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. Four 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.
Summary for BETAINE
| US Patents: | 0 |
| Applicants: | 2 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 3 |
| Raw Ingredient (Bulk) Api Vendors: | 129 |
| Clinical Trials: | 25 |
| Patent Applications: | 117 |
| Formulation / Manufacturing: | see details |
| 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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Novitium Pharma | BETAINE | betaine | FOR SOLUTION;ORAL | 214864-001 | Nov 23, 2021 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
