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INGREZZA Drug Profile
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Which patents cover Ingrezza, and when can generic versions of Ingrezza launch?
Ingrezza is a drug marketed by Neurocrine and is included in one NDA. There are eight patents protecting this drug.
This drug has eighty-four patent family members in twenty-one countries.
The generic ingredient in INGREZZA is valbenazine tosylate. One supplier is listed for this compound. Additional details are available on the valbenazine tosylate profile page.
US ANDA Litigation and Generic Entry Outlook for Ingrezza
Ingrezza will be eligible for patent challenges on April 11, 2021. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be October 28, 2036. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for INGREZZA
| International Patents: | 84 |
| US Patents: | 8 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 27 |
| Patent Applications: | 73 |
| Drug Prices: | Drug price information for INGREZZA |
| What excipients (inactive ingredients) are in INGREZZA? | INGREZZA excipients list |
| DailyMed Link: | INGREZZA at DailyMed |
Generic Entry Opportunity Date for INGREZZA
Generic Entry Date for INGREZZA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
CAPSULE;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for INGREZZA
| Drug Class | Vesicular Monoamine Transporter 2 Inhibitor |
| Mechanism of Action | Vesicular Monoamine Transporter 2 Inhibitors |
US Patents and Regulatory Information for INGREZZA
| 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 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Neurocrine | INGREZZA | valbenazine tosylate | CAPSULE;ORAL | 209241-002 | Oct 4, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Neurocrine | INGREZZA | valbenazine tosylate | CAPSULE;ORAL | 209241-001 | Apr 11, 2017 | RX | Yes | No | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Neurocrine | INGREZZA | valbenazine tosylate | CAPSULE;ORAL | 209241-001 | Apr 11, 2017 | RX | Yes | No | Start Trial | 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 INGREZZA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| China | 110740732 | Start Trial |
| Poland | 2081929 | Start Trial |
| Cyprus | 1113838 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2018140094 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
