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Last Updated: March 28, 2024

Lactulose - Generic Drug Details


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What are the generic drug sources for lactulose and what is the scope of 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, Apozeal Pharms, Aurobindo Pharma Ltd, Chartwell Rx, Fresenius Kabi, Hikma, Lannett Co Inc, Morton Grove, Paco, Pharm Assoc, Vistapharm, Xttrium Labs Inc, Nostrum Labs, Wockhardt Bio Ag, Bajaj, Pai Holdings Pharm, 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. Eighteen 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
University of MichiganPhase 3
Patient-Centered Outcomes Research InstitutePhase 3
Khyber Medical College, PeshawarPhase 4

See all lactulose clinical trials

Pharmacology for lactulose
Medical Subject Heading (MeSH) Categories for lactulose

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
Apozeal Pharms LACTULOSE lactulose SOLUTION;ORAL, RECTAL 203762-001 Mar 27, 2015 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Morton Grove GENERLAC lactulose SOLUTION;ORAL, RECTAL 071842-001 Sep 27, 1988 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Teva Pharms HEPTALAC lactulose SOLUTION;ORAL, RECTAL 073504-001 May 28, 1993 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Xttrium Labs Inc LACTULOSE lactulose SOLUTION;ORAL 075911-001 Feb 21, 2002 AA RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sanofi Aventis Us CEPHULAC lactulose SOLUTION;ORAL, RECTAL 017657-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Solvay DUPHALAC lactulose SOLUTION;ORAL 072372-001 Mar 22, 1989 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Nostrum Labs LAXILOSE lactulose SOLUTION;ORAL 073686-001 May 28, 1993 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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 ⤷  Try a Trial ⤷  Try a Trial
Sanofi Aventis Us CEPHULAC lactulose SOLUTION;ORAL, RECTAL 017657-001 Approved Prior to Jan 1, 1982 ⤷  Try a Trial ⤷  Try a Trial
Sanofi Aventis Us CEPHULAC lactulose SOLUTION;ORAL, RECTAL 017657-001 Approved Prior to Jan 1, 1982 ⤷  Try a Trial ⤷  Try a Trial
Sanofi Aventis Us CEPHULAC lactulose SOLUTION;ORAL, RECTAL 017657-001 Approved Prior to Jan 1, 1982 ⤷  Try a Trial ⤷  Try a Trial
Sanofi Aventis Us CEPHULAC lactulose SOLUTION;ORAL, RECTAL 017657-001 Approved Prior to Jan 1, 1982 ⤷  Try a Trial ⤷  Try a Trial
Sanofi Aventis Us CEPHULAC lactulose SOLUTION;ORAL, RECTAL 017657-001 Approved Prior to Jan 1, 1982 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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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.