Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: October 15, 2019

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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 patent protection?

Emtricitabine is the generic ingredient in seven branded drugs marketed by Cipla, Gilead, Gilead Sciences Inc, Amneal Pharms Co, Aurobindo Pharma Ltd, Laurus Labs Ltd, Mylan, and Teva Pharms Usa, and is included in twelve NDAs. There are sixteen 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 eighteen drug master file entries for emtricitabine. Two suppliers are listed for this compound. There are ten tentative approvals for this compound.

Recent Clinical Trials for emtricitabine

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

SponsorPhase
University of NebraskaPhase 4
Janssen Pharmaceutica N.V., BelgiumPhase 1
Professor Saye Khoo MD, FRCPPhase 4

See all emtricitabine clinical trials

Recent Litigation for emtricitabine

Identify potential future generic entrants

District Court Litigation
Case NameDate
GILEAD SCIENCES, INC. v. ZYDUS PHARMACEUTICALS (USA) INC.2019-01-15
GILEAD SCIENCES, INC. v. STRIDES PHARMA, INC.2018-06-27
Gilead Sciences, Inc. v. Aurobindo Pharma Ltd.2018-05-18

See all emtricitabine litigation

Generic filers with tentative approvals for EMTRICITABINE
Applicant Application No. Strength Dosage Form
  See Pricing  See Pricing200MGCAPSULE; ORAL
  See Pricing  See Pricing200MG; 300MGTABLET; ORAL
  See Pricing  See Pricing200MGCAPSULE; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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
(-)-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]-, rel-
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-[(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-(-)-L-2',3'-DIDEOXY-3'-THIACYTIDINE; (-)-BETA-2',3'-DIDEOXY-5-FLUORO-3'-THIACYTIDINE; EMTRICITABINE; EMTRIVA
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
AKOS015853098
AKOS015894950
AM84393
AN-7243
ANW-58684
AS-14099
BC213715
BDBM50107843
BW 1592
BW 524W91
BW-524W91
BW524W91
C12599
C8H10FN3O3S
CAS-143491-57-0
CCG-220615
CE0036
CHEBI:31536
CHEMBL885
Coviracil
Coviracil(TM)
CS-1370
CTK4C4432
D01199
DB00879
dOTFC
DRG-0208
DSSTox_CID_20129
DSSTox_GSID_40129
DSSTox_RID_79445
DTXSID0040129
E1007
Emtricitabin
Emtricitabina
Emtricitabine [USAN:INN]
Emtricitabinum
Emtritabine
Emtriva
Emtriva(TM)
EX-A150
FT-0080009
FT-0601789
FTC-(-)
FTC-((-))
FTC, (-)-
G70B4ETF4S
HMS2089I05
HMS3713L12
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
PSI 5004
PSI-5004
Racivir
RCV
RL01788
RTC-020120
s1704
SB18984
SC-17032
SCHEMBL39708
SMR002533604
ST2405540
SW220172-1
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 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   See Pricing   See Pricing Y   See Pricing
Gilead TRUVADA emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021752-001 Aug 2, 2004 AB RX Yes Yes   See Pricing   See Pricing Y   See Pricing
Gilead EMTRIVA emtricitabine CAPSULE;ORAL 021500-001 Jul 2, 2003 AB RX Yes Yes   See Pricing   See Pricing Y   See Pricing
Amneal Pharms Co EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 209721-002 Aug 22, 2018 DISCN No No   See Pricing   See Pricing   See Pricing
Gilead Sciences Inc ODEFSEY emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate TABLET;ORAL 208351-001 Mar 1, 2016 RX Yes Yes   See Pricing   See Pricing Y Y   See Pricing
Gilead Sciences Inc DESCOVY emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 208215-001 Apr 4, 2016 RX Yes Yes   See Pricing   See Pricing Y   See Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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

Supplementary Protection Certificates for emtricitabine

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1663240 93382 Luxembourg   See Pricing 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 ALAFENAMIDE, OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, EN PARTICULIER LE FUMARATE DE TENOFOVIR ALAFENAMIDE; AUTHORISATION NUMBER AND DATE: EU/1/16/1112 ODEFSEY - EMTRICITABINE
0513200 SPC/GB04/016 United Kingdom   See Pricing 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
1663240 15C0071 France   See Pricing PRODUCT NAME: COMBINAISON DE RILPIVIRINE OU SES FORMES THERAPEUTIQUEMENT EQUIVALENTES PROTEGEES PAR LE BREVET DE BASE TELLES QUE LES SELS PHARMACEUTIQUEMENT ACCEPTABLES DE RILPIVIRINE Y COMPRIS LE SEL D'ACIDE CHLORHYDRIQUE DE RILPIVIRINE AINSI QUE D'EMTRICITABINE; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128
0513200 7/2004 Austria   See Pricing 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
1663240 300781 Netherlands   See Pricing PRODUCT NAME: COMBINATIE VAN RILPIVIRINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT VAN RILPIVIRINE, WAARONDER HET HYDROCHLORIDEZOUT VAN RILPIVIRINE, EN EMTRICITABINE; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128
1663240 2015/052 Ireland   See Pricing PRODUCT NAME: A COMBINATION OF RILPIVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT OF RILPIVIRINE, INCLUDING THE HYDROCHLORIDE SALT OF RILPIVIRINE, AND EMTRICITABINE; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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