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Generated: September 26, 2018

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Emtricitabine - Generic Drug Details

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

Emtricitabine is the generic ingredient in seven branded drugs marketed by Cipla Ltd, Gilead, Gilead Sciences Inc, Amneal Pharms Co, Aurobindo Pharma Ltd, Mylan Pharms Inc, and Teva Pharms Usa, and is included in eleven 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.

There are seventeen drug master file entries for emtricitabine. Three 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 EMTRIVA emtricitabine SOLUTION;ORAL 021896-001 Sep 28, 2005 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Gilead TRUVADA emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021752-001 Aug 2, 2004 AB RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Gilead Sciences Inc DESCOVY emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 208215-001 Apr 4, 2016 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Gilead TRUVADA emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021752-001 Aug 2, 2004 AB 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 AB RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Gilead TRUVADA emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021752-001 Aug 2, 2004 AB RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Gilead Sciences Inc DESCOVY emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 208215-001 Apr 4, 2016 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

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Expired US Patents for emtricitabine

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

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International Patents for emtricitabine

Country Document Number Estimated Expiration
Australia 1367692 ➤ Try a Free Trial
Japan 3530150 ➤ Try a Free Trial
European Patent Office 0984013 ➤ Try a Free Trial
New Zealand 241625 ➤ Try a Free Trial
China 100396785 ➤ Try a Free Trial
Denmark 1439177 ➤ Try a Free Trial
Denmark 0574487 ➤ Try a Free Trial
Country Document Number Estimated Expiration

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Supplementary Protection Certificates for emtricitabine

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0021 France ➤ Try a Free Trial PRODUCT NAME: EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/07/430/001 20071213
0768 Netherlands ➤ Try a Free Trial PRODUCT NAME: COMBINATIE VAN RILPIVIRINE OF EEN THERAPEUTISCH EQUIVALENTE VORM DAARVAN DIE BESCHERMD WORDT DOOR HET BASISOCTROOI, ZOALS EEN FARMACEUTISCH AANVAARDBAAR ZOUT VAN RILPIVIRINE, WAARONDER HET HYDROCHLORIDEZOUT VAN RILPIVIRINE. TENOFOVIR, IN HET BIJZONDER TENOFOVIRDISOPROXILFUMARAAT. EN EMTRICITABINE; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128
855 Luxembourg ➤ Try a Free 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 , TENOFOVIR, EN PARTICULIER LE FUMARATE DE TENOFOVIR DISOPROXIL, ET L'EMTRICITABINE.
C0020 France ➤ Try a Free Trial PRODUCT NAME: EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/07/430/001 20071213
0513200/01 Switzerland ➤ Try a Free Trial PRODUCT NAME: EMTRICITABINE; REGISTRATION NUMBER/DATE: SWISSMEDIC 56880 25.10.2004
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
073 Luxembourg ➤ Try a Free Trial 91073, EXPIRES: 20160131
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Fuji
Daiichi Sankyo
QuintilesIMS
Julphar
Merck
Healthtrust
Accenture
Express Scripts
Citi

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