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Alprostadil - Generic Drug Details
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What are the generic drug sources for alprostadil and what is the scope of freedom to operate?
Alprostadil
is the generic ingredient in six branded drugs marketed by Teva Pharms Usa, West-ward Pharms Int, Pfizer, Pharmacia And Upjohn, Auxilium Pharms Llc, and Mylan Speciality Lp, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.There are seven drug master file entries for alprostadil. Five suppliers are listed for this compound.
Summary for alprostadil
| US Patents: | 0 |
| Tradenames: | 6 |
| Applicants: | 6 |
| NDAs: | 8 |
| Drug Master File Entries: | 7 |
| Suppliers / Packagers: | 5 |
| Bulk Api Vendors: | 77 |
| Clinical Trials: | 30 |
| Patent Applications: | 3,927 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for alprostadil |
| DailyMed Link: | alprostadil at DailyMed |
Recent Clinical Trials for alprostadil
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Shengjing Hospital | Phase 4 |
| The Hospital for Sick Children | Phase 1 |
| Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia | Phase 2 |
Recent Litigation for alprostadil
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Spy Optic Inc v. West Coast Deals Inc | 2008-02-29 |
Pharmacology for alprostadil
| 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 alprostadil
Synonyms for alprostadil
| (-)-3-hydroxy-2-(3-hydroxy-1-octenyl)-5-oxo-Cyclopentaneheptanoate |
| (-)-3-hydroxy-2-(3-hydroxy-1-octenyl)-5-oxo-Cyclopentaneheptanoic acid |
| (-)-Protaglandin E1 |
| (+)-3-hydroxy-2-(3-hydroxy-1-octenyl)-5-oxo-Cyclopentaneheptanoate |
| (+)-3-hydroxy-2-(3-hydroxy-1-octenyl)-5-oxo-Cyclopentaneheptanoic acid |
| (11?,13E,15S)-11,15-Dihydroxy-9-oxo-prost-13-en-1-oic acid |
| (11alpha,12alpha,13E,15S)-11,15-dihydroxy-9-oxoprost-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)-11-alpha,15-dihydroxy-9-oxoprost-13-enoate |
| (13E)-(15S)-11-alpha,15-dihydroxy-9-oxoprost-13-enoic acid |
| (13E)-(15S)-11,15-dihydroxy-9-oxoprost-13-enoate |
| (13E)-(15S)-11,15-dihydroxy-9-oxoprost-13-enoic acid |
| (13E)-(15S)-11alpha,15-Dihydroxy-9-oxoprost-13-enoate |
| (13e)-(15s)-11alpha,15-dihydroxy-9-oxoprost-13-enoic acid |
| (1R,2R,3R)-3-Hydroxy-2-((E)-(3S)-3-hydroxy-1-octenyl)-5-oxocyclopentaneheptanoic acid |
| 11,15-Dihydroxy-9-oxoprost-13-en-1-oate |
| 11,15-Dihydroxy-9-oxoprost-13-en-1-oic acid |
| 11,15-dihydroxy-9-oxoprost-13-en-1-oic acid (ACD/Name 4.0) |
| 119314-69-1 |
| 11alpha,15alpha-Dihydroxy-9-oxo-13-trans-prostenoic acid |
| 22299-37-2 |
| 3-Hydroxy-2-(3-hydroxy-1-octenyl)-5-oxo-cyclopentaneheptanoate |
| 3-Hydroxy-2-(3-hydroxy-1-octenyl)-5-oxo-cyclopentaneheptanoic acid |
| 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-((S,E)-3-hydroxyoct-1-enyl)-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 (JP17/USP/INN) |
| Alprostadil [USAN:USP:INN:BAN:JAN] |
| Alprostadil Prostoglandin E1 |
| Alprostadil, European Pharmacopoeia (EP) Reference Standard |
| Alprostadil, meets USP testing specifications |
| Alprostadil, United States Pharmacopeia (USP) Reference Standard |
| Alprostadil(Caverject) |
| Alprostadil(usan) |
| Alprostadilum |
| Alprostadilum [INN-Latin] |
| Alprox-TD |
| AS-16360 |
| B2154 |
| BC205461 |
| BCP01740 |
| BCP9000277 |
| BDBM50101853 |
| Befar |
| Befar (TN) |
| BG0025 |
| BIDD:GT0747 |
| BML1-F06 |
| BPBio1_001293 |
| BRD-K52459643-001-06-0 |
| BRD-K52459643-001-10-2 |
| BRD-K52459643-001-17-7 |
| BSPBio_001175 |
| BSPBio_001488 |
| C04741 |
| CAS-745-65-3 |
| Caverject |
| 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 |
| DSSTox_CID_2578 |
| DSSTox_GSID_22578 |
| DSSTox_RID_76640 |
| DTXSID9022578 |
| Edex |
| 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 |
| HMS3715K17 |
| HY-B0131 |
| IDI1_033958 |
| K274 |
| l-3-Hydroxy-2-(3-hydroxy-1-octenyl)-5-oxocyclopentaneheptanoic acid |
| l-PGE1 |
| l-Prostaglandin E1 |
| Lipoprost |
| Liprostin |
| LMFA03010134 |
| MFCD00077860 |
| Minprog |
| MLS000758964 |
| MLS001424250 |
| MolPort-003-939-183 |
| MR 256 |
| MR-256 |
| Muse |
| NC00438 |
| NCGC00016535-01 |
| NCGC00025234-02 |
| NCGC00025234-03 |
| NCGC00025234-04 |
| NCGC00025234-05 |
| NSC 165559 |
| ONO 1608 |
| PGE-1 |
| PGE1 |
| PGE1 Oligomer |
| PGE1, Prostaglandin E1, powder |
| PGE1;Prostaglandin E1 |
| PGE1alpha |
| Prestwick2_001018 |
| Prestwick3_001018 |
| Prink |
| 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, 98+% |
| Prostaglandin E1, powder, gamma-irradiated, BioXtra, suitable for cell culture |
| Prostaglandin E1, synthetic, powder, BioReagent, suitable for cell culture |
| Prostaglandin E1; PGE1 |
| Prostaglandin E1;Edex;Muse;Liprostin;Caverject |
| Prostaglandin-E1 |
| Prostaglandine E |
| Prostandin |
| Prostavasin |
| Prostin VR |
| Prostin VR Pediatric |
| Prostin VR pediatric (TN) |
| Prostivas |
| RayVa |
| RP17688 |
| s1508 |
| SAM001246840 |
| SAM001246845 |
| SAM001247093 |
| SCHEMBL33317 |
| SMP2_000271 |
| SMR000112594 |
| SR-01000597593 |
| SR-01000597593-1 |
| SR-01000597593-5 |
| SR-01000597593-6 |
| 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 alprostadil
| 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 | Start Trial | Start Trial | Start Trial | ||||
| Auxilium Pharms Llc | EDEX | alprostadil | INJECTABLE;INJECTION | 020649-004 | Jun 12, 1997 | AP | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
| Auxilium Pharms Llc | EDEX | alprostadil | INJECTABLE;INJECTION | 020649-007 | Jul 30, 1998 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Auxilium Pharms Llc | EDEX | alprostadil | INJECTABLE;INJECTION | 020649-002 | Jun 12, 1997 | AP | RX | Yes | No | Start Trial | Start Trial | Start Trial | |||
| Mylan Speciality Lp | MUSE | alprostadil | SUPPOSITORY;URETHRAL | 020700-001 | Nov 19, 1996 | RX | Yes | Yes | 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 alprostadil
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Mylan Speciality Lp | MUSE | alprostadil | SUPPOSITORY;URETHRAL | 020700-002 | Nov 19, 1996 | Start Trial | Start Trial |
| Mylan Speciality Lp | MUSE | alprostadil | SUPPOSITORY;URETHRAL | 020700-001 | Nov 19, 1996 | Start Trial | Start Trial |
| Pharmacia And Upjohn | CAVERJECT IMPULSE | alprostadil | INJECTABLE;INJECTION | 021212-001 | Jun 11, 2002 | Start Trial | Start Trial |
| Mylan Speciality Lp | MUSE | alprostadil | SUPPOSITORY;URETHRAL | 020700-002 | Nov 19, 1996 | Start Trial | Start Trial |
| Mylan Speciality Lp | MUSE | alprostadil | SUPPOSITORY;URETHRAL | 020700-001 | Nov 19, 1996 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2019, www.DrugPatentWatch.com.