ISOPROPYL ALCOHOL - Generic Drug Details
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What are the generic sources for isopropyl alcohol and what is the scope of freedom to operate?
Isopropyl alcohol
is the generic ingredient in one branded drug marketed by Zurex Pharma and is included in one NDA. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.Isopropyl alcohol has sixty-five patent family members in twenty-two countries.
There is one drug master file entry for isopropyl alcohol. One supplier is listed for this compound.
Summary for ISOPROPYL ALCOHOL
| International Patents: | 65 |
| US Patents: | 7 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 384 |
| Clinical Trials: | 53 |
| Patent Applications: | 5,166 |
| Formulation / Manufacturing: | see details |
| What excipients (inactive ingredients) are in ISOPROPYL ALCOHOL? | ISOPROPYL ALCOHOL excipients list |
| DailyMed Link: | ISOPROPYL ALCOHOL at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ISOPROPYL ALCOHOL
Generic Entry Date for ISOPROPYL ALCOHOL*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION;TOPICAL |
*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 ISOPROPYL ALCOHOL
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Calgary | Phase 2 |
| State University of New York at Buffalo | Phase 2/Phase 3 |
| DSM Nutritional Products, Inc. | Phase 2 |
US Patents and Regulatory Information for ISOPROPYL ALCOHOL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Zurex Pharma | ZURAGARD | isopropyl alcohol | SOLUTION;TOPICAL | 210872-001 | Apr 26, 2019 | OTC | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Zurex Pharma | ZURAGARD | isopropyl alcohol | SOLUTION;TOPICAL | 210872-001 | Apr 26, 2019 | OTC | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Zurex Pharma | ZURAGARD | isopropyl alcohol | SOLUTION;TOPICAL | 210872-001 | Apr 26, 2019 | OTC | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Zurex Pharma | ZURAGARD | isopropyl alcohol | SOLUTION;TOPICAL | 210872-001 | Apr 26, 2019 | OTC | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Zurex Pharma | ZURAGARD | isopropyl alcohol | SOLUTION;TOPICAL | 210872-001 | Apr 26, 2019 | OTC | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Zurex Pharma | ZURAGARD | isopropyl alcohol | SOLUTION;TOPICAL | 210872-001 | Apr 26, 2019 | OTC | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for ISOPROPYL ALCOHOL
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Denmark | 2986333 | ⤷ Try a Trial | |
| Brazil | PI0606969 | solução de bloqueio de cateter compreendendo citrato e um parabeno | ⤷ Try a Trial |
| South Africa | 200707348 | A catheter lock solution comprising citrate and a paraben | ⤷ Try a Trial |
| Mexico | 2019008119 | APARATO MEDICO APLICADOR PARA PIEL. (MEDICAL SKIN APPLICATOR APPARATUS.) | ⤷ Try a Trial |
| Japan | 2016515461 | 医療用皮膚塗布器装置 | ⤷ Try a Trial |
| New Zealand | 713414 | Medical skin applicator apparatus | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ISOPROPYL ALCOHOL
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2203462 | 2014029 | Norway | ⤷ Try a Trial | PRODUCT NAME: SOFOSBUVIR. (S)-ISOPROPYL 2-; NAT. REG. NO/DATE: EU/1/13/894 20140116; FIRST REG. NO/DATE: (001-002) 20140117 |
| 1920764 | 2012/033 | Ireland | ⤷ Try a Trial | PRODUCT NAME: TRAVOPROST (ALSO CALLED FLUPROSTENOL ISOPROPYL ESTER); NAT REGISTRATION NO/DATE: EU/1/01/199/001-002 20011129; FIRST REGISTRATION NO/DATE: EU/1/01/199/001-002 20011129; PAEDIATRIC INVESTIGATION PLAN: P/0298/2013 PROCEEDINGS UNDER SECTION 37 OF THE PATENTS ACT, 1992 RESTORATION ORDER DATED 12TH JANUARY 2016, WAS MADE RESTORING THE PATENT MENTIONED BELOW S85583 PAUL DOYLE A RE-USABLE BAG SYSTEM RESTORATION ORDERS DATED 16TH FEBRUARY 2016, WERE MADE RESTORING THE PATENTS MENTIONED BELOW S86133 MERVYN GREENE MULTI PURPOSE TANK STAND WITH COMPLEX LOCKING MECHANISM 86119 MPC GREEN LIMITED ANEW BIN |
| 2447254 | 2018015 | Norway | ⤷ Try a Trial | PRODUCT NAME: 2-4-(N-(5,6-DIFENYLPYRAZIN-2- YL)-N- ISOPROPYLAMINO)BUTYLOKSY-N-; REG. NO/DATE: EU/1/15/1083 20160530 |
| 1448186 | C300550 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: MENGSEL VAN CATECHOLEN GEISOLEERD UIT EEN EXTRACT VAN GROENE THEE, CAMELLIA SINENSIS, L. O. KUNTZE MET ISOPROPYLMYRISTAAT; NATL. REGISTRATION NO/DATE: RVG 110904 20120920; FIRST REGISTRATION: DE 73486.00.00 20090831 |
| 0289349 | SPC/GB04/007 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: ISOPROPYL(+)-(Z)-7-((1R,2R,3R,5S)-3,5-DIHYDROXY-2-(3-OXODECYL)CYCLOPENTYL)-5-HEPTENOATE; REGISTERED: CH 55634 01 20010329; UK PL00101/0667 20031112 |
| 1448186 | 29/2010 | Austria | ⤷ Try a Trial | PRODUCT NAME: "(-)-EPIGALLOCATECHIN GALLAT MIT ISOPROPYLMYRISTAT"; NAT. REGISTRATION NO/DATE: 1-29000 20100217; FIRST REGISTRATION: DE 73486.00.00 (MITTEILUNG) 20090908 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
