BETAINE - Generic Drug Details

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What are the generic 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

Sponsor	Phase
University of Ioannina	Phase 4
Assistance Publique - Hôpitaux de Paris	Phase 2
University of North Carolina, Chapel Hill	Phase 1

See all BETAINE clinical trials

Pharmacology for BETAINE

Drug Class	Methylating Agent
Mechanism of Action	Methylating Activity

Anatomical Therapeutic Chemical (ATC) Classes for BETAINE

A16AA	Amino acids and derivatives
A16A	OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
A16	OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
A	Alimentary tract and metabolism

US Patents and Regulatory Information for BETAINE

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Glossary

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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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