Valbenazine tosylate - Generic Drug Details
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What are the generic drug sources for valbenazine tosylate and what is the scope of patent protection?
Valbenazine tosylate
is the generic ingredient in three branded drugs marketed by Neurocrine, Lupin, and Zydus Lifesciences, and is included in four NDAs. There are twenty-two patents protecting this compound. Additional information is available in the individual branded drug profile pages.Valbenazine tosylate has two hundred and seventy-seven patent family members in thirty-seven countries.
One supplier is listed for this compound. There are two tentative approvals for this compound.
Summary for valbenazine tosylate
| International Patents: | 277 |
| US Patents: | 22 |
| Tradenames: | 3 |
| Applicants: | 3 |
| NDAs: | 4 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 27 |
| Patent Applications: | 71 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for valbenazine tosylate |
| DailyMed Link: | valbenazine tosylate at DailyMed |
Generic filers with tentative approvals for VALBENAZINE TOSYLATE
| Applicant | Application No. | Strength | Dosage Form |
| ⤷ Start Trial | ⤷ Start Trial | 80MG | CAPSULE;ORAL |
| ⤷ Start Trial | ⤷ Start Trial | 40MG | CAPSULE;ORAL |
| ⤷ Start Trial | ⤷ Start Trial | EQ 60MG BASE | CAPSULE;ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for valbenazine tosylate
| Drug Class | Vesicular Monoamine Transporter 2 Inhibitor |
| Mechanism of Action | Vesicular Monoamine Transporter 2 Inhibitors |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Neurocrine | INGREZZA | valbenazine tosylate | CAPSULE;ORAL | 209241-001 | Apr 11, 2017 | AB | RX | Yes | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Neurocrine | INGREZZA SPRINKLE | valbenazine tosylate | CAPSULE;ORAL | 218390-003 | Apr 30, 2024 | RX | Yes | Yes | 10,993,941 | ⤷ Start Trial | ⤷ Start Trial | ||||
| Neurocrine | INGREZZA SPRINKLE | valbenazine tosylate | CAPSULE;ORAL | 218390-002 | Apr 30, 2024 | RX | Yes | No | 10,857,137 | ⤷ Start Trial | ⤷ Start Trial | ||||
| Neurocrine | INGREZZA | valbenazine tosylate | CAPSULE;ORAL | 209241-002 | Oct 4, 2017 | AB | RX | Yes | Yes | 10,906,902 | ⤷ Start Trial | Y | Y | ⤷ Start Trial | |
| Neurocrine | INGREZZA | valbenazine tosylate | CAPSULE;ORAL | 209241-002 | Oct 4, 2017 | AB | RX | Yes | Yes | 10,912,771 | ⤷ Start Trial | ⤷ Start Trial | |||
| Neurocrine | INGREZZA SPRINKLE | valbenazine tosylate | CAPSULE;ORAL | 218390-002 | Apr 30, 2024 | RX | Yes | No | 10,065,952 | ⤷ Start Trial | Y | Y | ⤷ Start Trial | ||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for valbenazine tosylate
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Australia | 2016343633 | ⤷ Start Trial | |
| Brazil | 112018008460 | ⤷ Start Trial | |
| Canada | 3002074 | ⤷ Start Trial | |
| Chile | 2018001089 | ⤷ Start Trial | |
| China | 108473489 | ⤷ Start Trial | |
| China | 115304596 | ⤷ Start Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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