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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
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Cipla
McKesson
Cantor Fitzgerald
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Generated: August 16, 2018

DrugPatentWatch Database Preview

Telbivudine - Generic Drug Details

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

Telbivudine is the generic ingredient in one branded drug marketed by Novartis and is included in two NDAs. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Telbivudine has sixty patent family members in twenty-one countries.

There are two drug master file entries for telbivudine.

Summary for telbivudine
International Patents:60
US Patents:7
Tradenames:1
Applicants:1
NDAs:2
Drug Master File Entries: 2
Bulk Api Vendors: 53
Clinical Trials: 75
Patent Applications: 1,625
Formulation / Manufacturing:see details
DailyMed Link:telbivudine at DailyMed
Synonyms for telbivudine
1-((2S,4R,5S)-4-hydroxy-5-(hydroxymethyl)tetrahydrofuran-2-yl)-5-methylpyrimidine-2,4(1H,3H)-dione
1-((2S,4S,5S)-4-hydroxy-5-(hydroxymethyl)-tetrahydrofuran-2-yl)-5-methylpyrimidine-2,4(1H,3H)-dione
1-(2-Deoxy-beta-D-ribofuranosyl)-5-methyluracil
1-(2-Deoxy-beta-L-erythro-pentofuranosyl)-5-methyl-2,4(1H,3H)-Pyrimidinedione
1-(2-Deoxy-beta-L-erythro-pentofuranosyl)-5-methylpyrimidine-2,4(1H,3H)-dione
1-(2-Deoxy-beta-L-erythropentafuranosyl)-5-methyl-2,4(1H,3H)-pyrimidinedione
1-(2-deoxy-beta-L-ribofuranosyl)-5-methyluracil
1-[(2S,4R,5S)-4-hydroxy-5-(hydroxymethyl)oxolan-2-yl]-5-methyl-1,2,3,4-tetrahydropyrimidine-2,4-dione
1-[(2s,4r,5s)-4-hydroxy-5-(hydroxymethyl)oxolan-2-yl]-5-methyl-pyrimidine-2,4-dione
1-[(2S,4R,5S)-4-hydroxy-5-(hydroxymethyl)oxolan-2-yl]-5-methylpyrimidine-2,4-dione
1-[(2S,4R,5S)-4-hydroxy-5-(hydroxymethyl)tetrahydrofuran-2-yl]-5-methyl-pyrimidine-2,4-dione
2-Deoxy-L-thymidine
2,4(1H,3H)-Pyrimidinedione, 1-(2-deoxy-b-L-erythro-pentofuranosyl)-5-methyl-
2'-Deoxy-L-thymidine
26879-47-0
2OC4HKD3SF
3424-98-4
5-Methyl-1-beta-L-ribofuranosyl-2,4 -pyrimidinedione
AB01274717_02
AB01274717-01
AB2000195
AC-5632
AC1L4LJI
AKOS025117349
AN-10762
API0025947
b-L-2'-deoxy-thymidine
BC257880
BDBM50088372
beta-L-2'-Deoxythymidine
beta-L-Thymidine
BRD-K15976406-001-01-7
CHEBI:63624
CHEMBL374731
CS-1934
CT-990
D06675
D0CL9S
DB01265
DTXSID30187813
Epavudine
GC4386
HY-B0017
I14-8810
IQFYYKKMVGJFEH-CSMHCCOUSA-N
KB-81600
L-Deoxythymidine
L-dT
L-Thymidine
LdT
LDT-600
LDT600
LLT
LS-186402
LS-187347
MFCD02683612
MolPort-006-167-757
NB 02B
NCGC00346560-01
NU000198
NU001074
NU001351
NU007768
NV 02B
NV-02B
s1651
SCHEMBL124279
Sebivo
Sebivo;Tyzeka
Telbivudin
Telbivudine (Sebivo, Tyzeka)
Telbivudine (USAN/INN)
Telbivudine [USAN:INN:BAN]
Telbivudine [USAN]
Telbivudine, >=98% (HPLC)
Telbivudine(Tyzeka, Sebivo)
Thymine, 1-(2-deoxy-.beta.-L-erythro-pentofuranosyl)-
Thymine, 1-(2-deoxy-beta-L-erythro-pentofuranosyl)-
Tyzake/Sebivo (TN)
Tyzeka
Tyzeka (TN)
Tyzeka, Sebivo, Telbivudine
UNII-2OC4HKD3SF
Z2574360267
ZB000493
ZINC2159

US Patents and Regulatory Information for telbivudine

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis TYZEKA telbivudine TABLET;ORAL 022011-001 Oct 25, 2006 DISCN Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Novartis TYZEKA telbivudine SOLUTION;ORAL 022154-001 Apr 28, 2009 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Novartis TYZEKA telbivudine SOLUTION;ORAL 022154-001 Apr 28, 2009 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Novartis TYZEKA telbivudine SOLUTION;ORAL 022154-001 Apr 28, 2009 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Novartis TYZEKA telbivudine TABLET;ORAL 022011-001 Oct 25, 2006 DISCN Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Novartis TYZEKA telbivudine TABLET;ORAL 022011-001 Oct 25, 2006 DISCN Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Novartis TYZEKA telbivudine TABLET;ORAL 022011-001 Oct 25, 2006 DISCN Yes No ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
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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Non-Orange Book US Patents for telbivudine

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
2,011,195,922 ➤ Sign Up
6,946,450 .beta.-L-2'-deoxy-nucleosides for the treatment of hepatitis B ➤ Sign Up
7,304,043 .beta.-L-2'-deoxy-nucleosides for the treatment of hepatitis B ➤ Sign Up
9,290,533 .beta.-L-2'-deoxy-nucleosides for the treatment of hepatitis B ➤ Sign Up
7,323,451 Crystalline and amorphous forms of beta-L-2'-deoxythymidine ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for telbivudine

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
348 Luxembourg ➤ Sign Up CERTIFICATE NAME: TELVIDUBINE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; FIRST REGISTRATION DATE: 20070424
1104436/01 Switzerland ➤ Sign Up FORMER OWNER: CENTRE NATIONAL DE LA RECHERCHE SCIENTIFIQUE, FR
C0046 France ➤ Sign Up PRODUCT NAME: TELBIVUDINE (DC1); REGISTRATION NO/DATE IN FRANCE: EU/1/07/388/001 DU 20070424; REGISTRATION NO/DATE AT EEC: EU/1/07/388/001 DU 20070424
39/2007 Austria ➤ Sign Up PRODUCT NAME: TELBIVUDIN
00286 Netherlands ➤ Sign Up PRODUCT NAME: TELBIVUDINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/07/388/001 20070424
07/027 Ireland ➤ Sign Up PRODUCT NAME: TELBIVUDINE AND THE PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/07/388/001 20070424
7 Finland ➤ Sign Up
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Baxter
Fuji
QuintilesIMS
Citi
Boehringer Ingelheim
Johnson and Johnson
Healthtrust
Cipla

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