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Last Updated: April 4, 2020

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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 freedom to operate?

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, Fresenius Kabi, Hi Tech Pharma, Hikma, Lannett Co Inc, Lifepharma, Morton Grove, Paco, Pharm Assoc, Torrent, Vistapharm, Wockhardt Bio Ag, Xttrium Labs Inc, Nostrum Labs, Bajaj, and Roxane, and is included in thirty-six NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty drug master file entries for lactulose. Fourteen suppliers are listed for this compound.

Drug Prices for lactulose

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Drug Sales Revenue Trends for lactulose

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Recent Clinical Trials for lactulose

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Postgraduate Institute of Medical Education and ResearchPhase 1
Leiden University Medical CenterPhase 4
Universitaire Ziekenhuizen LeuvenPhase 4

See all lactulose clinical trials

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
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
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: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 LACTULOSE
Tradename Dosage Ingredient NDA Submissiondate
CHRONULAC SOLUTION;ORAL lactulose 017884
CEPHULAC SOLUTION;ORAL, RECTAL lactulose 017657

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
Bajaj LACTULOSE lactulose SOLUTION;ORAL, RECTAL 076645-001 Jul 28, 2003 DISCN No No   Start Trial   Start Trial   Start Trial
Alra CONSTILAC lactulose SOLUTION;ORAL 071054-001 Jul 26, 1988 AA RX No No   Start Trial   Start Trial   Start Trial
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
Xttrium Labs Inc LACTULOSE lactulose SOLUTION;ORAL 075911-001 Feb 21, 2002 AA RX No No   Start Trial   Start Trial   Start Trial
Actavis Mid Atlantic ENULOSE lactulose SOLUTION;ORAL, RECTAL 071548-001 Aug 15, 1988 AA RX No Yes   Start Trial   Start Trial   Start Trial
Torrent LACTULOSE lactulose SOLUTION;ORAL, RECTAL 203762-001 Mar 27, 2015 DISCN No 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 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   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:

McKinsey
Mallinckrodt
Johnson and Johnson
Medtronic
McKesson
Boehringer Ingelheim

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 verification 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.