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Last Updated: April 26, 2024

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. Nineteen 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:	19
Raw Ingredient (Bulk) Api Vendors:	28
Clinical Trials:	147
Patent Applications:	6,476
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
Patient-Centered Outcomes Research Institute	Phase 3
University of Michigan	Phase 3
Khyber Medical College, Peshawar	Phase 4

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

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
Teva Pharms	HEPTALAC	lactulose	SOLUTION;ORAL, RECTAL	073504-001	May 28, 1993		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Cumberland Pharms	LACTULOSE	lactulose	FOR SOLUTION;ORAL	074712-001	Dec 10, 1997		RX	No	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Fresenius Kabi	LACTULOSE	lactulose	SOLUTION;ORAL	090503-001	Jan 25, 2012	AA	RX	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
Hikma	LACTULOSE	lactulose	SOLUTION;ORAL	074076-001	Jul 3, 1995	AA	RX	No	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Lannett Co Inc	LACTULOSE	lactulose	SOLUTION;ORAL	075993-001	Jul 26, 2001	AA	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Actavis Mid Atlantic	ENULOSE	lactulose	SOLUTION;ORAL, RECTAL	071548-001	Aug 15, 1988		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

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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	⤷ 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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