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EDEX Drug Profile
When do Edex patents expire, and when can generic versions of Edex launch?
The generic ingredient in EDEX is alprostadil. There are seven drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the alprostadil profile page.
Summary for EDEX
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 70 |
| Patent Applications: | 2,205 |
| Drug Prices: | see details |
| DailyMed Link: | EDEX at DailyMed |
Pharmacology for EDEX
| Ingredient-type | Prostaglandins |
| Drug Class | Prostaglandin Analog Prostaglandin E1 Agonist |
| Mechanism of Action | Prostaglandin Receptor Agonists |
| Physiological Effect | Genitourinary Arterial Vasodilation Venous Vasodilation |
Medical Subject Heading (MeSH) Categories for EDEX
Synonyms for EDEX
| (-)-Protaglandin E1 |
| (11?,13E,15S)-11,15-Dihydroxy-9-oxo-prost-13-en-1-oic acid |
| (11alpha,13E,15S)-11,15-dihydroxy-9-oxoprost-13-en-1-oic acid |
| (11alpha,13E,15S)-11,15-Dihydroxy-9-oxoprost-13-enoic acid |
| (13E,15S)-11alpha,15-dihydroxy-9-oxoprost-13-en-1-oic acid |
| (13E)-(15S)-11alpha,15-Dihydroxy-9-oxoprost-13-enoate |
| (1R,2R,3R)-3-Hydroxy-2-((E)-(3S)-3-hydroxy-1-octenyl)-5-oxocyclopentaneheptanoic acid |
| 119314-69-1 |
| 11alpha,15alpha-Dihydroxy-9-oxo-13-trans-prostenoic acid |
| 22299-37-2 |
| 3-Hydroxy-2-(3-hydroxy-1-octenyl)-5-oxocyclopentaneheptanoic acid |
| 50-83-9 |
| 50865-30-0 |
| 7-((1R,2R,3R)-3-hydroxy-2-((S,E)-3-hydroxyoct-1-en-1-yl)-5-oxocyclopentyl)heptanoic acid |
| 7-[(1R,2R,3R)-3-hydroxy-2-[(E,3S)-3-hydroxyoct-1-enyl]-5-oxocyclopentyl]heptanoic acid |
| 7-[(1r,3r)-3-Hydroxy-2-[(1e,3s)-3-Hydroxyoct-1-En-1-Yl]-5-Oxocyclopentyl]heptanoic Acid |
| 7-[5-((1E)(3S)-3-hydroxyoct-1-enyl)(1R,4R,5R)-4-hydroxy-2-oxocyclopentyl]hepta noic acid |
| 745-65-3 |
| 745P653 |
| 9-oxo-11R,15S-dihydroxy-13E-prostaenoic acid |
| AB0014134 |
| AB00514004 |
| AB00514004_09 |
| AB00514004-06 |
| AB00514004-08 |
| AB2000131 |
| AC-6095 |
| AC1NQXHQ |
| AI3-62116 |
| AKOS015961103 |
| Alista |
| alprostadil |
| Alprostadil (JP15/USP/INN) |
| Alprostadil (JP17/USP/INN) |
| Alprostadil [USAN:USP:INN:BAN:JAN] |
| Alprostadil, European Pharmacopoeia (EP) Reference Standard |
| Alprostadil, meets USP testing specifications |
| Alprostadil, United States Pharmacopeia (USP) Reference Standard |
| Alprostadil(Caverject) |
| Alprostadilum |
| Alprostadilum [INN-Latin] |
| Alprox-TD |
| AS-16360 |
| B2154 |
| BC205461 |
| BCP9000277 |
| BDBM50101853 |
| Befar |
| Befar (TN) |
| BG0025 |
| BIDD:GT0747 |
| BML1-F06 |
| BPBio1_001293 |
| BRD-K52459643-001-06-0 |
| BSPBio_001175 |
| BSPBio_001488 |
| C04741 |
| CAS-745-65-3 |
| Caverject |
| Caverject (TN) |
| Caverject Impulse |
| CCG-101188 |
| CHEBI:15544 |
| CHEMBL495 |
| CPD000112594 |
| CS-1905 |
| Cyclopentaneheptanoic acid, 3-hydroxy-2-(3-hydroxy-1-octenyl)-5-oxo-, (-)- |
| Cyclopentaneheptanoic acid, 3-hydroxy-2-(3-hydroxy-1-octenyl)-5-oxo-, l- |
| D00180 |
| D0I4DQ |
| D0N2EF |
| DR001827 |
| DSSTox_CID_2578 |
| DSSTox_GSID_22578 |
| DSSTox_RID_76640 |
| DTXSID9022578 |
| Edex (TN) |
| EINECS 212-017-2 |
| EX-A1411 |
| F5TD010360 |
| FemLife |
| Femprox |
| GMVPRGQOIOIIMI-DWKJAMRDSA-N |
| GTPL1882 |
| HEI-507 |
| HMS1361K10 |
| HMS1571K17 |
| HMS1791K10 |
| HMS1989K10 |
| HMS2052L11 |
| HMS2090L08 |
| HMS2098K17 |
| HMS3268I09 |
| HMS3402K10 |
| HMS3648O17 |
| HY-B0131 |
| IDI1_033958 |
| K274 |
| l-3-Hydroxy-2-(3-hydroxy-1-octenyl)-5-oxocyclopentaneheptanoic acid |
| l-PGE1 |
| l-Prostaglandin E1 |
| Lipo-alprostadil |
| Lipoprost |
| Liprostin |
| LMFA03010134 |
| LP069786 |
| MFCD00077860 |
| Minprog |
| MLS000758964 |
| MLS001424250 |
| MolPort-003-939-183 |
| MR 256 |
| MR-256 |
| Muse |
| Muse (TN) |
| NC00438 |
| NCGC00016535-01 |
| NCGC00025234-02 |
| NCGC00025234-03 |
| NCGC00025234-04 |
| NCGC00025234-05 |
| NSC 165559 |
| ONO 1608 |
| PGE-1 |
| PGE1 |
| PGE1 Oligomer |
| PGE1;Prostaglandin E1 |
| PGE1alpha |
| Prestwick2_001018 |
| Prestwick3_001018 |
| Prink (TN) |
| Promostan |
| Prost-13-en-1-oic acid, 11,15-dihydroxy-9-oxo-, (11.alpha.,13E,15S)- |
| Prost-13-en-1-oic acid, 11,15-dihydroxy-9-oxo-, (11alpha,13E,15S)- |
| Prost-13-en-1-oic acid, 11,15-dihydroxy-9-oxo-, (11alpha,13E,15S)-, homopolymer |
| Prostaglandin E1 |
| Prostaglandin E1, >=98% (HPLC), synthetic |
| Prostaglandin E1, >=99.0% (TLC) |
| Prostaglandin E1, powder, gamma-irradiated, BioXtra, suitable for cell culture |
| Prostaglandin E1, synthetic, powder, BioReagent, suitable for cell culture |
| Prostaglandin E1;Edex;Muse;Liprostin;Caverject |
| Prostaglandin-E1 |
| Prostaglandine E |
| ProstaglandinE1 |
| Prostandin |
| Prostavasin |
| Prostin VR |
| Prostin VR Pediatric |
| Prostin VR pediatric (TN) |
| Prostivas |
| RayVa |
| RP17688 |
| RTECS HK5096000 |
| s1508 |
| SAM001246840 |
| SAM001246845 |
| SAM001247093 |
| SCHEMBL33317 |
| SMP2_000271 |
| SMR000112594 |
| SR-01000946253 |
| SR-01000946253-1 |
| ST50826271 |
| Sugiran |
| SYN3025 |
| Topiglan |
| Tox21_110482 |
| U 10136 |
| U-10,136 |
| U-10136 |
| UNII-F5TD010360 |
| Vasaprostan |
| Viridal |
| Vitaros |
| Vitaros (TN) |
| W-104416 |
| XPG |
| ZINC3813088 |
US Patents and Regulatory Information for EDEX
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Auxilium Pharms Llc | EDEX | alprostadil | INJECTABLE;INJECTION | 020649-001 | Jun 12, 1997 | DISCN | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Auxilium Pharms Llc | EDEX | alprostadil | INJECTABLE;INJECTION | 020649-007 | Jul 30, 1998 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Auxilium Pharms Llc | EDEX | alprostadil | INJECTABLE;INJECTION | 020649-003 | Jun 12, 1997 | AP | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Auxilium Pharms Llc | EDEX | alprostadil | INJECTABLE;INJECTION | 020649-002 | Jun 12, 1997 | AP | 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 |
