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Last Updated: January 28, 2020

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VEMLIDY Drug Profile

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Which patents cover Vemlidy, and what generic alternatives are available?

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

This drug has one hundred and thirty patent family members in forty-nine countries.

The generic ingredient in VEMLIDY is tenofovir alafenamide fumarate. There are forty-two 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.

US ANDA Litigation and Generic Entry Outlook for Vemlidy

Vemlidy was eligible for patent challenges on November 5, 2019.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 15, 2032. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Drug patent expirations by year for VEMLIDY
Drug Prices for VEMLIDY

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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.

Recent Clinical Trials for VEMLIDY

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Spring Bank Pharmaceuticals, Inc.Phase 2
PRA Health SciencesPhase 2
Taichung Veterans General HospitalPhase 4

See all VEMLIDY clinical trials

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
AC-29893
AC-30255
ACN-037529
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-A2641
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
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
SB16758
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
UNII-EL9943AG5J
UNII-FWF6Q91TZO
UNII-J4414G3BUK
ZINC100055899
Paragraph IV (Patent) Challenges for VEMLIDY
Tradename Dosage Ingredient NDA Submissiondate
VEMLIDY TABLET;ORAL tenofovir alafenamide fumarate 208464 2019-11-05

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   Start Trial   Start Trial Y Y   Start Trial
Gilead Sciences Inc VEMLIDY tenofovir alafenamide fumarate TABLET;ORAL 208464-001 Nov 10, 2016 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Gilead Sciences Inc VEMLIDY tenofovir alafenamide fumarate TABLET;ORAL 208464-001 Nov 10, 2016 RX Yes Yes   Start Trial   Start Trial   Start Trial
Gilead Sciences Inc VEMLIDY tenofovir alafenamide fumarate TABLET;ORAL 208464-001 Nov 10, 2016 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Gilead Sciences Inc VEMLIDY tenofovir alafenamide fumarate TABLET;ORAL 208464-001 Nov 10, 2016 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

Supplementary Protection Certificates for VEMLIDY

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1663240 92854 Luxembourg   Start Trial PRODUCT NAME: COMBINAISON DE RILPIVIRINE OU UNE FORME THERAPEUTIQUE EQUIVALENTE QUI EN DERIVE TELLE QUE PROTEGEE PAR LE BREVET DE BASE, TEL QU'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE RILPIVIRINE, INCLUANT LE SEL CHLORHYDRATE DE RILPIVIRINE, ET TENOFOVIR, EN PARTICULIER LE FUMARATE DE TENOFOVIR DISOPROXIL
1301519 C 2016 011 Romania   Start Trial PRODUCT NAME: TENOFOVIR ALAFENAMIDA SAU O SARE SAU SOLVAT AL ACESTUIA, IN SPECIAL FUMARAT DE TENOFOVIR ALAFENAMIDA; NATIONAL AUTHORISATION NUMBER: EU/1/15/1061/001-002; DATE OF NATIONAL AUTHORISATION: 20151119; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/15/1061/001-002; DATE OF FIRST AUTHORISATION IN EEA: 20151119
2487166 93354 Luxembourg   Start Trial PRODUCT NAME: COBICISTAT OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI ET ALAFENAMIDE DE TENOFOVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, EN PARTICULIER LE FUMARATE D'ALAFENAMIDE DE TENOFOVIR; AUTHORISATION NUMBER AND DATE: EU/1/15/1061
1301519 2016/014 Ireland   Start Trial PRODUCT NAME: TENOFOVIR ALAFENAMIDE OR A SALT OR SOLVATE THEREOF, IN PARTICULAR TENOFOVIR ALAFENAMIDE FUMARATE; REGISTRATION NO/DATE: EU/1/15/1061/001-EU/1/15/1061/002 20151119
1663240 122016000109 Germany   Start Trial PRODUCT NAME: KOMBINATION VON RILPIVIRIN ODER EINER THERAPEUTISCH AEQUIVALENTEN, DURCH DAS GRUNDPATENT GESCHUETZTEN FORM DAVON, Z.B. EINEM PHARMAZEUTISCH AKZEPTABLEN SALZ VON RILPIVIRIN, EINSCHLIESSLICH DES HYDROCHLORIDSALZES VON RILPIVIRIN. EMTRICITABIN UND TENOFOVIRALAFENAMID ODER EINEM PHARMAZEUTISCH AKZEPTABLEN SALZ DAVON, INSBESONDERE TENOFOVIRALAFENAMIDFUMARAT; REGISTRATION NO/DATE: EU/1/16/1112 20160621
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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