LACTULOSE Drug Patent Profile
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Which patents cover Lactulose, and when can generic versions of Lactulose launch?
Lactulose is a drug marketed by Cumberland 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, Bajaj, Pai Holdings Pharm, 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. Eighteen suppliers are listed for this compound. Additional details are available on the lactulose profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Lactulose
A generic version of LACTULOSE was approved as lactulose by PHARM ASSOC on July 30th, 1996.
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for LACTULOSE?
- What are the global sales for LACTULOSE?
- What is Average Wholesale Price for LACTULOSE?
Summary for LACTULOSE
| US Patents: | 0 |
| Applicants: | 17 |
| NDAs: | 22 |
| Finished Product Suppliers / Packagers: | 18 |
| Raw Ingredient (Bulk) Api Vendors: | 28 |
| Clinical Trials: | 149 |
| Patent Applications: | 3,582 |
| Drug Prices: | Drug price information for LACTULOSE |
| Drug Sales Revenues: | Drug sales revenues for LACTULOSE |
| DailyMed Link: | LACTULOSE at DailyMed |
Recent Clinical Trials for LACTULOSE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Project Peanut Butter | N/A |
| Washington University School of Medicine | N/A |
| Ministry of Health and Sanitation, Sierra Leone | N/A |
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
Anatomical Therapeutic Chemical (ATC) Classes 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Cumberland Pharms | LACTULOSE | lactulose | FOR SOLUTION;ORAL | 074712-001 | Dec 10, 1997 | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Bajaj | LACTULOSE | lactulose | SOLUTION;ORAL, RECTAL | 076645-001 | Jul 28, 2003 | AA | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Fresenius Kabi | LACTULOSE | lactulose | SOLUTION;ORAL | 090503-001 | Jan 25, 2012 | AA | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Apozeal Pharms | LACTULOSE | lactulose | SOLUTION;ORAL | 207786-001 | Jun 11, 2018 | AA | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Paco | LACTULOSE | lactulose | SOLUTION;ORAL | 073160-001 | Aug 25, 1992 | DISCN | No | No | ⤷ 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 | ||||
| Hikma | LACTULOSE | lactulose | SOLUTION;ORAL | 073591-001 | May 29, 1992 | 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 |
