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Last Updated: April 17, 2024

Lactitol - Generic Drug Details


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What are the generic sources for lactitol and what is the scope of patent protection?

Lactitol is the generic ingredient in one branded drug marketed by Braintree Labs and is included in one NDA. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

There are four drug master file entries for lactitol.

Summary for lactitol
US Patents:1
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 4
Raw Ingredient (Bulk) Api Vendors: 51
Clinical Trials: 5
Patent Applications: 3,947
What excipients (inactive ingredients) are in lactitol?lactitol excipients list
DailyMed Link:lactitol at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for lactitol
Generic Entry Date for lactitol*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY
Dosage:
FOR SOLUTION;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for lactitol

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

SponsorPhase
Postgraduate Institute of Medical Education and ResearchPhase 1
Instituto de Investigación Hospital Universitario La PazPhase 2
Dayanand Medical College and HospitalPhase 4

See all lactitol clinical trials

US Patents and Regulatory Information for lactitol

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Braintree Labs PIZENSY lactitol FOR SOLUTION;ORAL 211281-001 Feb 12, 2020 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Braintree Labs PIZENSY lactitol FOR SOLUTION;ORAL 211281-001 Feb 12, 2020 DISCN Yes 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

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

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.