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Last Updated: August 15, 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
Aga Khan UniversityPhase 4
Postgraduate Institute of Medical Education and ResearchPhase 1
Maastricht University Medical CenterPhase 4

See all lactulose clinical trials

Pharmacology for lactulose
Medical Subject Heading (MeSH) Categories for lactulose
Paragraph IV (Patent) Challenges for LACTULOSE
Tradename Dosage Ingredient NDA Submissiondate
CEPHULAC SOLUTION;ORAL, RECTAL lactulose 017657
CHRONULAC SOLUTION;ORAL lactulose 017884

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
Torrent LACTULOSE lactulose SOLUTION;ORAL, RECTAL 203762-001 Mar 27, 2015 DISCN No No   Start Trial   Start Trial   Start Trial
Hi Tech Pharma LACTULOSE lactulose SOLUTION;ORAL, RECTAL 074077-001 Jul 3, 1995 AA RX No No   Start Trial   Start Trial   Start Trial
Alra CHOLAC lactulose SOLUTION;ORAL, RECTAL 071331-001 Jul 26, 1988 AA RX No No   Start Trial   Start Trial   Start Trial
Vistapharm LACTULOSE lactulose SOLUTION;ORAL 074138-001 Sep 30, 1992 AA RX No No   Start Trial   Start Trial   Start Trial
Fresenius Kabi LACTULOSE lactulose SOLUTION;ORAL, RECTAL 090502-001 Jan 25, 2012 AA RX No No   Start Trial   Start Trial   Start Trial
Bajaj LACTULOSE lactulose SOLUTION;ORAL, RECTAL 076645-001 Jul 28, 2003 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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