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: | 6 |
| 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
| Sponsor | Phase |
|---|---|
| Al-Azhar University | Phase 2 |
| Postgraduate Institute of Medical Education and Research | Phase 1 |
| Instituto de Investigación Hospital Universitario La Paz | Phase 2 |
Anatomical Therapeutic Chemical (ATC) Classes for lactitol
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Braintree Labs | PIZENSY | lactitol | FOR SOLUTION;ORAL | 211281-001 | Feb 12, 2020 | DISCN | Yes | 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 |
