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Tenofovir disoproxil fumarate - Generic Drug Details
What are the generic sources for tenofovir disoproxil fumarate and what is the scope of patent protection?
Tenofovir disoproxil fumarate
is the generic ingredient in two branded drugs marketed by Gilead Sciences Inc, Apotex Inc, Aurobindo Pharma Ltd, Casi Pharms Inc, Cipla, Hetero Labs Ltd Iii, Macleods Pharms Ltd, Mylan, Qilu Pharm Co Ltd, Strides Pharma, and Teva Pharms Usa, and is included in twelve NDAs. Additional information is available in the individual branded drug profile pages.There are forty-two drug master file entries for tenofovir disoproxil fumarate. Seventeen suppliers are listed for this compound. There are five tentative approvals for this compound.
Summary for tenofovir disoproxil fumarate
Recent Clinical Trials for tenofovir disoproxil fumarate
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Fundacio Lluita Contra la SIDA | Phase 2 |
| Hospital Universitari de Bellvitge | Phase 2 |
| Institut d'Investigació Biomèdica de Bellvitge | Phase 2 |
Recent Litigation for tenofovir disoproxil fumarate
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Gilead Sciences, Inc. v. Merck & Co., Inc. | 2016-07-06 |
| Gilead Sciences v. Sigmapharm Labs | 2014-05-05 |
| Gilead Sciences, Inc. v. Teva Pharmaceuticals USA, Inc. | 2010-03-05 |
See all tenofovir disoproxil fumarate litigation
PTAB Litigation
| Petitioner | Date |
|---|---|
| Mylan Pharmaceuticals Inc. | 2014-06-04 |
Generic filers with tentative approvals for TENOFOVIR DISOPROXIL FUMARATE
| Applicant | Application No. | Strength | Dosage Form |
| Start Trial | Start Trial | 300MG | TABLET; ORAL |
| Start Trial | Start Trial | 300MG | TABLET;ORAL |
| Start Trial | Start Trial | 150MG | TABLET;ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
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 |
| EX-A590 |
| FT-0082876 |
| fumaric acid bis[(isopropoxycarbonyl)oxy]methyl {[(2R)-1-(6-aminopurin-9-yl)propan-2-yl]oxy}methanephosphonate |
| GS 4331-05 |
| GS-4331-05 |
| GS-US-104-0321 |
| GSK-548470 |
| HSDB 7165 |
| HY-13782 |
| I06-1886 |
| KB-60712 |
| KS-1246 |
| LS-173814 |
| MLS004774141 |
| MolPort-009-679-412 |
| MolPort-039-010-541 |
| OTT9J7900I |
| Q-201788 |
| RP17795 |
| RTR-009415 |
| s1400 |
| SC-24733 |
| SCHEMBL2670560 |
| SCHEMBL40021 |
| SMR003500786 |
| ST2413816 |
| Tenofovir (Disoproxil Fumarate) |
| Tenofovir DF |
| Tenofovir disoproxil fumarate (JAN/USAN) |
| Tenofovir Disoproxil Fumarate [USAN] |
| Tenofovir disoproxil fumarate, >=98% (HPLC) |
| Tenofovir disoproxil fumarate, 98% |
| Tenofovir disoproxil fumarate, Pharmaceutical Secondary Standard; Certified Reference Material |
| tenofovir-disoproxil-fumarate |
| TR-009415 |
| UNII-OTT9J7900I |
| V1698 |
| VCMJCVGFSROFHV-WZGZYPNHSA-N |
| Viread |
Paragraph IV (Patent) Challenges for TENOFOVIR DISOPROXIL FUMARATE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| VIREAD | TABLET;ORAL | tenofovir disoproxil fumarate | 021356 | 2012-05-17 |
| VIREAD | TABLET;ORAL | tenofovir disoproxil fumarate | 021356 | 2010-01-26 |
US Patents and Regulatory Information for tenofovir disoproxil fumarate
Expired US Patents for tenofovir disoproxil fumarate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Gilead Sciences Inc | VIREAD | tenofovir disoproxil fumarate | TABLET;ORAL | 021356-001 | Oct 26, 2001 | Start Trial | Start Trial |
| Gilead Sciences Inc | VIREAD | tenofovir disoproxil fumarate | TABLET;ORAL | 021356-002 | Jan 18, 2012 | Start Trial | Start Trial |
| Gilead Sciences Inc | VIREAD | tenofovir disoproxil fumarate | POWDER;ORAL | 022577-001 | Jan 18, 2012 | Start Trial | Start Trial |
| Gilead Sciences Inc | VIREAD | tenofovir disoproxil fumarate | TABLET;ORAL | 021356-004 | Jan 18, 2012 | Start Trial | Start Trial |
| Gilead Sciences Inc | VIREAD | tenofovir disoproxil fumarate | TABLET;ORAL | 021356-003 | Jan 18, 2012 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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