VALBENAZINE TOSYLATE Drug Patent Profile
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When do Valbenazine Tosylate patents expire, and what generic alternatives are available?
Valbenazine Tosylate is a drug marketed by Lupin and Zydus Lifesciences and is included in two NDAs.
The generic ingredient in VALBENAZINE TOSYLATE is valbenazine tosylate. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the valbenazine tosylate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Valbenazine Tosylate
A generic version of VALBENAZINE TOSYLATE was approved as valbenazine tosylate by LUPIN on April 5th, 2024.
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Questions you can ask:
- What is the 5 year forecast for VALBENAZINE TOSYLATE?
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- What is Average Wholesale Price for VALBENAZINE TOSYLATE?
Summary for VALBENAZINE TOSYLATE
| US Patents: | 0 |
| Applicants: | 2 |
| NDAs: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 27 |
| Patent Applications: | 61 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for VALBENAZINE TOSYLATE |
| DailyMed Link: | VALBENAZINE TOSYLATE at DailyMed |
Anatomical Therapeutic Chemical (ATC) Classes for VALBENAZINE TOSYLATE
Paragraph IV (Patent) Challenges for VALBENAZINE TOSYLATE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| INGREZZA SPRINKLE | Capsules | valbenazine tosylate | 40 mg, 60 mg and 80 mg | 218390 | 1 | 2025-01-07 |
| INGREZZA | Capsules | valbenazine tosylate | 60 mg | 209241 | 1 | 2022-02-14 |
| INGREZZA | Capsules | valbenazine tosylate | 40 mg and 80 mg | 209241 | 4 | 2021-04-12 |
US Patents and Regulatory Information for VALBENAZINE TOSYLATE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Lupin | VALBENAZINE TOSYLATE | valbenazine tosylate | CAPSULE;ORAL | 216064-001 | Apr 5, 2024 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Zydus Lifesciences | VALBENAZINE TOSYLATE | valbenazine tosylate | CAPSULE;ORAL | 216137-002 | Aug 7, 2024 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Lupin | VALBENAZINE TOSYLATE | valbenazine tosylate | CAPSULE;ORAL | 216064-002 | Apr 5, 2024 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
