Ingrezza Sprinkle is a drug owned by Neurocrine Biosciences Inc. It is protected by 22 US drug patents filed in 2024 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Aug 10, 2040. Details of Ingrezza Sprinkle's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance. | |||
| US8039627 | Substituted 3-isobutyl-9,10-dimethoxy-1,3,4,6,7,11b-hexahydro-2H-pyrido[2,1-A]isoquinolin-2-ol compounds and methods relating thereto |
Apr, 2031
(6 years from now) | Active |
| US10844058 | Valbenazine salts and polymorphs thereof |
Oct, 2036
(12 years from now) | Active |
| US10065952 | Valbenazine salts and polymorphs thereof |
Oct, 2036
(12 years from now) | Active |
| US10851104 | Valbenazine salts and polymorphs thereof |
Oct, 2036
(12 years from now) | Active |
| US10851103 | Valbenazine salts and polymorphs thereof |
Oct, 2036
(12 years from now) | Active |
| US10919892 | Synthetic methods for preparation of (S)-(2R,3R,11bR)-3-isobutyl-9,10-dimethoxy-2,3,4,6,7,11b-hexahydro-1H-pyrido[2,1-a]isoquinolin-2-yl 2-amino-3-methylbutanoate di(4-methylbenzenesulfonate) |
Dec, 2036
(12 years from now) | Active |
| US10906903 | Synthetic methods for preparation of (S)-(2R,3R,11bR)-3-isobutyl-9,10-dimethoxy-2,3,4,6,7,11b-hexahydro-1H-pyrido[2,1,-a]isoquinolin-2-yl 2-amino-3-methylbutanoate di(4-methylbenzenesulfonate) |
Dec, 2036
(12 years from now) | Active |
| US10906902 | Synthetic methods for preparation of (S)-(2R,3R,11bR)-3-isobutyl-9,10-dimethoxy-2,3,4,6,7,11b-hexahydro-1H-pyrido[2,1,-a]isoquinolin-2-2-amino-3-methylbutanoate di(4-methylbenzenesulfonate) |
Dec, 2036
(12 years from now) | Active |
| These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US8357697 | Substituted 3-isobutyl-9,10-dimethoxy-1,3,4,6,7,11b-hexahydro-2H-pyrido[2,1-A]isoquinolin-2-ol compounds and methods relating thereto |
Nov, 2027
(3 years from now) | Active |
| US10912771 | Methods for the administration of certain VMAT2 inhibitors |
Oct, 2037
(13 years from now) | Active |
| US11439629 | Methods for the administration of certain VMAT2 inhibitors |
Oct, 2037
(13 years from now) | Active |
| US11040029 | Methods for the administration of certain VMAT2 inhibitors |
Oct, 2037
(13 years from now) | Active |
| US10993941 | Methods for the administration of certain VMAT2 inhibitors |
Oct, 2037
(13 years from now) | Active |
| US10952997 | Methods for the administration of certain VMAT2 inhibitors |
Oct, 2037
(13 years from now) | Active |
| US10874648 | Methods for the administration of certain VMAT2 inhibitors |
Oct, 2037
(13 years from now) | Active |
| US10857148 | Methods for the administration of certain VMAT2 inhibitors |
Oct, 2037
(13 years from now) | Active |
| US10857137 | Methods for the administration of certain VMAT2 inhibitors |
Oct, 2037
(13 years from now) | Active |
| US11311532 | High dosage valbenazine formulation and compositions, methods, and kits related thereto |
Sep, 2038
(14 years from now) | Active |
| US11026939 | High dosage valbenazine formulation and compositions, methods, and kits related thereto |
Sep, 2038
(14 years from now) | Active |
| US11654142 | Methods for the administration of certain VMAT2 inhibitors |
Nov, 2038
(14 years from now) | Active |
| US11026931 | Methods for the administration of certain VMAT2 inhibitors |
Aug, 2039
(14 years from now) | Active |
| US10940141 | Methods for the administration of certain VMAT2 inhibitors |
Aug, 2040
(15 years from now) | Active |
FDA has granted several exclusivities to Ingrezza Sprinkle. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Ingrezza Sprinkle, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Ingrezza Sprinkle.
Exclusivity Information
Ingrezza Sprinkle holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2026. Details of Ingrezza Sprinkle's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Indication(I-925) | Aug 18, 2026 |
US patents provide insights into the exclusivity only within the United States, but Ingrezza Sprinkle is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Ingrezza Sprinkle's family patents as well as insights into ongoing legal events on those patents.
Ingrezza Sprinkle's Family Patents
Try Our Curated Drug Screens
Generic Launch
Generic Release Date:
Ingrezza Sprinkle's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Aug 10, 2040 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Ingrezza Sprinkle Generics:
Valbenazine Tosylate is the generic name for the brand Ingrezza Sprinkle. 2 different companies have already filed for the generic of Ingrezza Sprinkle, with Zydus having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Ingrezza Sprinkle's generic
Ingrezza Sprinkle Competitors
Understanding your competition is essential for market success. There are several other brand drugs in the same treatment category and using the same active ingredient (Valbenazine Tosylate) as Ingrezza Sprinkle. Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | Treatment Area | ||
|---|---|---|---|---|
| Neurocrine |
| |||
| Teva |
| |||
| Teva Branded Pharm |
| |||
Apart from brand drugs containing the same ingredient, some generics have also been filed for Valbenazine Tosylate, Ingrezza Sprinkle's active ingredient. Check the complete list of approved generic manufacturers for Ingrezza Sprinkle
About Ingrezza Sprinkle
Ingrezza Sprinkle is a drug owned by Neurocrine Biosciences Inc. Ingrezza Sprinkle uses Valbenazine Tosylate as an active ingredient. Ingrezza Sprinkle was launched by Neurocrine in 2024.
Approval Date:
Ingrezza Sprinkle was approved by FDA for market use on 30 April, 2024.
Active Ingredient:
Ingrezza Sprinkle uses Valbenazine Tosylate as the active ingredient. Check out other Drugs and Companies using Valbenazine Tosylate ingredient
Dosage:
Ingrezza Sprinkle is available in capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 40MG BASE | CAPSULE | Prescription | ORAL |
| EQ 80MG BASE | CAPSULE | Prescription | ORAL |
| EQ 60MG BASE | CAPSULE | Prescription | ORAL |