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

Serving hundreds of leading biopharmaceutical companies globally:

Farmers Insurance
QuintilesIMS
Fish and Richardson
McKinsey
Cerilliant
Harvard Business School
US Army
Argus Health
US Department of Justice

Generated: May 27, 2018

DrugPatentWatch Database Preview

Emtricitabine - Generic Drug Details

or, see our see our flat-rate plans

« Back to Dashboard

What are the generic drug sources for emtricitabine and what is the scope of emtricitabine patent protection?

Emtricitabine
is the generic ingredient in six branded drugs marketed by Gilead, Gilead Sciences Inc, Aurobindo Pharma Ltd, Mylan Pharms Inc, and Teva Pharms Usa, and is included in nine NDAs. There are twenty-one patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

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

There are seventeen drug master file entries for emtricitabine. Four suppliers are listed for this compound. There are ten tentative approvals for this compound.
Medical Subject Heading (MeSH) Categories for emtricitabine
Synonyms for emtricitabine
.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 (JAN/USAN/INN)
Emtricitabine [USAN:INN]
Emtricitabinum
Emtritabine
Emtriva
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
Tentative approvals for EMTRICITABINE
Applicant Application No. Strength Dosage Form
➤ Try a Free Trial➤ Try a Free Trial200MGCAPSULE; ORAL
➤ Try a Free Trial➤ Try a Free Trial200MG; 300MGTABLET; ORAL
➤ Try a Free Trial➤ Try a Free Trial200MGCAPSULE; ORAL

US Patents and Regulatory Information for emtricitabine

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 COMPLERA emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate TABLET;ORAL 202123-001 Aug 10, 2011 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Gilead TRUVADA emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021752-004 Mar 10, 2016 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Gilead Sciences Inc COMPLERA emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate TABLET;ORAL 202123-001 Aug 10, 2011 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Gilead Sciences Inc COMPLERA emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate TABLET;ORAL 202123-001 Aug 10, 2011 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
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

or, see our see our flat-rate plans

Expired US Patents for emtricitabine

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

Non-Orange Book US Patents for emtricitabine

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
5,814,639 Method for the synthesis, compositions and use of 2'-deoxy-5-fluoro-3'-thiacytidine and related compounds ➤ Try a Free Trial
5,276,151 Method of synthesis of 1,3-dioxolane nucleosides ➤ Try a Free Trial
5,204,466 Method and compositions for the synthesis of BCH-189 and related compounds ➤ Try a Free Trial
6,931,679 Foldable stand for a hammock ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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

or, see our see our flat-rate plans

Supplementary Protection Certificates for emtricitabine

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2004000015 Germany ➤ Try a Free Trial PRODUCT NAME: EMTRIVA-EMTRICITABINE; REGISTRATION NO/DATE: EU/1/03/261/001-003 20031024
0851 Netherlands ➤ Try a Free Trial PRODUCT NAME: COMBINATIE VAN: - RILPIVIRINE OF EEN THERAPEUTISCH EQUIVALENTE VORM DAARVAN ZOALS BESCHERMD DOOR HET BASISOCTROOI, ZOALS EEN FARMACEUTISCH AANVAARDBAAR ZOUT VAN RILPIVIRINE, WAARONDER HET HYDROCHLORIDEZOUT VAN RILPIVIRINE; - EMTRICITABINE; EN - TENOFOVIRALAFENAMIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER TENOFOVIRALAFENAMIDEFUMARAAT; REGISTRATION NO/DATE: EU/1/16/1112 20160623
2004 Austria ➤ Try a Free Trial PRODUCT NAME: EMTRICITABIN; NAT. REGISTRATION NO/DATE: EU/1/03/261/001- EU/1/03/261/003 20031024; FIRST REGISTRATION: EU EU/1/03/261/003
C/GB04/016 United Kingdom ➤ Try a Free Trial PRODUCT NAME: EMTRICITABINE OR SALTS AND ESTERS THEREOF; REGISTERED: UK EU/1/03/261/001 20031024; UK EU/1/03/261/002 20031024; UK EU/1/03/261/003 20031024
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:

Moodys
Federal Trade Commission
AstraZeneca
McKesson
Citi
Accenture
US Army
Deloitte
Queensland Health

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.