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Tenofovir disoproxil fumarate - Generic Drug Details
What are the generic drug sources for tenofovir disoproxil fumarate and what is the scope of tenofovir disoproxil fumarate freedom to operate?
Tenofovir disoproxil fumarate
is the generic ingredient in two branded drugs marketed by Gilead Sciences Inc, Apotex Inc, Aurobindo Pharma Ltd, Cipla, Hetero Labs Ltd Iii, Laurus Labs Pvt, Macleods Pharms Ltd, Qilu Pharm Co Ltd, Strides Pharma, and Teva Pharms Usa, and is included in eleven NDAs. There are four patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Tenofovir disoproxil fumarate has eighty-seven patent family members in twenty-two countries.
There are forty drug master file entries for tenofovir disoproxil fumarate. Fourteen suppliers are listed for this compound. There are nine tentative approvals for this compound.
Summary for tenofovir disoproxil fumarate
| International Patents: | 87 |
| US Patents: | 4 |
| Tradenames: | 2 |
| Applicants: | 10 |
| NDAs: | 11 |
| Drug Master File Entries: | 40 |
| Suppliers / Packagers: | 14 |
| Bulk Api Vendors: | 67 |
| Clinical Trials: | 291 |
| Patent Applications: | 2,831 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for tenofovir disoproxil fumarate |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for tenofovir disoproxil fumarate |
| DailyMed Link: | tenofovir disoproxil fumarate at DailyMed |
Pharmacology for tenofovir disoproxil fumarate
| (R)-(((((1-(6-amino-9H-purin-9-yl)propan-2-yl)oxy)methyl)phosphoryl)bis(oxy))bis(methylene) diisopropyl bis(carbonate) fumarate |
| (R)-5-((2-(6-Amino-9H-purin-9-yl)-1-methylethoxy)methyl)-2,4,6,8-tetraoxa-5-phosphanonanedioic acid, bis(1-methylethyl) ester, 5-oxide, (E)-2-butenedioate (1:1) |
| [[(1R)-2-(6-aminopurin-9-yl)-1-methyl-ethoxy]methyl-(isopropoxycarbonyloxymethoxy)phosphoryl]oxymethyl isopropyl carbonate; fumaric acid |
| [[(2R)-1-(6-aminopurin-9-yl)propan-2-yl]oxymethyl-(propan-2-yloxycarbonyloxymethoxy)phosphoryl]oxymethyl propan-2-yl carbonate; (E)-but-2-enedioic acid |
| [[(2R)-1-(6-aminopurin-9-yl)propan-2-yl]oxymethyl-(propan-2-yloxycarbonyloxymethoxy)phosphoryl]oxymethyl propan-2-yl carbonate;(E)-but-2-enedioic acid |
| 202138-50-9 |
| 9-((R)-2-((bis(((isopropoxycarbonyl)oxy)methoxy)phosphinyl)methoxy)propyl)adenine fumarate |
| 9-((R)-2-((Bis(((isopropoxycarbonyl)oxy)methoxy)phosphinyl)methoxy)propyl)adenine fumarate (1:1) |
| 9-((R)-2-((Bis(((isopropoxycarbonyl)oxy)methoxy)phosphinyl)methoxy)propyl)adenine, fumarate |
| 9-((R)-2-((bis(((isopropoxycarbonyl)oxy)methoxy)phosphinyl)methoxy)propyl)adenine,fumarate |
| AB0020710 |
| AB2000088 |
| AC1O4QO8 |
| ACN-028819 |
| AK-51342 |
| AKOS016340707 |
| AKOS025149493 |
| AM20090676 |
| AOB5580 |
| AT-15317 |
| BCP0726000258 |
| bis({[(propan-2-yloxy)carbonyl]oxy}methyl) ({[(2R)-1-(6-amino-9H-purin-9-yl)propan-2-yl]oxy}methyl)phosphonate (2E)-but-2-enedioate |
| Bis(hydroxymethyl) (((R)-2-(6-amino-9H-purin-9-yl)-1-methylethoxy)methyl)phosphonate, bis(isopropyl carbonate) (ester), fumarate (1:1) |
| C19H30N5O10P.C4H4O4 |
| CHEBI:63718 |
| CHEMBL1486 |
| CS-1346 |
| CT0141 |
| D01982 |
| D0R3FP |
| EX-A590 |
| FT-0082876 |
| fumaric acid bis[(isopropoxycarbonyl)oxy]methyl {[(2R)-1-(6-aminopurin-9-yl)propan-2-yl]oxy}methanephosphonate |
| FUMARIC ACID; PMPA PRODRUG |
| GS 4331-05 |
| GS-4331-05 |
| GS-US-104-0321 |
| GSK-548470 |
| GSK548470 |
| HSDB 7165 |
| HY-13782 |
| I06-1886 |
| KB-60712 |
| KS-1246 |
| LS-173814 |
| MLS004774141 |
| MolPort-009-679-412 |
| MolPort-039-010-541 |
| OR077617 |
| OTT9J7900I |
| PMPA-oral |
| Q-201788 |
| RP17795 |
| RTR-009415 |
| s1400 |
| SC-24733 |
| SCHEMBL2670560 |
| SCHEMBL40021 |
| SMR003500786 |
| ST2413816 |
| ST51053272 |
| Tenofovir (Disoproxil Fumarate) |
| Tenofovir DF |
| Tenofovir disoproxil fumarate (JAN/USAN) |
| Tenofovir Disoproxil Fumarate [USAN] |
| Tenofovir disoproxil fumarate, >=98% (HPLC) |
| tenofovir-disoproxil-fumarate |
| Tenofovirdisoproxilfumarate |
| Tenozet |
| TR-009415 |
| UNII-OTT9J7900I |
| V1698 |
| VCMJCVGFSROFHV-WZGZYPNHSA-N |
| Viread |
US Patents and Regulatory Information for tenofovir disoproxil fumarate
Expired US Patents for tenofovir disoproxil fumarate
International Patents for tenofovir disoproxil fumarate
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Germany | 122008000033 | ➤ Sign Up |
| Japan | 4173202 | ➤ Sign Up |
| Japan | 4628437 | ➤ Sign Up |
| Spain | 2198003 | ➤ Sign Up |
| Japan | 5398662 | ➤ Sign Up |
| Taiwan | 470748 | ➤ Sign Up |
| Spain | 2249511 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for tenofovir disoproxil fumarate
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 433 | Luxembourg | ➤ Sign Up | 91433, EXPIRES: 20220725 |
| 90001-0 | Sweden | ➤ Sign Up | PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND TENOFOVIR ALAFENAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR TENOFOVIR ALAFENAMIDE FUMARATE; REG. NO/DATE: EU/1/15/1061 20151123 |
| C0020 | France | ➤ Sign Up | PRODUCT NAME: EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/07/430/001 20071213 |
| 6 | Finland | ➤ Sign Up | |
| 0768 | Netherlands | ➤ Sign Up | PRODUCT NAME: COMBINATIE VAN RILPIVIRINE OF EEN THERAPEUTISCH EQUIVALENTE VORM DAARVAN DIE BESCHERMD WORDT DOOR HET BASISOCTROOI, ZOALS EEN FARMACEUTISCH AANVAARDBAAR ZOUT VAN RILPIVIRINE, WAARONDER HET HYDROCHLORIDEZOUT VAN RILPIVIRINE. TENOFOVIR, IN HET BIJZONDER TENOFOVIRDISOPROXILFUMARAAT. EN EMTRICITABINE; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128 |
| 2015000088 | Germany | ➤ Sign Up | PRODUCT NAME: KOMBINATION VON RILPIVIRIN ODER EINER THERAPEUTISCH AEQUIVALENTEN FORM DAVON, DIE DURCH DAS GRUNDPATENT GESCHUETZT IST, WIE Z.B EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ VON RILPIVIRIN, EINSCHLIESSLICH DES HYDROCHLORIDSALZES VON RILPIVIRIN, TENOFOVIR, INSBESONDERE TENOFOVIRDISOPROXILFUMARAT, UND EMTRICITABIN; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128 |
| 0915894/01 | Switzerland | ➤ Sign Up | PRODUCT NAME: TENOFOVIR DISOPROXILFUMARAT + EMTRICITABIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57316 21.03.2006 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
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Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2018, www.DrugPatentWatch.com.
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2018, www.DrugPatentWatch.com.
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