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
Sponsor | Phase |
---|---|
University of Ioannina | Phase 4 |
Assistance Publique - Hôpitaux de Paris | Phase 2 |
University of North Carolina, Chapel Hill | Phase 1 |
Pharmacology for betaine
Drug Class | Methylating Agent |
Mechanism of Action | Methylating Activity |
Anatomical Therapeutic Chemical (ATC) Classes for betaine
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 | |||
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 | |||
>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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