➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

AstraZeneca
Harvard Business School
Express Scripts
Medtronic
Johnson and Johnson
Dow

Last Updated: July 6, 2020

DrugPatentWatch Database Preview

LACTULOSE Drug Profile


Email this page to a colleague

» See Plans and Pricing

« Back to Dashboard

Which patents cover Lactulose, and when can generic versions of Lactulose launch?

Lactulose is a drug marketed by Cumberland 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, Bajaj, Roxane, and Solvay. and is included in twenty-two NDAs.

The generic ingredient in LACTULOSE 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 Lactulose

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

  Start Trial

Drug patent expirations by year for LACTULOSE
Drug Prices for LACTULOSE

See drug prices for LACTULOSE

Drug Sales Revenue Trends for LACTULOSE

See drug sales revenues for LACTULOSE

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
Cumberland Pharms LACTULOSE lactulose FOR SOLUTION;ORAL 074712-001 Dec 10, 1997 RX No Yes   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
Lannett Co Inc LACTULOSE lactulose SOLUTION;ORAL 075993-001 Jul 26, 2001 AA RX No No   Start Trial   Start Trial   Start Trial
Fresenius Kabi LACTULOSE lactulose SOLUTION;ORAL 090503-001 Jan 25, 2012 AA RX No No   Start Trial   Start Trial   Start Trial
Torrent LACTULOSE lactulose SOLUTION;ORAL 207786-001 Jun 11, 2018 DISCN No No   Start Trial   Start Trial   Start Trial
Paco LACTULOSE lactulose SOLUTION;ORAL, RECTAL 072029-001 Aug 25, 1992 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

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

AstraZeneca
Harvard Business School
Express Scripts
Medtronic
Johnson and Johnson
Dow

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.