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Generated: September 23, 2018

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TYZEKA Drug Profile

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When do Tyzeka patents expire, and what generic alternatives are available?

Tyzeka is a drug marketed by Novartis and is included in two NDAs. There are seven patents protecting this drug.

The generic ingredient in TYZEKA is telbivudine. There are two drug master file entries for this compound. Additional details are available on the telbivudine profile page.

Summary for TYZEKA
Drug patent expirations by year for TYZEKA
Generic Entry Opportunity Date for TYZEKA
Generic Entry Dates for TYZEKA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SOLUTION;ORAL
Generic Entry Dates for TYZEKA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Synonyms for TYZEKA
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
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 (TN)
Tyzeka, Sebivo, Telbivudine
UNII-2OC4HKD3SF
Z2574360267
ZB000493
ZINC2159

US Patents and Regulatory Information for TYZEKA

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 ➤ 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 SOLUTION;ORAL 022154-001 Apr 28, 2009 DISCN No No ➤ Sign Up ➤ Sign Up ➤ 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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Supplementary Protection Certificates for TYZEKA

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
C/GB07/058 United Kingdom ➤ Sign Up 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:

Queensland Health
Colorcon
Argus Health
Teva
Chinese Patent Office
Mallinckrodt
McKinsey
Cipla
Farmers Insurance

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