Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

Cipla
McKinsey
Chubb
Mallinckrodt
Moodys
Farmers Insurance
Colorcon
Cantor Fitzgerald
Citi

Generated: July 23, 2018

DrugPatentWatch Database Preview

EMTRIVA Drug Profile

see a sample report or, see our see our flat-rate plans

« Back to Dashboard

When do Emtriva patents expire, and what generic alternatives are available?

Emtriva is a drug marketed by Gilead and is included in two NDAs. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and seventy-six patent family members in thirty-four countries.

The generic ingredient in EMTRIVA is emtricitabine. There are seventeen drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the emtricitabine profile page.
Drug patent expirations by year for EMTRIVA
Generic Entry Opportunity Date for EMTRIVA
Generic Entry Dates for EMTRIVA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage::
CAPSULE;ORAL
Generic Entry Dates for EMTRIVA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage::
SOLUTION;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.

Medical Subject Heading (MeSH) Categories for EMTRIVA
Synonyms for EMTRIVA
.beta.-L-(-)-(2R,5S)-5-Fluoro-1-[2-(hydroxymethyl)-1,3-oxathiolan-5-yl]cytosine
(-)-.beta.-L-FTC
(-)-(2R,5S)-5-fluoro-1-[2-(hydroxymethyl)-1,3-oxathiolan-5-yl]cytosine
(-)-2'-Deoxy-5-fluoro-3'-thiacytidine
(-)-2',3'-Dideoxy-5-fluoro-3'-thiacytidine
(-)-beta-2',3'-dideoxy-5-fluoro-3'-thiacytidine
(-)-cis-4-amino-5-fluoro-1-(2-hydroxymethyl-1,3-oxathiolan-5-yl)-(1H)-pyrimidin-2-one
(-)-FTC
((-))-FTC
(2R-cis)-4-Amino-5-fluoro-1-(2-(hydroxymethyl)-1,3-oxathiolan-5-yl)-2(1H)-pyrimidinone
(2R,5S)-4-Amino-5-fluoro-1-(2-(hydroxymethyl)-1,3-oxathiolan-5-yl)pyrimidin-2(1H)-one
1-(2-(Hydroxymethyl)oxathiolan-5-yl)-5-fluorocytosine
143491-54-7
143491-57-0
145213-48-5
2-FTC
2'-Deoxy-5-fluoro-3'-oxa-4'-thiocytidine
2'-Deoxy-5-fluoro-3'-thiacytidine
2',3'-Dideoxy-3-thia-5-fluorocytidine
2',3'-Dideoxy-5-fluoro-3'-thiacytidine
2',3',5-FTC
2(1H)-Pyrimidinone, 4-amino-5-fluoro-1-((2R,5S)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl)-, rel-
2(1H)-Pyrimidinone, 4-amino-5-fluoro-1-(2-(hydroxymethyl)-1,3-oxathiolan-5-yl)-, (2R-cis)-
2(1H)-Pyrimidinone, 4-amino-5-fluoro-1-(2-(hydroxymethyl)-1,3-oxathiolan-5-yl)-, cis-
2(1H)-Pyrimidinone, 4-amino-5-fluoro-1-(2-(hydroxymethyl)-1,3-oxathiolan-5-yl)-, cis-(+-)-
2(1H)-Pyrimidinone,4-amino-5-fluoro-1-[(2R,5S)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl]-
2(1H)-Pyrimidinone,4-amino-5-fluoro-1-[(2R,5S)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl]-, rel-
24229-EP2298783A1
24229-EP2314590A1
3'-Thia-2'.3'-dideoxy-5-fluorocytidine
4-amino-5-fluoro-1-((2R,5S)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl)pyrimidin-2(1H)-one
4-Amino-5-fluoro-1-((2R,5S)-2-hydroxymethyl-[1,3]oxathiolan-5-yl)-1H-pyrimidin-2-one
4-Amino-5-fluoro-1-((2R,5S)-rel-2-(hydroxymethyl)-1,3-oxathiolan-5-yl)pyrimidin-2(1H)-one
4-amino-5-fluoro-1-[ -2- -1,3-oxathiolan-5-yl]pyrimidin-2-one
4-Amino-5-fluoro-1-[(2R,5S)-(hydroxymethyl)-1,3-oxathiolan-5-yl]-2(1H)-pyrimidinone
4-amino-5-fluoro-1-[(2R,5S)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl]-1,2-dihydropyrimidin-2-one
4-amino-5-fluoro-1-[(2R,5S)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl]pyrimidin-2-one
4-amino-5-fluoro-1-[(2R,5S)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl]pyrimidin-2(1H)-one
4-Amino-5-fluoro-1-[(2R,5S)-2-hydroxymethyl)-1,3-oxathiolan-5-yl]-2-(1H-pyrimidinone
491E570
5-Fluoro-1-((2R,5S)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl)cytosine
5-Fluoro-1-(2-(hydroxymethyl)-1,3-oxathiolan-5-yl)cytosine
5-fluoro-1-[(2R,5S)-2-(hydroxymethyl)[1,3]oxathiolan-5-yl]cytosine
524W91
AB01275429-01
ABP001074
AC1L1U3I
AC1Q4KUB
AJ-45141
AK-77224
AK174088
AKOS015853098
AKOS015894950
AM84393
AN-7243
ANW-58684
AS-14099
BC213715
BDBM50107843
Beta-L-(-)-(2R,5S)-5-Fluoro-1-[2-(hydroxymethyl)-1,3-oxathiolan-5-yl]cytosine
beta-L-2',3'-dideoxy-5-fluoro-3'-thiacytidine
BW 1592
BW 524W91
BW-524W91
BW524W91
C12599
C8H10FN3O3S
CAS-143491-57-0
CCG-220615
CE0036
CHEBI:31536
CHEMBL885
CIS-2',3'-DIDEOXY-5-FLUORO-3'-THIACTIDINE
Coviracil
Coviracil (TN)
Coviracil(TM)
CS-1370
CTK4C4432
D01199
D0S9SD
DB00879
dOTFC
DR000636
DRG-0208
DSSTox_CID_20129
DSSTox_GSID_40129
DSSTox_RID_79445
DTXSID0040129
E1007
Emtricitabin
Emtricitabina
Emtricitabine
Emtricitabine (JAN/USAN/INN)
Emtricitabine [USAN:INN]
Emtricitabinum
Emtritabine
Emtriva(TM)
EX-A150
FT-0080009
FT-0601789
FTC-(-)
FTC-((-))
FTC, (-)-
G70B4ETF4S
HE311237
HMS2089I05
HSDB 7337
HY-17427
KB-279432
KS-00000L28
KS-00001CJ2
LS-135838
LS-173184
MCULE-7141046266
MFCD00870151
MLS003882429
MLS006011556
MLS006011987
MolPort-003-986-424
NCGC00164564-01
NE44626
NU006758
PSI 5004
PSI-5004
Racivir
RCV
RL01788
RTC-020120
s1704
SBB066061
SC-17032
SCHEMBL39708
SMR002533604
ST2405540
TC-020120
TL8000958
Tox21_112193
UNII-G70B4ETF4S
UNII-ULS8902U4O component XQSPYNMVSIKCOC-NTSWFWBYSA-N
W-201247
W-201248
XQSPYNMVSIKCOC-NTSWFWBYSA-N
Z1739256297
ZINC3629271

US Patents and Regulatory Information for EMTRIVA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Gilead EMTRIVA emtricitabine CAPSULE;ORAL 021500-001 Jul 2, 2003 AB RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Gilead EMTRIVA emtricitabine SOLUTION;ORAL 021896-001 Sep 28, 2005 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Gilead EMTRIVA emtricitabine CAPSULE;ORAL 021500-001 Jul 2, 2003 AB RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Gilead EMTRIVA emtricitabine CAPSULE;ORAL 021500-001 Jul 2, 2003 AB RX Yes Yes ➤ Sign Up ➤ Sign Up 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

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

see a sample report or, see our see our flat-rate plans

Expired US Patents for EMTRIVA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Gilead EMTRIVA emtricitabine SOLUTION;ORAL 021896-001 Sep 28, 2005 ➤ Sign Up ➤ Sign Up
Gilead EMTRIVA emtricitabine CAPSULE;ORAL 021500-001 Jul 2, 2003 ➤ Sign Up ➤ Sign Up
Gilead EMTRIVA emtricitabine SOLUTION;ORAL 021896-001 Sep 28, 2005 ➤ Sign Up ➤ Sign Up
Gilead EMTRIVA emtricitabine CAPSULE;ORAL 021500-001 Jul 2, 2003 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

Paragraph IV (Patent) Challenges for EMTRIVA
Drugname Dosage Strength RLD Date
➤ Subscribe Capsules 200 mg ➤ Subscribe ➤ Sign Up

Non-Orange Book US Patents for EMTRIVA

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
5,728,575 Method of resolution of 1,3-oxathiolane nucleoside enantiomers ➤ Sign Up
6,114,343 Antiviral activity and resolution of 2-hydroxymethyl-5-(5-flurocytosin-1-yl)-1,3-oxathiolane ➤ Sign Up
7,468,436 Method of resolution and antiviral activity of 1,3-oxathiolane nucleoside enantiomers ➤ Sign Up
5,914,400 Method and compositions for the synthesis of BCH-189 and related compounds ➤ Sign Up
Patent No. Title Estimated Patent Expiration

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

see a sample report or, see our see our flat-rate plans

Supplementary Protection Certificates for EMTRIVA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
853 Luxembourg ➤ Sign Up 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 L'EMTRICITABINE
0852 Netherlands ➤ Sign Up PRODUCT NAME: COMBINATIE VAN: - RILPIVIRINEHYDROCHLORIDE OF EEN THERAPEUTISCH EQUIVALENTE VORM DAARVAN ZOALS BESCHERMD DOOR HET BASISOCTROOI; - EMTRICITABINE; EN - TENOFOVIRALAFENAMIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER TENOFOVIRALAFENAMIDEFUMARAAT; REGISTRATION NO/DATE: EU/1/16/1112 20160623
C/GB08/022 United Kingdom ➤ Sign Up PRODUCT NAME: A COMBINATION OF EFAVIRENZ, EMTRICITABINE OR A PHARMACEUTICALLY ACCEPTABLE SALT OR ESTER THEREOF, AND TENOFOVIR OR A PHARMACEUTICALLY ACCEPTABLE PRODRUG, SALT OR ESTER THEREOF, PARTICULARLY TENOFOVIR DISOPROXIL, ESPECIALLY TENOFOVIR DISOPROXIL FUMARATE; REGISTERED: UK EU/1/07/430/001 20071213
0513200/01 Switzerland ➤ Sign Up PRODUCT NAME: EMTRICITABINE; REGISTRATION NUMBER/DATE: SWISSMEDIC 56880 25.10.2004
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
US Department of Justice
Chinese Patent Office
Cipla
Healthtrust
Argus Health
Teva
Mallinckrodt
Johnson and Johnson

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.