USAN/INN) |
| fentanyl (transmucosal film, pain), Auxilium Pharmaceuticals |
| Fentanyl [INN:BAN] |
| Fentanyl [USAN:USP:INN:BAN] |
| Fentanyl 0.1 mg/ml in Methanol |
| Fentanyl 1.0 mg/ml in Methanol |
| Fentanyl buccal |
| Fentanyl CII |
| Fentanyl solution, 1.0 mg/mL in methanol, ampule of 1 mL, certified reference material |
| Fentanyl solution, 100 mug/mL in methanol, ampule of 1 mL, certified reference material |
| Fentanyl Transdermal System |
| Fentanyl-100 |
| Fentanyl-12 |
| Fentanyl-25 |
| Fentanyl-37 |
| Fentanyl-50 |
| Fentanyl-62 |
| Fentanyl-75 |
| Fentanyl-87 |
| FENTANYL-HCl |
| Fentanylum |
| Fentanylum [INN-Latin] |
| Fentora |
| FT-0668508 |
| GTPL1626 |
| HE006416 |
| HE343370 |
| HE343371 |
| HSDB 3329 |
| HY-U00158 |
| Instanyl |
| JNS020QD |
| L001275 |
| Lazanda |
| LS-124439 |
| Matrifen |
| N-(1-(2-phenylethyl)-4-piperidinyl)-N-phenylpropanamide |
| N-(1-Phenethyl-4-piperidinyl)-N-phenylpropionamide |
| N-(1-Phenethyl-4-piperidyl)propionanilide |
| N-(1-Phenethyl-piperidin-4-yl)-N-phenyl-propionamide |
| N-(1-Phenethyl-piperidin-4-yl)-N-phenyl-propionamide(Fentanyl) |
| N-(1-phenethylpiperidin-4-yl)-N-phenylpropanamide |
| N-(1-Phenethylpiperidin-4-yl)-N-phenylpropionamide |
| N-(1-Phenylethyl-4-piperidinyl)propionanilide |
| N-Phenethyl-4-(N-propionylanilino)piperidine |
| N-Phenyl-N-(1-(2-phenylethyl)-4-piperidinyl)propanamide |
| N-Phenyl-N-[1-(2-phenylethyl)-4-piperidinyl]propanamide # |
| N-phenyl-N-[1-(2-phenylethyl)piperidin-4-yl]propanamide |
| NCGC00168252-01 |
| Oprea1_152073 |
| Oprea1_207148 |
| pain therapy (transmucosal film), Auxilium Pharmaceuticals |
| PDSP1_000860 |
| PDSP2_000846 |
| PecFent |
| Phentanyl |
| PJMPHNIQZUBGLI-UHFFFAOYSA-N |
| Propanamide, N-phenyl-N-(1-(2-phenylethyl)-4-piperidinyl)- |
| Propanamide, N-phenyl-N-(1-(2-phenylethyl)-4-piperidinyl)- (9CI) |
| Propanamide, N-phenyl-N-[1-(2-phenylethyl)-4-piperidinyl]- |
| Propionanilide, N-(1-phenethyl-4-piperidyl)- |
| R 4263 |
| R4263 |
| SCHEMBL8804 |
| Sentonil |
| Sublimase |
| Sublimaze |
| Subsys |
| Subsys (TN) |
| Tox21_112611 |
| UF599785JZ |
| UNII-UF599785JZ |
| ZINC2522669 |
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 | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| The Medicines Co | IONSYS | fentanyl hydrochloride | SYSTEM;IONTOPHORESIS, TRANSDERMAL | 021338-001 | May 22, 2006 | DISCN | Yes | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| The Medicines Co | IONSYS | fentanyl hydrochloride | SYSTEM;IONTOPHORESIS, TRANSDERMAL | 021338-001 | May 22, 2006 | DISCN | Yes | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| The Medicines Co | IONSYS | fentanyl hydrochloride | SYSTEM;IONTOPHORESIS, TRANSDERMAL | 021338-001 | May 22, 2006 | DISCN | Yes | No | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| The Medicines Co | IONSYS | fentanyl hydrochloride | SYSTEM;IONTOPHORESIS, TRANSDERMAL | 021338-001 | May 22, 2006 | DISCN | Yes | No | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| The Medicines Co | IONSYS | fentanyl hydrochloride | SYSTEM;IONTOPHORESIS, TRANSDERMAL | 021338-001 | May 22, 2006 | DISCN | Yes | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| The Medicines Co | IONSYS | fentanyl hydrochloride | SYSTEM;IONTOPHORESIS, TRANSDERMAL | 021338-001 | May 22, 2006 | DISCN | Yes | No | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
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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 | ➤ Sign Up | ➤ Sign Up |
| The Medicines Co | IONSYS | fentanyl hydrochloride | SYSTEM;IONTOPHORESIS, TRANSDERMAL | 021338-001 | May 22, 2006 | ➤ Sign Up | ➤ Sign Up |
| The Medicines Co | IONSYS | fentanyl hydrochloride | SYSTEM;IONTOPHORESIS, TRANSDERMAL | 021338-001 | May 22, 2006 | ➤ Sign Up | ➤ Sign Up |
| The Medicines Co | IONSYS | fentanyl hydrochloride | SYSTEM;IONTOPHORESIS, TRANSDERMAL | 021338-001 | May 22, 2006 | ➤ Sign Up | ➤ Sign Up |
| The Medicines Co | IONSYS | fentanyl hydrochloride | SYSTEM;IONTOPHORESIS, TRANSDERMAL | 021338-001 | May 22, 2006 | ➤ Sign Up | ➤ Sign Up |
| The Medicines Co | IONSYS | fentanyl hydrochloride | SYSTEM;IONTOPHORESIS, TRANSDERMAL | 021338-001 | May 22, 2006 | ➤ Sign Up | ➤ Sign Up |
| The Medicines Co | IONSYS | fentanyl hydrochloride | SYSTEM;IONTOPHORESIS, TRANSDERMAL | 021338-001 | May 22, 2006 | ➤ Sign Up | ➤ Sign Up |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
Non-Orange Book US Patents for IONSYS
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration |
|---|---|---|
| 6,317,629 | Iontophoretic drug delivery apparatus | ➤ Sign Up |
| 9,645,179 | Self-test for analgesic product | ➤ Sign Up |
| 7,054,683 | Methods of electrotransport drug delivery | ➤ Sign Up |
| 6,505,069 | Electrochemically reactive cathodes for an electrotransport device | ➤ Sign Up |
| Patent No. | Title | Estimated Patent Expiration |
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International Patents for IONSYS
| Country | Document Number | Estimated Expiration |
|---|---|---|
| World Intellectual Property Organization (WIPO) | 9938564 | ➤ Sign Up |
| Australia | 2015271708 | ➤ Sign Up |
| United Kingdom | 9725542 | ➤ Sign Up |
| Portugal | 1051220 | ➤ Sign Up |
| Australia | 766913 | ➤ Sign Up |
| Russian Federation | 2232608 | ➤ Sign Up |
| Spain | 2232111 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for IONSYS
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 00522 | Netherlands | ➤ Sign Up | PRODUCT NAME: FENTANYL EN DOSERINGSAPPLICATOR; REG. NO/DATE: EU/2/11/127/001 20111006 |
| 2014000024 | Germany | ➤ Sign Up | PRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831 |
| 2006000022 | Germany | ➤ Sign Up | PRODUCT NAME: TRANSDERMAL IONTOPHORETISCH VERABREICHTES FENTANYL-HYDROCHLORID; REGISTRATION NO/DATE: EU/1/05/326/001 20060126 |
| 0653 | Netherlands | ➤ Sign Up | PRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906 |
| C/GB06/022 | United Kingdom | ➤ Sign Up | PRODUCT NAME: FENTANYL HYDROCHLORIDE; REGISTERED: UK EU/1/05/326/001 20060124 |
| 00521 | Netherlands | ➤ Sign Up | PRODUCT NAME: FENTANYL; REG NO/DATE: EU/2/11/127/001 20111006 |
| 2011000009 | Germany | ➤ Sign Up | PRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
