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: December 9, 2019

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Lamivudine - Generic Drug Details

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What are the generic sources for lamivudine and what is the scope of freedom to operate?

Lamivudine is the generic ingredient in ten branded drugs marketed by Viiv Hlthcare, Glaxosmithkline, Aurobindo Pharma Ltd, Lannett Co Inc, Annora, Apotex, Apotex Inc, Arise, Cipla, Eci Pharms Llc, Hetero Labs Ltd V, Lupin Ltd, Macleods Pharms Ltd, Mylan, Mylan Labs Ltd, Strides Pharma, Micro Labs, Merck Sharp Dohme, Celltrion, Anda Repository, Hetero Labs Ltd Iii, Pharmacare, and Teva Pharms, and is included in forty-one NDAs. There are five patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

There are twenty-nine drug master file entries for lamivudine. Twenty-three suppliers are listed for this compound. There are forty-five tentative approvals for this compound.

Drug Prices for lamivudine

See drug prices for lamivudine

Recent Clinical Trials for lamivudine

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

SponsorPhase
Ospedale Amedeo di SavoiaPhase 3
Azienda Ospedaliera San PaoloPhase 3
Ospedale Policlinico San MartinoPhase 3

See all lamivudine clinical trials

Recent Litigation for lamivudine

Identify potential future generic entrants

District Court Litigation
Case NameDate
Glaxo Group Ltd. v. Lupin Ltd.2008-08-29

See all lamivudine litigation

Generic filers with tentative approvals for LAMIVUDINE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial150MG; 300MG; 200MGTABLET; ORAL
  Start Trial  Start Trial150MG; 300MG; 600MGTABLET; ORAL
  Start Trial  Start Trial150MG; 300MG; 300MGTABLET; 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 lamivudine
Synonyms for lamivudine
.beta.-L-(-)-2',3'-dideoxy-3'-thiacytidine & Sho-Saiko-To
(-)-(2'R,5'S)-1-[2'-Hydroxymethyl-5'-(1,3-oxathiolanyl)]cytosine
(-)-1-((2R,5S)-2-(Hydroxymethyl)-1,3-oxathiolan-5-yl)cytosine
(-)-1-[(2R,5S)-2-(Hydroxymethyl)-1,3-oxathiolan-5-yl]cytosine
(-)-2'-Deoxy-3'-thiacytidine
(-)-BCH 189
(-)-BCH-189
(-)-L-2',3'-DIDEOXY-3'-THIACYTIDINE; LAMIVUDINE; EPIVIR
(-)-SddC
(-)NGPB-21
(+/-) (Cis)-1-[2-(Hydroxymethyl)-1,3-oxathiolan-5-yl]cytosine
(+/-)-(cis)-4-Amino-1-(2-hydroxymethyl-1,3-oxathiolan-5-yl)-(1H)-pyrimidin-2-one
(+/-)-3TC
(+/-)-BCH-189
(+/-)-SddC
(2R,5S)-1-[2-(Hydroxymethyl)-1,3-oxathiolan-5-yl]cytosine
(2R,cis)-4-amino-1-(2-hydroxymethyl-1,3-oxathiolan-5-yl)-(1H)-pyrimidin-2-one
1117764-41-6
134678-17-4
136891-12-8
2',3'-Dideoxy-3'-thiacytidine
2(1H)-Pyrimidinone, 4-amino-1-((2R,5S)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl)-
2(1H)-Pyrimidinone, 4-amino-1-(2-(hydroxymethyl)-1,3-oxathiolan-5-yl)-, (2R-cis)-
2(1H)-Pyrimidinone, 4-amino-1-[(2R,5S)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl]-
2(1H)-Pyrimidinone, 4-amino-1-[2-(hydroxymethyl)-1,3-oxathiolan-5-yl], (-)(2R,5S) & Galanthus Nivalis Agglutinin (GNA)
2(1H)-Pyrimidinone, 4-amino-1-[2-(hydroxymethyl)-1,3-oxathiolan-5-yl], (-)(2R,5S) & Hippeastrum hybrid agglutinin( HHA)
2(1H)-Pyrimidinone, 4-amino-1-[2-(hydroxymethyl)-1,3-oxathiolan-5-yl], (+/-) (Cis)
200973-EP2272825A2
24222-EP2269989A1
24222-EP2272516A2
24222-EP2272825A2
24222-EP2292227A2
24222-EP2298761A1
24222-EP2298783A1
24222-EP2305243A1
24222-EP2305640A2
24222-EP2305680A2
24222-EP2314590A1
2T8Q726O95
3-[(5S,2R)-2-(hydroxymethyl)(1,3-oxathiolan-5-yl)]-6-amino-3-hydropyrimidin-2- one
3'-Thia-2',3'-dideoxycytidine
3TC
3TC (AIDS INITIATIVE) (AIDS INITIATIVE)
3TC & GNA
3TC & SST
3TC and NV-01
4-Amino-1-((2R,5S)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl)-2(1H)-pyrimidinone
4-amino-1-((2R,5S)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl)pyrimidin-2(1H)-one
4-Amino-1-(cis-2-(hydroxymethyl)-1,3-oxathiolan-5-yl)pyrimidin-2(1H)-one
4-amino-1-[(2R,5S)-2-(hydroxymethyl)-[1,3]-oxathiolan-5-yl]-(1H)-pyrimidin-2-one
4-amino-1-[(2R,5S)-2-(hydroxymethyl)-1,3-Oxathiolan-5-yl]-(1H)-pyrimidin-2-one
4-AMINO-1-[(2R,5S)-2-(HYDROXYMETHYL)-1,3-OXATHIOLAN-5-YL]-1,2-DIHYDROPYRIMIDIN-2-ONE
4-AMINO-1-[(2R,5S)-2-(HYDROXYMETHYL)-1,3-OXATHIOLAN-5-YL]-2(1H)-PYRIMIDINONE
4-amino-1-[(2R,5S)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl]pyrimidin-2-one
4-amino-1-[(2R,5S)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl]pyrimidin-2(1H)-one
480434-79-5
678L174
AB00639995_09
AB00639995-06
AB00639995-08
AB07588
AC-1416
AC1L1TZZ
AC1Q6C34
AJ-08348
AK105888
AK481424
AKOS005622556
AKOS015854841
AN-7245
ANW-43098
BBL033871
BC206089
BCH 189
BCH 189, (-)-
BCH-189
BCH-790
BDBM50366817
beta-L-2',3'-Dideoxy-3'-thiacytidine
beta-L-3'-Thia-2',3'-dideoxycytidine
BIDD:GT0033
C07065
C8H11N3O3S
CCG-100984
CCRIS 9274
CHEBI:63577
CHEMBL141
CIS-LAMIVUDINE
cis(+/-)-4-amino-1-[2-(hydroxymethyl)-1,3-oxathiolan-5-yl]-2(1H)-pyrimidinone
CJ-00130
CPD000466319
CS-2230
CTK3J2124
D00353
DB00709
DRG-0126
DTHC
Epivir
Epivir (TN)
Epivir-HBV
Epivir(TM)
FT-0082667
FT-0601626
FT-0650554
GG-714
GR 109714X
GR-109714X
GR109714X
Hepitec
Heptivir
Heptodin
Heptovir
HHA & 3TC
HHA & Lamivudine
HMS2051D21
HMS3259F08
HMS3713C16
HSDB 7155
HY-B0250
J-700183
J10244
JTEGQNOMFQHVDC-NKWVEPMBSA-N
KB-239893
KS-0000023D
KS-1073
L0217
Lamivir
Lamivudin
Lamivudina
Lamivudine (EPIVIR)
Lamivudine (JAN/USP/INN)
Lamivudine [USAN:BAN:INN]
Lamivudine [USAN:INN:BAN]
Lamivudine [USAN:USP:INN:BAN]
Lamivudine & GNA
lamivudine & TNF-alpha & IFN-gamma
Lamivudine for system suitability 1, European Pharmacopoeia (EP) Reference Standard
Lamivudine for system suitability 2, European Pharmacopoeia (EP) Reference Standard
Lamivudine, >=98% (HPLC), powder
Lamivudine, 1.0 mg/mL in methanol, certified reference material
Lamivudine, 98%
Lamivudine, British Pharmacopoeia (BP) Reference Standard
Lamivudine, European Pharmacopoeia (EP) Reference Standard
Lamivudine, Pharmaceutical Secondary Standard; Certified Reference Material
Lamivudine, United States Pharmacopeia (USP) Reference Standard
Lamivudinum
LMV
LS-2107
M-9795
MCULE-2096184994
MFCD00869739
MLS000759424
MLS001424097
MLS006011910
MolPort-002-507-347
NC00234
NC00705
NCGC00159341-04
NCGC00159341-05
NSC620753
PYR356
Q-201275
RL01569
RTC-020973
s1706
SAM001246582
SAM002589994
SBB066293
SC-15184
SCHEMBL109675
SMR000466319
SR-01000759420
SR-01000759420-5
ST24030826
STK801940
SW197614-3
UNII-2T8Q726O95
ZB000700
Zeffix
Zefix
ZINC12346

US Patents and Regulatory Information for lamivudine

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Strides Pharma LAMIVUDINE AND ZIDOVUDINE lamivudine; zidovudine TABLET;ORAL 079128-001 May 13, 2015 AB RX No No   Start Trial   Start Trial   Start Trial
Cipla LAMIVUDINE AND ZIDOVUDINE lamivudine; zidovudine TABLET;ORAL 077411-001 Sep 7, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Mylan Labs Ltd LAMIVUDINE lamivudine TABLET;ORAL 078545-002 Mar 5, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Merck Sharp Dohme DUTREBIS lamivudine; raltegravir potassium TABLET;ORAL 206510-001 Feb 6, 2015 DISCN No No   Start Trial   Start Trial Y   Start Trial
Merck Sharp Dohme DUTREBIS lamivudine; raltegravir potassium TABLET;ORAL 206510-001 Feb 6, 2015 DISCN No No   Start Trial   Start Trial Y   Start Trial
>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 lamivudine

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline EPIVIR-HBV lamivudine TABLET;ORAL 021003-001 Dec 8, 1998   Start Trial   Start Trial
Viiv Hlthcare EPIVIR lamivudine TABLET;ORAL 020564-003 Jun 24, 2002   Start Trial   Start Trial
Glaxosmithkline EPIVIR-HBV lamivudine SOLUTION;ORAL 021004-001 Dec 8, 1998   Start Trial   Start Trial
Glaxosmithkline EPIVIR-HBV lamivudine TABLET;ORAL 021003-001 Dec 8, 1998   Start Trial   Start Trial
Viiv Hlthcare EPIVIR lamivudine TABLET;ORAL 020564-003 Jun 24, 2002   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

McKinsey
Dow
McKesson
Baxter
Merck
Boehringer Ingelheim

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