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Generated: November 20, 2018

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Lactulose - Generic Drug Details

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

Lactulose is the generic ingredient in fourteen branded drugs marketed by Cumberland Pharms, Sanofi Aventis Us, Alra, Actavis Mid Atlantic, Solvay, Teva Pharms, Ani Pharms, Apotex Inc, Bio-pharm Inc, Fresenius Kabi, Hi Tech Pharma, Lannett Co Inc, Morton Grove, Paco, Pharm Assoc, Vistapharm, West-ward Pharms Int, Wockhardt Bio Ag, Nostrum Labs, and Roxane, and is included in thirty-five NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty drug master file entries for lactulose. Twenty-one suppliers are listed for this compound.

Pharmacology for lactulose
Medical Subject Heading (MeSH) Categories for lactulose
Synonyms for lactulose
(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
29319-45-7
33980-82-4
4-b-d-galactosido-d-fructose
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
40773-84-0
4618-18-2
5-17-07-00214 (Beilstein Handbook Reference)
576-08-9
58166-24-8
58166-25-9
9XH2P2N8EP
AB00052029_02
AC1L1X4S
AC1Q59TY
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
CA001452
CA009966
CAS-4618-18-2
CCG-39552
Cephulac
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 (JP17/USP/INN)
Lactulose [USAN:BAN:INN:JAN]
Lactulose [USAN:INN:BAN:JAN]
Lactulose Syrup
Lactulose, ~98%
Lactulosum
Lactulosum [INN-Latin]
Lactulosum [Latin]
Laevolac
Lattulosio
Lattulosio [Italian]
Laxilose
LS-69750
LS-69751
MolPort-003-666-217
NCGC00094707-01
NCGC00142624-01
NCGC00142624-02
NCGC00142624-03
NCGC00142624-05
NINDS_000064
Normase
NSC-757082
NSC757082
Pharmakon1600-01500363
Portalac
SBB012563
SCHEMBL18912
SPBio_001117
Spectrum_000857
SPECTRUM1500363
Spectrum2_001159
Spectrum3_000478
Spectrum4_000962
Spectrum5_000908
SR-05000002084
SR-05000002084-4
ST072194
Tox21_111318
Tox21_111318_1
UNII-9U7D5QH5AE component JCQLYHFGKNRPGE-FCVZTGTOSA-N
UNII-9XH2P2N8EP
W9T
ZINC3977952

US Patents and Regulatory Information for lactulose

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Alra CHOLAC lactulose SOLUTION;ORAL, RECTAL 071331-001 Jul 26, 1988 AA RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Morton Grove GENERLAC lactulose SOLUTION;ORAL, RECTAL 071842-001 Sep 27, 1988 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Actavis Mid Atlantic CONSTULOSE lactulose SOLUTION;ORAL 070288-001 Aug 15, 1988 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Sanofi Aventis Us CEPHULAC lactulose SOLUTION;ORAL, RECTAL 017657-001 Approved Prior to Jan 1, 1982 DISCN Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Paco LACTULOSE lactulose SOLUTION;ORAL 073160-001 Aug 25, 1992 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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Expired US Patents for lactulose

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

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Serving hundreds of leading biopharmaceutical companies globally:

Fuji
Argus Health
Dow
US Army
Citi
Farmers Insurance
Cipla
Merck
Express Scripts

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