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EMTRIVA Drug Profile

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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 two 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 eighteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the emtricitabine profile page.

US ANDA Litigation and Generic Entry Outlook for Emtriva

A generic version of EMTRIVA was approved as emtricitabine by CIPLA on July 2^nd, 2018.

Summary for EMTRIVA

International Patents:	176
US Patents:	2
Applicants:	1
NDAs:	2
Suppliers / Packagers:	2
Bulk Api Vendors:	113
Clinical Trials:	6
Patent Applications:	4,001
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for EMTRIVA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EMTRIVA
DailyMed Link:	EMTRIVA at DailyMed

See drug prices for EMTRIVA

Recent Clinical Trials for EMTRIVA

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

Sponsor	Phase
University of Minnesota - Clinical and Translational Science Institute	N/A
Merck Sharp & Dohme Corp.	N/A
National Institutes of Health (NIH)	Phase 2/Phase 3

See all EMTRIVA clinical trials

Recent Litigation for EMTRIVA

Identify potential future generic entrants

District Court Litigation

Case Name	Date
United States v. Gilead Sciences, Inc.	2019-11-06
GILEAD SCIENCES, INC. v. ZYDUS PHARMACEUTICALS (USA) INC.	2019-01-15
GILEAD SCIENCES, INC. v. STRIDES PHARMA, INC.	2018-06-27

See all EMTRIVA litigation

Pharmacology for EMTRIVA

Drug Class	Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor
Mechanism of Action	Nucleoside Reverse Transcriptase Inhibitors

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

(-)-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

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]-

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-((2S,5R)-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]-2-pyrimidinone

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

4-Amino-5-fluoro-1-[(2S,5R)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl]-2(1H)-pyrimidinone; (+)-2'-Deoxy-3'-thia-5-fluorocytidine; (2S-cis)-4-Amino-5-fluoro-1-[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

524-W-91

524W91

AB01275429-01

ABP001074

AKOS015853098

AKOS015894950

AM84393

ANW-58684

AS-14099

BDBM50107843

BW 1592

BW 524W91

BW-524W91

BW1592

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

Emtricitabine

Emtricitabine [USAN:INN]

Emtritabine

Emtriva(TM)

ent-Emtricitabine; Emtricitabine IP Impurity D

EX-A150

FT-0080009

FT-0601789

FTC

FTC-(-)

FTC-((-))

FTC, (-)-

G70B4ETF4S

HMS2089I05

HMS3713L12

HSDB 7337

HY-17427

KS-00000L28

KS-00001CJ2

LS-135838

LS-173184

MCULE-7141046266

MFCD00870151

MLS003882429

MLS006011556

MLS006011987

NCGC00164564-01

NE44626

PSI 5004

PSI-5004

Q422604

Racivir

RCV

RTC-020120

s1704

SB18984

SC-17032

SCHEMBL39708

SMR002533604

ST2405540

SW220172-1

TC-020120

Tox21_112193

UNII-G70B4ETF4S

UNII-ULS8902U4O component XQSPYNMVSIKCOC-NTSWFWBYSA-N

W-201247

W-201248

XQSPYNMVSIKCOC-NTSWFWBYSA-N

Z1739256297

ZINC3629271

Paragraph IV (Patent) Challenges for EMTRIVA

Tradename	Dosage	Ingredient	NDA	Submissiondate
EMTRIVA	CAPSULE;ORAL	emtricitabine	021500	2012-07-16

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					Y
Gilead	EMTRIVA	emtricitabine	SOLUTION;ORAL	021896-001	Sep 28, 2005		RX	Yes	Yes					Y
Gilead	EMTRIVA	emtricitabine	CAPSULE;ORAL	021500-001	Jul 2, 2003	AB	RX	Yes	Yes					Y
Gilead	EMTRIVA	emtricitabine	SOLUTION;ORAL	021896-001	Sep 28, 2005		RX	Yes	Yes					Y

Expired US Patents for EMTRIVA

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

International Patents for EMTRIVA

Country	Patent Number	Estimated Expiration
Japan	4108645
Canada	2439322
China	100396785
Hungary	211344
Mexico	9200747
Japan	2010013466
Poland	171150

Supplementary Protection Certificates for EMTRIVA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1663240	1590057-4	Sweden		PRODUCT NAME: A COMBINATION OF RILPIVIRINE, OR A PHARMACEUTICAL LY ACCEPTABLE SALT OF RILPIVIRINE, INCLUDING THE HYDROCHLORIDE SALT OF RILPIVIRINE, AND TENOFOVIR DISOPROXIL, IN PARTICULAR TENOFOVIR DISOPROXIL FUMARATE, AND EMTRICITABINE; REG. NO/DATE: EU/1/11/737 20111128
0915894	SPC/GB08/033	United Kingdom		PRODUCT NAME: TENOFOVIR DISOPROXIL AND THE SALTS (IN PARTICULAR THE FUMARATE), HYDRATES, TAUTOMERS AND SOLVATES THEREOF, TOGETHER WITH EMTRICITABINE AND EFAVIRENZ; REGISTERED: UK EU/1/07/430/001 20071213; REASON FOR LAPSE: SURRENDERED
1663240	92855	Luxembourg		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.
1663240	300851	Netherlands		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
1663240	300768	Netherlands		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
0513200	SZ 7/2004	Austria
1632232	300852	Netherlands		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