Generic Quillivant XR Availability
Last updated on Apr 10, 2025.
See also: Generic QuilliChew ER
Quillivant XR is a brand name of methylphenidate, approved by the FDA in the following formulation(s):
QUILLIVANT XR (methylphenidate hydrochloride - for suspension, extended release;oral)
Is there a generic version of Quillivant XR available?
A generic version of Quillivant XR 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 Quillivant XR and have been approved by the FDA:
methylphenidate hydrochloride for suspension, extended release;oral
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Manufacturer: ACTAVIS LABS FL INC
Approval date: May 17, 2018
Strength(s): 5MG/ML [AB]
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Quillivant XR. 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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Modified release formulations containing drug-ion exchange resin complexes
Patent 8,062,667
Issued: November 22, 2011
Inventor(s): Mehta; Ketan et al.
Assignee(s): Tris Pharma, Inc. (Monmouth Junction, NJ)A coated drug-ion exchange resin complex comprising a core composed of a drug complexed with a pharmaceutically acceptable ion-exchange resin is provided. The drug-ion exchange resin complex is in admixture with a release retardant. The coating is a polyvinyl acetate polymer and a plasticizer. Methods of making and products containing this coated complex are described.
Patent expiration dates:
- March 29, 2029✓
- March 29, 2029
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Orally effective methylphenidate extended release powder and aqueous suspension product
Patent 8,287,903
Issued: October 16, 2012
Inventor(s): Mehta Ketan & Tu Yu-Hsing & Perumal Ashok
Assignee(s): Tris Pharma IncAn oral methylphenidate powder which is reconstitutable into a final oral aqueous sustained release formulation containing at least about 50%, or at least about 80% by weight water based on the total weight of the suspension, is provided. The powder is a blend containing a combination of an uncoated methylphenidate-ion exchange resin complex, a barrier coated methylphenidate-ion exchange resin complex-matrix, and a water soluble buffering agent such that upon formed into an aqueous liquid formulation, the formulation has a pH in the range of about 3.5 to about 5, or about 4 to about 4.5. Following administration of a single dose of the oral aqueous methylphenidate suspension, a therapeutically effective amount of methylphenidate is reached in less than one hour and the composition provides a twelve-hour extended release profile.
Patent expiration dates:
- February 15, 2031✓
- February 15, 2031
-
Orally effective methylphenidate extended release powder and aqueous suspension product
Patent 8,465,765
Issued: June 18, 2013
Inventor(s): Mehta Ketan & Tu Yu-Hsing & Perumal Ashok
Assignee(s): Tris Pharma, Inc.An oral methylphenidate powder which is reconstitutable into a final oral aqueous sustained release formulation containing at least about 50%, or at least about 80% by weight water based on the total weight of the suspension, is provided. The powder is a blend containing a combination of an uncoated methylphenidate-ion exchange resin complex, a barrier coated methylphenidate-ion exchange resin complex-matrix, and a water soluble buffering agent such that upon formed into an aqueous liquid formulation, the formulation has a pH in the range of about 3.5 to about 5, or about 4 to about 4.5. Following administration of a single dose of the oral aqueous methylphenidate suspension, a therapeutically effective amount of methylphenidate is reached in less than one hour and the composition provides a twelve-hour extended release profile.
Patent expiration dates:
- February 15, 2031✓✓
- February 15, 2031
-
Orally effective methylphenidate extended release powder and aqueous suspension product
Patent 8,563,033
Issued: October 22, 2013
Inventor(s): Mehta Ketan & Tu Yu-Hsing & Perumal Ashok
Assignee(s): Tris Pharma Inc.An oral methylphenidate powder which is reconstitutable into a final oral aqueous sustained release formulation containing at least about 50%, or at least about 80% by weight water based on the total weight of the suspension, is provided. The powder is a blend containing a combination of an uncoated methylphenidate—ion exchange resin complex, a barrier coated methylphenidate—ion exchange resin complex—matrix, and a water soluble buffering agent such that upon formed into an aqueous liquid formulation, the formulation has a pH in the range of about 3.5 to about 5, or about 4 to about 4.5. Following administration of a single dose of the oral aqueous methylphenidate suspension, a therapeutically effective amount of methylphenidate is reached in less than one hour and the composition provides a twelve-hour extended release profile.
Patent expiration dates:
- February 15, 2031✓✓
- February 15, 2031
-
Orally effective methylphenidate extended release powder and aqueous suspension product
Patent 8,778,390
Issued: July 15, 2014
Inventor(s): Mehta Ketan & Tu Yu-Hsing & Perumal Ashok
Assignee(s): TRIS Pharma, Inc.An oral methylphenidate powder which is reconstitutable into a final oral aqueous sustained release formulation containing at least about 50%, or at least about 80% by weight water based on the total weight of the suspension, is provided. The powder is a blend containing a combination of an uncoated methylphenidate-ion exchange resin complex, a barrier coated methylphenidate-ion exchange resin complex-matrix, and a water soluble buffering agent such that upon formed into an aqueous liquid formulation, the formulation has a pH in the range of about 3.5 to about 5, or about 4 to about 4.5. Following administration of a single dose of the oral aqueous methylphenidate suspension, a therapeutically effective amount of methylphenidate is reached in less than one hour and the composition provides a twelve-hour extended release profile.
Patent expiration dates:
- February 15, 2031✓✓
- February 15, 2031
-
Orally effective methylphenidate extended release powder and aqueous suspension product
Patent 8,956,649
Issued: February 17, 2015
Inventor(s): Mehta Ketan & Tu Yu-Hsing & Perumal Ashok
Assignee(s): Tris Pharma, IncAn oral methylphenidate powder which is reconstitutable into a final oral aqueous sustained release formulation containing at least about 50%, or at least about 80% by weight water based on the total weight of the suspension, is provided. The powder is a blend containing a combination of an uncoated methylphenidate-ion exchange resin complex, a barrier coated methylphenidate-ion exchange resin complex-matrix, and a water soluble buffering agent such that upon formed into an aqueous liquid formulation, the formulation has a pH in the range of about 3.5 to about 5, or about 4 to about 4.5. Following administration of a single dose of the oral aqueous methylphenidate suspension, a therapeutically effective amount of methylphenidate is reached in less than one hour and the composition provides a twelve-hour extended release profile.
Patent expiration dates:
- February 15, 2031✓✓
- February 15, 2031
-
Orally effective methylphenidate extended release powder and aqueous suspension product
Patent 9,040,083
Issued: May 26, 2015
Inventor(s): Mehta Ketan & Tu Yu-Hsing & Perumal Ashok
Assignee(s): TRIS PHARMA, INCAn oral methylphenidate powder which is reconstitutable into a final oral aqueous sustained release formulation containing at least about 50%, or at least about 80% by weight water based on the total weight of the suspension, is provided. The powder is a blend containing a combination of an uncoated methylphenidate-ion exchange resin complex, a barrier coated methylphenidate-ion exchange resin complex-matrix, and a water soluble buffering agent such that upon formed into an aqueous liquid formulation, the formulation has a pH in the range of about 3.5 to about 5, or about 4 to about 4.5. Following administration of a single dose of the oral aqueous methylphenidate suspension, a therapeutically effective amount of methylphenidate is reached in less than one hour and the composition provides a twelve-hour extended release profile.
Patent expiration dates:
- February 15, 2031✓
- February 15, 2031
More about Quillivant XR (methylphenidate)
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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.