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, 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. Seventeen suppliers are listed for this compound.
Summary for LACTULOSE
| US Patents: | 0 |
| Tradenames: | 14 |
| Applicants: | 22 |
| NDAs: | 36 |
| Drug Master File Entries: | 20 |
| Finished Product Suppliers / Packagers: | 17 |
| Raw Ingredient (Bulk) Api Vendors: | 28 |
| Clinical Trials: | 149 |
| Patent Applications: | 6,881 |
| 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 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Aurobindo Pharma Ltd | LACTULOSE | lactulose | SOLUTION;ORAL | 074602-001 | Nov 14, 1996 | 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 | |||
| Solvay | DUPHALAC | lactulose | SOLUTION;ORAL | 072372-001 | Mar 22, 1989 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Ani Pharms | LACTULOSE | lactulose | SOLUTION;ORAL | 078430-001 | Nov 28, 2007 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Cumberland Pharms | LACTULOSE | lactulose | FOR SOLUTION;ORAL | 074712-002 | Dec 10, 1997 | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Vistapharm | LACTULOSE | lactulose | SOLUTION;ORAL | 074138-001 | Sep 30, 1992 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Nostrum Labs | ACILAC | lactulose | SOLUTION;ORAL, RECTAL | 073685-001 | 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
| 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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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.
ISSN: 2162-2639
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