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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Argus Health
AstraZeneca
QuintilesIMS
Cantor Fitzgerald
UBS
Cerilliant
Covington
Deloitte

Generated: October 22, 2018

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Telbivudine - Generic Drug Details

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

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.

There are two drug master file entries for telbivudine.

Summary for telbivudine
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 SOLUTION;ORAL 022154-001 Apr 28, 2009 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Novartis TYZEKA telbivudine TABLET;ORAL 022011-001 Oct 25, 2006 DISCN Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Novartis TYZEKA telbivudine SOLUTION;ORAL 022154-001 Apr 28, 2009 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Novartis TYZEKA telbivudine TABLET;ORAL 022011-001 Oct 25, 2006 DISCN Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Novartis TYZEKA telbivudine SOLUTION;ORAL 022154-001 Apr 28, 2009 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Novartis TYZEKA telbivudine TABLET;ORAL 022011-001 Oct 25, 2006 DISCN Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y 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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Supplementary Protection Certificates for telbivudine

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
07C0046 France ➤ Try a Free Trial
1104436/01 Switzerland ➤ Try a Free Trial FORMER OWNER: CENTRE NATIONAL DE LA RECHERCHE SCIENTIFIQUE, FR
/2007 Austria ➤ Try a Free Trial PRODUCT NAME: TELBIVUDIN; REGISTRATION NO/DATE: EU/1/07/388/001 20070424
348 Luxembourg ➤ Try a Free Trial CERTIFICATE NAME: TELVIDUBINE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; FIRST REGISTRATION DATE: 20070424
00286 Netherlands ➤ Try a Free Trial PRODUCT NAME: TELBIVUDINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/07/388/001 20070424
C/GB07/058 United Kingdom ➤ Try a Free Trial SUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB07/058 GRANTED TO NOVARTIS AG, CENTRE NATIONAL DE LA RECHERCHE SCIENTIFIQUE AND L UNIVERSITE MONTPELLIER II IN RESPECT OF THE PRODUCT TELBIVUDINE AND THE PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, THE GRANT OF WHICH WAS ADVERTISED IN JOURNAL NO 6311 DATED 05 MAY 2010 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, SUBJECT TO THE PAYMENT OF THE PRESCRIBED FEES IT WILL EXPIRE ON 25 APRIL 2022.
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Argus Health
AstraZeneca
QuintilesIMS
Cantor Fitzgerald
UBS
Cerilliant
Covington
Deloitte

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.