Generic Ingrezza Availability
Last updated on Apr 10, 2025.
See also: Generic Ingrezza Sprinkle
Ingrezza is a brand name of valbenazine, approved by the FDA in the following formulation(s):
INGREZZA (valbenazine tosylate - capsule;oral)
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Manufacturer: NEUROCRINE
Approval date: April 11, 2017
Strength(s): EQ 40MG BASE [RLD] [AB] -
Manufacturer: NEUROCRINE
Approval date: October 4, 2017
Strength(s): EQ 80MG BASE [RLD] [AB] -
Manufacturer: NEUROCRINE
Approval date: April 23, 2021
Strength(s): EQ 60MG BASE [RLD]
Is there a generic version of Ingrezza available?
A generic version of Ingrezza has been approved by the FDA. However, this does not mean that the product will necessarily be commercially available - possibly because of drug patents and/or drug exclusivity. The following products are equivalent to Ingrezza and have been approved by the FDA:
valbenazine tosylate capsule;oral
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Manufacturer: LUPIN LTD
Approval date: April 5, 2024
Strength(s): EQ 40MG BASE [AB], EQ 80MG BASE [AB]
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Ingrezza. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.
See also: Generic Drug FAQ.
Related patents
Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.
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Valbenazine salts and polymorphs thereof
Patent 10,065,952
Issued: September 4, 2018
Inventor(s): McGee Kevin & Zook Scott & Carr Andrew & Bonnaud Thierry
Assignee(s): Neurocrine Biosciences, Inc.Provided herein are salts of (S)-2-amino-3-methyl-butyric acid (2R,3R,11bR)-3-isobutyl-9,10-dimethoxy-1,3,4,6,7,11b-hexahydro-2H-pyrido[2,1-a]isoquinolin-2-yl ester in amorphous and crystalline forms, and processes of preparation, and pharmaceutical compositions thereof. Also provided are methods of their use for treating, preventing, or ameliorating one or more symptoms of neurological disorders and diseases including hyperkinetic movement disorders or diseases.
Patent expiration dates:
- October 28, 2036✓✓✓
- October 28, 2036✓✓✓
- October 28, 2036
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Valbenazine salts and polymorphs thereof
Patent 10,844,058
Issued: November 24, 2020
Inventor(s): McGee Kevin & Zook Scott E. & Carr Andrew & Bonnaud Thierry & Li Bin-Feng
Assignee(s): Neurocrine Biosciences, Inc.Provided herein are salts of (S)-2-amino-3-methyl-butyric acid (2R,3R,11bR)-3-isobutyl-9,10-dimethoxy-1,3,4,6,7,11b-hexahydro-2H-pyrido[2,l-a]isoquinolin-2-yl ester in amorphous and crystalline forms, and processes of preparation, and pharmaceutical compositions thereof. Also provided are methods of their use for treating, preventing, or ameliorating one or more symptoms of neurological disorders and diseases including hyperkinetic movement disorders or diseases.
Patent expiration dates:
- October 28, 2036✓✓✓
- October 28, 2036✓✓✓
- October 28, 2036
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Valbenazine salts and polymorphs thereof
Patent 10,851,103
Issued: December 1, 2020
Inventor(s): McGee Kevin & Zook Scott E. & Carr Andrew & Bonnaud Thierry & Li Bin-Feng
Assignee(s): Neurocrine Biosciences, Inc.Provided herein are salts of (S)-2-amino-3-methyl-butyric acid (2R,3R,11bR)-3-isobutyl-9,10-dimethoxy-1,3,4,6,7,11b-hexahydro-2H-pyrido[2,1-a]isoquinolin-2-yl ester in amorphous and crystalline forms, and processes of preparation, and pharmaceutical compositions thereof. Also provided are methods of their use for treating, preventing, or ameliorating one or more symptoms of neurological disorders and diseases including hyperkinetic movement disorders or diseases.
Patent expiration dates:
- October 28, 2036✓✓✓
- October 28, 2036✓✓✓
- October 28, 2036
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Valbenazine salts and polymorphs thereof
Patent 10,851,104
Issued: December 1, 2020
Inventor(s): McGee Kevin & Zook Scott E. & Carr Andrew & Bonnaud Thierry & Li Bin-Feng
Assignee(s): Neurocrine Biosciences, Inc.Provided herein are salts of (S)-2-amino-3-methyl-butyric acid (2R,3R,11bR)-3-isobutyl-9,10-dimethoxy-1,3,4,6,7,11b-hexahydro-2H-pyrido[2,1-a]-isoquinolin-2-yl ester in amorphous and crystalline forms, and processes of preparation, and pharmaceutical compositions thereof. Also provided are methods of their use for treating, preventing, or ameliorating one or more symptoms of neurological disorders and diseases including hyperkinetic movement disorders or diseases.
Patent expiration dates:
- October 28, 2036✓✓
- October 28, 2036✓✓
- October 28, 2036
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Methods for the administration of certain VMAT2 inhibitors
Patent 10,857,137
Issued: December 8, 2020
Inventor(s): "OBrien Christopher F." & Bozigian Haig P.
Assignee(s): Neurocrine Biosciences, Inc.Provided are methods of administering a vesicular monoamine transport 2 (VMAT2) inhibitor chosen from valbenazine and (+)-α-3-isobutyl-9,10-dimethoxy-1,3,4,6,7,11b-hexahydro-2H-pyrido[2,1-a]isoquinolin-2-ol, or a pharmaceutically acceptable salt and/or isotopic variant thereof, to a patient in need thereof wherein the patient is a CYP2D6 poor metabolizer.
Patent expiration dates:
- October 10, 2037✓
- October 10, 2037
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Methods for the administration of certain VMAT2 inhibitors
Patent 10,857,148
Issued: December 8, 2020
Inventor(s): "OBrien Christopher F." & Bozigian Haig P.
Assignee(s): Neurocrine Biosciences, Inc.Provided are methods of administering a vesicular monoamine transport 2 (VMAT2) inhibitor chosen from valbenazine and (+)-α-3-isobutyl-9,10-dimethoxy-1,3,4,6,7,11b-hexahydro-2H-pyrido[2,1-a]isoquinolin-2-ol, or a pharmaceutically acceptable salt and/or isotopic variant thereof, to a patient in need thereof wherein the patient is also being administered digoxin.
Patent expiration dates:
- October 10, 2037✓
- October 10, 2037
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Methods for the administration of certain VMAT2 inhibitors
Patent 10,874,648
Issued: December 29, 2020
Inventor(s): "OBrien Christopher F." & Bozigian Haig P.
Assignee(s): Neurocrine Biosciences, Inc.Provided are methods of administering a vesicular monoamine transport 2 (VMAT2) inhibitor chosen from valbenazine and (+)-a-3-isobutyl-9,10-dimethoxy-1,3,4,6,7,11b-hexahydro-2H-pyrido[2,1-a]isoquinolin-2-ol, or a pharmaceutically acceptable salt and/or isotopic variant thereof to a patient in need thereof wherein the patient is being treated with a strong cytochrome P450 3A4 (CYP3A4) inducer.
Patent expiration dates:
- October 10, 2037✓
- October 10, 2037✓
- October 10, 2037✓
- October 10, 2037
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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)
Patent 10,906,902
Issued: February 2, 2021
Inventor(s): McGee Kevin & Li Bin-Feng & Branum Shawn
Assignee(s): Neurocrine Biosciences, Inc.Provided herein are processes for the 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), or a solvate, hydrate, or polymorph thereof.
Patent expiration dates:
- December 22, 2036✓✓
- December 22, 2036
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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)
Patent 10,906,903
Issued: February 2, 2021
Inventor(s): McGee Kevin & Li Bin-Feng & Branum Shawn
Assignee(s): Neurocrine Biosciences, Inc.Provided herein are processes for the 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), or a solvate, hydrate, or polymorph thereof.
Patent expiration dates:
- December 22, 2036✓✓
- December 22, 2036
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Methods for the administration of certain VMAT2 inhibitors
Patent 10,912,771
Issued: February 9, 2021
Inventor(s): "OBrien Christopher F." & Bozigian Haig P.
Assignee(s): Neurocrine Biosciences, Inc.Provided are methods of administering a vesicular monoamine transport 2 (VMAT2) inhibitor chosen from valbenazine and (+)-α-3-isobutyl-9,10-dimethoxy-1,3,4,6,7,11b-hexahydro-2H-pyrido[2,1-a]isoquinolin-2-ol, or a pharmaceutically acceptable salt and/or isotopic variant thereof to a patient in need thereof wherein the patient is being treated with a strong cytochrome P450 3A4 (CYP3A4) inducer.
Patent expiration dates:
- October 10, 2037✓
- October 10, 2037✓
- October 10, 2037✓
- October 10, 2037
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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)
Patent 10,919,892
Issued: February 16, 2021
Inventor(s): McGee; Kevin et al.
Assignee(s): Neurocrine Biosciences, Inc. (San Diego, CA)Provided herein are processes for the 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), or a solvate, hydrate, or polymorph thereof.
Patent expiration dates:
- December 22, 2036✓✓
- December 22, 2036
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Methods for the administration of certain VMAT2 inhibitors
Patent 10,940,141
Issued: March 9, 2021
Inventor(s): Loewen; Gordon Raphael et al.
Assignee(s): Neurocrine Biosciences, Inc. (San Diego, CA)Provided is a method of administering a vesicular monoamine transporter 2 (VMAT2) inhibitor to a subject in need thereof, wherein the subject has severe renal impairment.
Patent expiration dates:
- August 10, 2040✓
- August 10, 2040
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Methods for the administration of certain VMAT2 inhibitors
Patent 10,952,997
Issued: March 23, 2021
Inventor(s): "OBrien Christopher F." & Bozigian Haig P.
Assignee(s): Neurocrine Biosciences, Inc.Provided are methods of administering a vesicular monoamine transport 2 (VMAT2) inhibitor chosen from valbenazine and (+)-a-3-isobutyl-9,10-dimethoxy-1,3,4,6,7,11b-hexahydro-2H-pyrido[2,1-a]isoquinolin-2-ol, or a pharmaceutically acceptable salt and/or isotopic variant thereof, to a patient in need thereof wherein the patient is also being administered a strong cytochrome P450 3A4 (CYP3A4) inhibitor.
Patent expiration dates:
- October 10, 2037✓
- October 10, 2037
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Methods for the administration of certain VMAT2 inhibitors
Patent 10,993,941
Issued: May 4, 2021
Inventor(s): "OBrien Christopher F." & Bozigian Haig P.
Assignee(s): Neurocrine Biosciences, Inc.Provided are methods of administering a vesicular monoamine transport 2 (VMAT2) inhibitor chosen from valbenazine and (+)-α-3-isobutyl-9,10-dimethoxy-1,3,4,6,7,11b-hexahydro-2H-pyrido[2,1-a]isoquinolin-2-ol, or a pharmaceutically acceptable salt and/or isotopic variant thereof, to a patient in need thereof wherein the patient has mild, moderate, or severe hepatic impairment.
Patent expiration dates:
- October 10, 2037✓
- October 10, 2037
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Methods for the administration of certain VMAT2 inhibitors
Patent 11,026,931
Issued: June 8, 2021
Inventor(s): Liang Grace S. & "OBrien Christopher F." & Thai-Cuarto Dao Tuyet
Assignee(s): Neurocrine Biosciences, Inc.Provided are methods of administering a vesicular monoamine transport 2 (VMAT2) inhibitor chosen from valbenazine, or a pharmaceutically acceptable salt and/or isotopic variant thereof, to a patient in need thereof.
Patent expiration dates:
- August 14, 2039✓
- August 14, 2039
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High dosage valbenazine formulation and compositions, methods, and kits related thereto
Patent 11,026,939
Issued: June 8, 2021
Inventor(s): Moore & Jr. Richard Alexander & McClelland Gregory A. & O{grave over ( )}Brien Christopher F.
Assignee(s): Neurocrine Biosciences, Inc.Solid pharmaceutical compositions with high drug loading are provided. A formulation useful for the solid pharmaceutical composition includes valbenazine, or a pharmaceutically acceptable salt thereof, silicified microcrystalline cellulose, isomalt, hydroxypropyl methylcellulose, partially pregelatinized maize starch, and magnesium stearate.
Patent expiration dates:
- September 18, 2038✓✓
- September 18, 2038✓✓
- September 18, 2038
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Methods for the administration of certain VMAT2 inhibitors
Patent 11,040,029
Issued: June 22, 2021
Inventor(s): "OBrien Christopher F." & Bozigian Haig P.
Assignee(s): Neurocrine Biosciences, Inc.Provided are methods of administering a vesicular monoamine transport 2 (VMAT2) inhibitor chosen from valbenazine and (+)-α-3-isobutyl-9,10-dimethoxy-1,3,4,6,7,11b-hexahydro-2H-pyrido[2,1-a]isoquinolin-2-ol, or a pharmaceutically acceptable salt and/or isotopic variant thereof, to a patient in need thereof wherein the patient is also being administered a strong cytochrome P450 2D6 (CYP2D6) inhibitor.
Patent expiration dates:
- October 10, 2037✓
- October 10, 2037
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High dosage valbenazine formulation and compositions, methods, and kits related thereto
Patent 11,311,532
Issued: April 26, 2022
Inventor(s): Moore, Jr.; Richard Alexander et al.
Assignee(s): Neurocrine Biosciences, Inc. (San Diego, CA)Solid pharmaceutical compositions with high drug loading are provided. A formulation useful for the solid pharmaceutical composition includes valbenazine, or a pharmaceutically acceptable salt thereof, silicified microcrystalline cellulose, isomalt, hydroxypropyl methylcellulose, partially pregelatinized maize starch, and magnesium stearate.
Patent expiration dates:
- September 18, 2038✓✓
- September 18, 2038✓✓
- September 18, 2038
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Methods for the administration of certain VMAT2 inhibitors
Patent 11,439,629
Issued: September 13, 2022
Inventor(s): "OBrien Christopher F." & Bozigian Haig P.
Assignee(s): Neurocrine Biosciences, Inc.Provided are methods of administering a vesicular monoamine transport 2 (VMAT2) inhibitor chosen from valbenazine and (+)-α-3-isobutyl-9,10-dimethoxy-1, 3,4, 6,7,11 b-hexahydro-2H-pyrido[2,1-a]isoquinolin-2-ol, or a pharmaceutically acceptable salt and/or isotopic variant thereof, to a patient in need thereof wherein the patient is a CYP2D6 poor metabolizer.
Patent expiration dates:
- October 10, 2037✓
- October 10, 2037
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Methods for the administration of certain VMAT2 inhibitors
Patent 11,654,142
Issued: May 23, 2023
Inventor(s): O'Brien; Christopher F. et al.
Assignee(s): Neurocrine Biosciences, Inc. (San Diego, CA)Provided are methods of administering a vesicular monoamine transport 2 (VMAT2) inhibitor chosen from valbenazine and (+)-α-3-isobutyl-9,10-dimethoxy-1,3,4,6,7,1 1b-hexahydro-2H-pyrido[2,1-a]isoquinolin-2-ol, or a pharmaceutically acceptable salt and/or isotopic variant thereof, to a patient in need thereof wherein the patient is also being administered digoxin.
Patent expiration dates:
- November 14, 2038✓
- November 14, 2038
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Substituted 3-isobutyl-9,10-dimethoxy-1,3,4,6,7,11b-hexahydro-2H-pyrido[2,1-A]isoquin- olin-2-ol compounds and methods relating thereto
Patent 8,039,627
Issued: October 18, 2011
Inventor(s): Gano; Kyle W.
Assignee(s): Neurocrine Biosciences, Inc. (San Diego, CA)Substituted 3-isobutyl-9,10-dimethoxy-1,3,4,6,7,11b-hexahydro-2H-pyrido[2,1-a]isoquin- olin-2-ol compounds are disclosed that are inhibitors of the vesicular monoamine transporter 2 (VMAT2). The compounds of this invention have the structure: ##STR00001## wherein R.sub.1 is as defined herein, including stereoisomers and pharmaceutically acceptable salts and solvates thereof. Also disclosed are compositions containing a compound of this invention in combination with a pharmaceutically acceptable carrier, as well as methods relating to the use in a subject in need thereof.
Patent expiration dates:
- April 11, 2031✓✓
- April 11, 2031
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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
Patent 8,357,697
Issued: January 22, 2013
Inventor(s): Gano Kyle W.
Assignee(s): Neurocrine Biosciences, Inc.Substituted 3-isobutyl-9,10-dimethoxy-1,3,4,6,7,11b-hexahydro-2H-pyrido[2,1-a]isoquinolin-2-ol compounds are disclosed that are inhibitors of the vesicular monoamine transporter 2 (VMAT2). The compounds of this invention have the structure:
Patent expiration dates:
- November 8, 2027✓
- November 8, 2027✓
- November 8, 2027
Related exclusivities
Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.
Exclusivity expiration dates:
- August 18, 2026 - TREATMENT OF ADULTS WITH CHOREA ASSOCIATED WITH HUNTINGTON’S DISEASE
- August 18, 2030 - FOR TREATMENT OF ADULTS WITH CHOREA ASSOCIATED WITH HUNTINGTON'S DISEASE
More about Ingrezza (valbenazine)
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- FDA approval history
- Drug class: VMAT2 inhibitors
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- En español
Patient resources
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Glossary
Term | Definition |
---|---|
Drug Patent | A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation. |
Drug Exclusivity | Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant. |
RLD | A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart. |
AB | Products meeting necessary bioequivalence requirements. Multisource drug products listed under the same heading (e.g. identical active ingredients, dosage form, and routes of administration) and having the same strength (see Therapeutic Equivalence-Related Terms, Pharmaceutical Equivalents) generally will be coded AB if a study is submitted demonstrating bioequivalence. In certain instances, a number is added to the end of the AB code to make a three character code (e.g. AB1, AB2, AB7). Three-character codes are assigned only in situations when more than one reference listed drug of the same strength has been designated under the same heading. Two or more reference listed drugs are generally selected only when there are at least two potential reference drug products which are not bioequivalent to each other. If a study is submitted that demonstrates bioequivalence to a specific listed drug product, the generic product will be given the same three-character code as the reference listed drug it was compared against. |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.