DrugPatentWatch Database Preview
SUBSYS Drug Profile
Which patents cover Subsys, and when can generic versions of Subsys launch?
Subsys is a drug marketed by Insys Dev Co Inc and is included in one NDA. There are nine patents protecting this drug and two Paragraph IV challenges.
This drug has twenty-five patent family members in fifteen countries.
The generic ingredient in SUBSYS is fentanyl. There are thirty-one drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the fentanyl profile page.
Summary for SUBSYS
| International Patents: | 25 |
| US Patents: | 9 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 26 |
| Clinical Trials: | 5 |
| Patent Applications: | 4,613 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for SUBSYS |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for SUBSYS |
| DailyMed Link: | SUBSYS at DailyMed |
Pharmacology for SUBSYS
| Drug Class | Opioid Agonist |
| Mechanism of Action | Full Opioid Agonists |
Medical Subject Heading (MeSH) Categories for SUBSYS
Synonyms for SUBSYS
| 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 |
| IONSYS |
| 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 (TN) |
| Tox21_112611 |
| UF599785JZ |
| UNII-UF599785JZ |
| ZINC2522669 |
US Patents and Regulatory Information for SUBSYS
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Insys Dev Co Inc | SUBSYS | fentanyl | SPRAY;SUBLINGUAL | 202788-005 | Jan 4, 2012 | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Insys Dev Co Inc | SUBSYS | fentanyl | SPRAY;SUBLINGUAL | 202788-004 | Jan 4, 2012 | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Insys Dev Co Inc | SUBSYS | fentanyl | SPRAY;SUBLINGUAL | 202788-006 | Aug 30, 2012 | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Insys Dev Co Inc | SUBSYS | fentanyl | SPRAY;SUBLINGUAL | 202788-007 | Aug 30, 2012 | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Insys Dev Co Inc | SUBSYS | fentanyl | SPRAY;SUBLINGUAL | 202788-006 | Aug 30, 2012 | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
Paragraph IV (Patent) Challenges for SUBSYS
| Drugname | Dosage | Strength | RLD | Date |
|---|---|---|---|---|
| ➤ Subscribe | Sublingual Spray | 0.1 mg/spray,0.2 mg/spray,0.6 mg/spray,0.8 mg/spray,1.2 mg/spray,1.6 mg/spray | ➤ Subscribe | ➤ Sign Up |
| ➤ Subscribe | Sublingual Spray | 0.4 mg/spray | ➤ Subscribe | ➤ Sign Up |
International Patents for SUBSYS
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Japan | 2009528272 | ➤ Sign Up |
| New Zealand | 569949 | ➤ Sign Up |
| Cyprus | 1117263 | ➤ Sign Up |
| Japan | 5630877 | ➤ Sign Up |
| Japan | 5241514 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for SUBSYS
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 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 |
| 2014 00016 | Denmark | ➤ Sign Up | 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 |
| 00522 | Netherlands | ➤ Sign Up | PRODUCT NAME: FENTANYL EN DOSERINGSAPPLICATOR; REG. NO/DATE: EU/2/11/127/001 20111006 |
| 00523 | Netherlands | ➤ Sign Up | PRODUCT NAME: FENTANYL; REGISTRATION NO/DATE: EU/2/11/127/001 20111006 |
| 00521 | Netherlands | ➤ Sign Up | PRODUCT NAME: FENTANYL; REG NO/DATE: EU/2/11/127/001 20111006 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
