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Last Updated: June 1, 2020

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CEPHULAC Drug Profile


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

Cephulac is a drug marketed by Sanofi Aventis Us and is included in one NDA.

The generic ingredient in CEPHULAC is lactulose. There are twenty drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the lactulose profile page.

US ANDA Litigation and Generic Entry Outlook for Cephulac

A generic version of CEPHULAC was approved as lactulose by HIKMA on May 29th, 1992.

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Summary for CEPHULAC
Drug patent expirations by year for CEPHULAC
Synonyms for CEPHULAC
(2S,3R,4S,5R,6R)-2-[(2R,3S,4S,5R)-4,5-dihydroxy-2,5-bis(hydroxymethyl)oxolan-3-yl]oxy-6-(hydroxymethyl)oxane-3,4,5-triol
(2S,3R,4S,5R,6R)-2-{[(2R,3S,4S,5R)-4,5-dihydroxy-2,5-bis(hydroxymethyl)oxolan-3-yl]oxy}-6-(hydroxymethyl)oxane-3,4,5-triol
2-[(3S,4S,2R,5R)-2,5-bis(hydroxymethyl)-4,5-dihydroxyoxolan-3-yloxy](2S,4S,3R, 5R,6R)-6-(hydroxymethyl)-2H-3,4,5,6-tetrahydropyran-3,4,5-triol
4-beta-D-Galactosido-(1,4)-D-fructose
4-O-b-D-galactopyranosyl-D-Fructofuranose
4-O-b-D-Galactopyranosyl-D-fructose
4-O-beta-D-galactopyranosyl-beta-D-fructofuranose
4-O-beta-D-Galactopyranosyl-D-fructofuranose
4-O-beta-D-Galactopyranosyl-D-fructose
4-O-beta-D-Galattopiranosil-D-fruttofuranosio
4-O-beta-D-Galattopiranosil-D-fruttofuranosio [Italian]
4-O-beta-delta-galactopyranosyl-delta-Fructofuranose
4-O-beta-delta-Galactopyranosyl-delta-fructose
5-17-07-00214 (Beilstein Handbook Reference)
58166-24-8
58166-25-9
9XH2P2N8EP
AB00052029_02
Acilac
Actilax
AKOS024283994
alpha-D-Fructofuranose, 4-o-beta-D-galactopyranosyl-
alpha-Lactulose
Amivalex
BDBM50377984
beta-D-Fructofuranose, 4-O-beta-D-galactopyranosyl-
Bifiteral
BRN 0093773
BRN 6278818
BSPBio_002216
C07064
C14H26O11
CAS-4618-18-2
CCG-39552
Cephulac (TN)
Cephulac Syrup
CHEBI:6359
CHEMBL296306
Cholac
Chronulac
Chronulac (TN)
Constilac
Constulose
D-Fructose, 4-O-beta-D-galactopyranosyl-
D-Lactulose
D00352
DB00581
delta-Lactulose
DivK1c_000064
DSSTox_CID_25833
DSSTox_GSID_45833
DSSTox_RID_81161
DTXSID5045833
Duphalac
EINECS 225-027-7
Enulose
Fructofuranose, 4-O-beta-D-galactopyranosyl-, D-
Generlac
Heptalac
HMS1920J03
HMS2094G15
HMS500D06
IDI1_000064
Isolactose
JCQLYHFGKNRPGE-FCVZTGTOSA-N
KBio1_000064
KBio2_001337
KBio2_003905
KBio2_006473
KBio3_001436
KBioGR_001303
KBioSS_001337
Kristalose
Lactulosa
Lactulosa [INN-Spanish]
Lactulosa [Spanish]
lactulose
Lactulose (JP17/USP/INN)
Lactulose [USAN:INN:BAN:JAN]
Lactulose [USAN:USP:INN:BAN:JAN]
Lactulose jp17
Lactulose Syrup
Lactulose(Enulose)
Lactulosum
Lactulosum [INN-Latin]
Lactulosum [Latin]
Laevolac
Lattulosio
Lattulosio [Italian]
Laxilose
LS-69750
LS-69751
NCGC00094707-01
NCGC00142624-01
NCGC00142624-02
NCGC00142624-03
NCGC00142624-05
NINDS_000064
Normase
NSC-757082
NSC757082
Pharmakon1600-01500363
Portalac
Q422689
SBB012563
SCHEMBL18912
SPBio_001117
Spectrum_000857
SPECTRUM1500363
Spectrum2_001159
Spectrum3_000478
Spectrum4_000962
Spectrum5_000908
SR-05000002084
SR-05000002084-1
SR-05000002084-4
ST072194
Tox21_111318
Tox21_111318_1
UNII-9U7D5QH5AE component JCQLYHFGKNRPGE-FCVZTGTOSA-N
UNII-9XH2P2N8EP
W9T
ZINC3977952
Paragraph IV (Patent) Challenges for CEPHULAC
Tradename Dosage Ingredient NDA Submissiondate
CEPHULAC SOLUTION;ORAL, RECTAL lactulose 017657

US Patents and Regulatory Information for CEPHULAC

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sanofi Aventis Us CEPHULAC lactulose SOLUTION;ORAL, RECTAL 017657-001 Approved Prior to Jan 1, 1982 DISCN Yes No   Start Trial   Start Trial   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 CEPHULAC

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us CEPHULAC lactulose SOLUTION;ORAL, RECTAL 017657-001 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Sanofi Aventis Us CEPHULAC lactulose SOLUTION;ORAL, RECTAL 017657-001 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Sanofi Aventis Us CEPHULAC lactulose SOLUTION;ORAL, RECTAL 017657-001 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Sanofi Aventis Us CEPHULAC lactulose SOLUTION;ORAL, RECTAL 017657-001 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Sanofi Aventis Us CEPHULAC lactulose SOLUTION;ORAL, RECTAL 017657-001 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Sanofi Aventis Us CEPHULAC lactulose SOLUTION;ORAL, RECTAL 017657-001 Approved Prior to Jan 1, 1982   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:

Harvard Business School
Mallinckrodt
McKinsey
Boehringer Ingelheim
Colorcon
Moodys

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