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, 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. Twenty suppliers are listed for this compound.

Summary for lactulose

US Patents:	0
Tradenames:	14
Applicants:	23
NDAs:	36
Drug Master File Entries:	20
Finished Product Suppliers / Packagers:	20
Raw Ingredient (Bulk) Api Vendors:	28
Clinical Trials:	149
Patent Applications:	6,875
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for lactulose
Drug Sales Revenues:	Drug sales revenues for lactulose
What excipients (inactive ingredients) are in lactulose?	lactulose excipients list
DailyMed Link:	lactulose at DailyMed

See drug prices for lactulose

See drug sales revenues for lactulose

Recent Clinical Trials for lactulose

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

Sponsor	Phase
Thrasher Research Fund	N/A
Project Peanut Butter	N/A
Washington University School of Medicine	N/A

See all lactulose clinical trials

Pharmacology for lactulose

Drug Class	Osmotic Laxative
Mechanism of Action	Acidifying Activity Osmotic Activity
Physiological Effect	Stimulation Large Intestine Fluid/Electrolyte Secretion

Medical Subject Heading (MeSH) Categories for lactulose

Gastrointestinal Agents

Anatomical Therapeutic Chemical (ATC) Classes for lactulose

A06AD	Osmotically acting laxatives
A06A	DRUGS FOR CONSTIPATION
A06	DRUGS FOR CONSTIPATION
A	Alimentary tract and metabolism

US Patents and Regulatory Information for lactulose

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Glossary

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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	074712-002	Dec 10, 1997		RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Paco	LACTULOSE	lactulose	SOLUTION;ORAL, RECTAL	072029-001	Aug 25, 1992		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Fresenius Kabi	LACTULOSE	lactulose	SOLUTION;ORAL, RECTAL	090502-001	Jan 25, 2012	AA	RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Chartwell Rx	LACTULOSE	lactulose	SOLUTION;ORAL	209517-001	Nov 23, 2018	AA	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Pharm Assoc	LACTULOSE	lactulose	SOLUTION;ORAL	074623-001	Jul 30, 1996	AA	RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Teva Pharms	EVALOSE	lactulose	SOLUTION;ORAL	073497-001	May 28, 1993		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

Expired US Patents for lactulose

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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
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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