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Generated: October 21, 2018

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VEMLIDY Drug Profile

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When do Vemlidy patents expire, and when can generic versions of Vemlidy launch?

Vemlidy is a drug marketed by Gilead Sciences Inc and is included in one NDA. There are four patents protecting this drug.

The generic ingredient in VEMLIDY is tenofovir alafenamide fumarate. There are forty drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the tenofovir alafenamide fumarate profile page.

Drug patent expirations by year for VEMLIDY
Generic Entry Opportunity Date for VEMLIDY
Generic Entry Date for VEMLIDY*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL

*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.

Synonyms for VEMLIDY
(S)-Isopropyl 2-(((S)-((((R)-1-(6-amino-9H-purin-9-yl)propan-2-yl)oxy)methyl)(phenoxy)phosphoryl)amino)propanoate
(S)-isopropyl 2-(((S)-((((R)-1-(6-amino-9H-purin-9-yl)propan-2-yl)oxy)methyl)(phenoxy)phosphoryl)amino)propanoate hemifumarate
1-Methylethyl N-((S)-(((1R)-2-(6-amino-9H-purin-9-yl)-1-methylethoxy)methyl)phenoxyphosphinoyl)-L-alaninate, (2E)-2-butenedioate
1392275-56-7
377091-31-1
379270-37-8
383365-04-6
4863AB
9-[(r)-2-[[(s)-[[(s)-1-(isopropoxycarbonyl)ethyl]amino]phenoxyphosphinyl]methoxy]propyl]adenine
AJ-67913
AK109983
AKOS016009341
B8021
BC600709
bis{9-[(2R,5S,7E)-2,7,10-trimethyl-5,8-dioxo-5-phenoxy-3,9-dioxa-6-aza-5lambda5-phosphaundecan-1-yl]-9H-purin-6-aminium} (2E)-but-2-enedioate
bis{propan-2-yl N-[(S)-({[(2R)-1-(6-amino-9H-purin-9-yl)propan-2-yl]oxy}methyl)(phenoxy)phosphoryl]-L-alaninate} (2E)-but-2-enedioate
C21H29N6O5P
CHEBI:90923
CHEBI:90926
CHEMBL2107825
CHEMBL2364637
CS-3366
D10428
D10605
DA-42599
DB09299
EL9943AG5J
EX-A610
FT-0700641
FWF6Q91TZO
GS 7340
GS-7339
GS-7340
GS-7340-03
GS-7340; Tenofovir alafenamide
GS-734003
GS7340
HY-15232
isopropyl (2S)-2-[[[(1R)-2-(6-aminopurin-9-yl)-1-methyl-ethoxy]methyl-phenoxy-phosphoryl]amino]propanoate
J4414G3BUK
KB-77600
KS-00000PWZ
L-Alanine, N-((R)-(((1R)-2-(6-amino-9H-purin-9-yl)-1-methylethoxy)methyl)phenoxyphosphinyl)-, 1-methylethyl ester
L-Alanine, N-((S)-(((1R)-2-(6-amino-9H-purin-9-yl)-1-methylethoxy)methyl)phenoxyphosphinyl)-, 1-methylethyl ester
L-Alanine, N-((S)-(((1R)-2-(6-amino-9H-purin-9-yl)-1-methylethoxy)methyl)phenoxyphosphinyl)-, 1-methylethyl ester, (2E)-2-butenedioate (2:1)
L-Alanine, N-[(S)-[[(1R)-2-(6-amino-9H-purin-9-yl)-1-methylethoxy]methyl]phenoxyphosphinyl]-, 1-methylethyl ester
L-Alanine, Sp-N-[[[[(1R)-2-(6-amino-9H-purin-9-yl)-1-methylethyl]oxy]methyl]phenoxyphosphinyl]-, isopropyl ester
LDEKQSIMHVQZJK-CAQYMETFSA-N
MFCD23843796
MolPort-027-835-280
N-((R)-(((1R)-2-(6-Amino-9H-purin-9-yl)-1-methylethoxy)methyl)phenoxyphosphinyl)-L-alanine 1-methylethyl ester
propan-2-yl (2S)-2-{[(S)-({[(2R)-1-(6-amino-9H-purin-9-yl)propan-2-yl]oxy}methyl)(phenoxy)phosphoryl]amino}propanoate
propan-2-yl N-[(S)-({[(2R)-1-(6-amino-9H-purin-9-yl)propan-2-yl]oxy}methyl)(phenoxy)phosphoryl]-L-alaninate
S7856
SC-20288
SCHEMBL3107149
Sp-Tenofovir-phosphonamidate, phenyl, L-alanine isopropyl ester
TENOFOVIR ALAFENAMIDE
Tenofovir Alafenamide (GS-7340)
Tenofovir Alafenamide (Prodrug of tenofovir)
Tenofovir alafenamide (USAN/INN)
Tenofovir Alafenamide [USAN:INN]
Tenofovir Alafenamide fumarate
Tenofovir alafenamide fumarate (USAN/JAN)
Tenofovir Alafenamide fumarate [USAN]
tenofovir alafenamide hemifumarate
tenofovir alagenamide
UNII-EL9943AG5J
UNII-FWF6Q91TZO
UNII-J4414G3BUK
ZINC100055899

US Patents and Regulatory Information for VEMLIDY

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Gilead Sciences Inc VEMLIDY tenofovir alafenamide fumarate TABLET;ORAL 208464-001 Nov 10, 2016 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Gilead Sciences Inc VEMLIDY tenofovir alafenamide fumarate TABLET;ORAL 208464-001 Nov 10, 2016 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Gilead Sciences Inc VEMLIDY tenofovir alafenamide fumarate TABLET;ORAL 208464-001 Nov 10, 2016 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Gilead Sciences Inc VEMLIDY tenofovir alafenamide fumarate TABLET;ORAL 208464-001 Nov 10, 2016 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Supplementary Protection Certificates for VEMLIDY

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2012009,C1419152 Lithuania ➤ Sign Up PRODUCT NAME: RILPIVIRINUM + TENOFOVIRUM DISOPROXILUM; REGISTRATION NO/DATE: EU/1/11/737/001, 2011 11 28 EU/1/11/737/002 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
1419152/02 Switzerland ➤ Sign Up PRODUCT NAME: RILPIVIRIN UND TENOFOVIR; REGISTRATION NO/DATE: SWISSMEDIC 62155 12.03.2013
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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Cipla
Boehringer Ingelheim
Fuji
Daiichi Sankyo
McKinsey
Deloitte
AstraZeneca
Queensland Health
Chinese Patent Office

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