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Last Updated: November 23, 2024

BETAINE Drug Patent Profile


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Which patents cover Betaine, and when can generic versions of Betaine launch?

Betaine is a drug marketed by Eton and Novitium Pharma and is included in two NDAs.

The generic ingredient in BETAINE is betaine. There are five drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the betaine profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Betaine

A generic version of BETAINE was approved as betaine by NOVITIUM PHARMA on November 23rd, 2021.

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Drug patent expirations by year for BETAINE
Recent Clinical Trials for BETAINE

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SponsorPhase
University of IoanninaPhase 4
Assistance Publique - Hôpitaux de ParisPhase 2
University of North Carolina, Chapel HillPhase 1

See all BETAINE clinical trials

Pharmacology for BETAINE
Drug ClassMethylating Agent
Mechanism of ActionMethylating Activity

US Patents and Regulatory Information for BETAINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Eton BETAINE betaine FOR SOLUTION;ORAL 210508-001 Jan 28, 2022 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Novitium Pharma BETAINE betaine FOR SOLUTION;ORAL 214864-001 Nov 23, 2021 AB RX 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

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