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Last Updated: November 23, 2024

Betaine - Generic Drug Details


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

Betaine is the generic ingredient in two branded drugs marketed by Eton, Novitium Pharma, and Recordati Rare, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.

There are five drug master file entries for betaine. Three suppliers are listed for this compound.

Summary for betaine
US Patents:0
Tradenames:2
Applicants:3
NDAs:3
Drug Master File Entries: 5
Finished Product Suppliers / Packagers: 3
Raw Ingredient (Bulk) Api Vendors: 129
Clinical Trials: 25
Patent Applications: 6,376
What excipients (inactive ingredients) are in betaine?betaine excipients list
DailyMed Link:betaine at DailyMed
Recent Clinical Trials for betaine

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

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
Recordati Rare CYSTADANE betaine FOR SOLUTION;ORAL 020576-001 Oct 25, 1996 AB RX Yes Yes ⤷  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
Eton BETAINE betaine FOR SOLUTION;ORAL 210508-001 Jan 28, 2022 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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