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Generic QuilliChew ER Availability

See also: Generic Quillivant XR

QuilliChew ER is a brand name of methylphenidate, approved by the FDA in the following formulation(s):

QUILLICHEW ER (methylphenidate hydrochloride - tablet, extended release, chewable;oral)

  • Manufacturer: PFIZER INC
    Approval date: December 4, 2015
    Strength(s): 20MG, 30MG, 40MG [RLD]

Has a generic version of QuilliChew ER been approved?

No. There is currently no therapeutically equivalent version of QuilliChew ER available in the United States.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of QuilliChew ER. 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: About generic drugs.

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.

  • Modified release formulations containing drug-ion exchange resin complexes
    Patent 8,202,537
    Issued: June 19, 2012
    Inventor(s): Mehta; Ketan & Tu; Yu-Hsing
    Assignee(s): Tris Pharma Inc
    A solid dose composition containing a mixture of a cured, modified release-barrier coated methylphenidate-ion exchange resin complex-matrix and an uncoated methylphenidate-ion exchange resin complex is described. The barrier coated methylphenidate-ion exchange resin complex-matrix comprises methylphenidate complexed with a pharmaceutically acceptable ion-exchange resin to form the complex which is admixed with a polymer to form a methylphenidate-ion exchange resin complex-matrix, which is subsequently coated with a modified release coating. The modified coating contains polyvinyl acetate polymer and a plasticizer and is cured.
    Patent expiration dates:
    • March 15, 2027
      ✓ 
      Drug product
  • 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 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
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      Drug product
  • Methylphenidate extended release chewable tablet
    Patent 8,999,386
    Issued: April 7, 2015
    Assignee(s): TRIS Pharma, Inc.
    An oral methylphenidate extended release tablet is described, which can be scored and still retain its extended release profile. The tablet contains a combination of an uncoated methylphenidate-ion exchange resin complex, a barrier coated methylphenidate-ion exchange resin complex-matrix, and an uncomplexed methylphenidate active component. Following administration of a single dose of the extended release methylphenidate chewable tablet, a therapeutically effective amount of methylphenidate is reached in less than about 20 minutes and the composition provides a twelve-hour extended release profile.
    Patent expiration dates:
    • August 14, 2033
      ✓ 
      Drug product
  • Methylphenidate extended release chewable tablet
    Patent 9,295,642
    Issued: March 29, 2016
    Assignee(s): Tris Pharma, Inc.
    An oral methylphenidate extended release tablet is described, which can be scored and still retain its extended release profile. The tablet contains a combination of an uncoated methylphenidate-ion exchange resin complex, a barrier coated methylphenidate-ion exchange resin complex-matrix, and an uncomplexed methylphenidate active component. Following administration of a single dose of the extended release methylphenidate chewable tablet, a therapeutically effective amount of methylphenidate is reached in less than about 20 minutes and the composition provides a twelve-hour extended release profile.
    Patent expiration dates:
    • August 14, 2033
      ✓ 
      Patent use: A METHOD OF PROVIDING A SUBJECT WITH THERAPEUTICALLY EFFECTIVE AMOUNT OF RACEMIC METHYLPHENIDATE BY ORALLY ADMINISTERING TO SAID SUBJECT A SINGLE METHYLPHENIDATE EXTENDED RELEASE CHEWBLE TABLET ACCORDING TO CLAIM 1
      ✓ 
      Drug product

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:
    • December 4, 2018 - NEW PRODUCT

Glossary

TermDefinition
Drug PatentA 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 ExclusivityExclusivity 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.
RLDA 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.
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