QUILLIVANT XR Drug Patent Profile
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When do Quillivant Xr patents expire, and what generic alternatives are available?
Quillivant Xr is a drug marketed by Nextwave and is included in one NDA. There are seven patents protecting this drug and one Paragraph IV challenge.
This drug has thirty patent family members in fourteen countries.
The generic ingredient in QUILLIVANT XR is methylphenidate hydrochloride. There are thirty-two drug master file entries for this compound. Forty-seven suppliers are listed for this compound. Additional details are available on the methylphenidate hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Quillivant Xr
A generic version of QUILLIVANT XR was approved as methylphenidate hydrochloride by SPECGX LLC on November 27th, 1998.
Summary for QUILLIVANT XR
International Patents: | 30 |
US Patents: | 7 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 62 |
Clinical Trials: | 4 |
Patent Applications: | 3,514 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for QUILLIVANT XR |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for QUILLIVANT XR |
DailyMed Link: | QUILLIVANT XR at DailyMed |
Recent Clinical Trials for QUILLIVANT XR
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University of California, Davis | Phase 1 |
Matthew O'Brien | Phase 4 |
Matthew J O'Brien, PhD, BCBA-D | Phase 4 |
Pharmacology for QUILLIVANT XR
Drug Class | Central Nervous System Stimulant |
Physiological Effect | Central Nervous System Stimulation |
Anatomical Therapeutic Chemical (ATC) Classes for QUILLIVANT XR
Paragraph IV (Patent) Challenges for QUILLIVANT XR
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
QUILLIVANT XR | Extended-release Oral Suspension | methylphenidate hydrochloride | 5 mg/mL | 202100 | 2013-08-02 |
US Patents and Regulatory Information for QUILLIVANT XR
QUILLIVANT XR is protected by seven US patents.
Patents protecting QUILLIVANT XR
Modified release formulations containing drug-ion exchange resin complexes
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Orally effective methylphenidate extended release powder and aqueous suspension product
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Orally effective methylphenidate extended release powder and aqueous suspension product
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATING A PATIENT HAVING A CONDITION SUSCEPTIBLE TO TREATMENT WITH METHYLPHENIDATE, SUCH AS ADHD, BY ADMINISTERING THE FORMULATION RECITED IN CLAIMS 1 OR 2
Orally effective methylphenidate extended release powder and aqueous suspension product
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATING A PATIENT HAVING A CONDITION SUSCEPTIBLE TO TREATMENT WITH METHYLPHENIDATE, SUCH AS ADHD, BY ADMINISTERING THE FORMULATION RECITED IN CLAIMS 1 OR 2
Orally effective methylphenidate extended release powder and aqueous suspension product
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF A PATIENT BY ADMINISTERING THE FORMULATION RECITED IN CLAIM 1 OR CLAIM 23
Orally effective methylphenidate extended release powder and aqueous suspension product
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER BY ADMINISTERING THE COMPOSITION OF CLAIM 1
Orally effective methylphenidate extended release powder and aqueous suspension product
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Nextwave | QUILLIVANT XR | methylphenidate hydrochloride | FOR SUSPENSION, EXTENDED RELEASE;ORAL | 202100-001 | Sep 27, 2012 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
Nextwave | QUILLIVANT XR | methylphenidate hydrochloride | FOR SUSPENSION, EXTENDED RELEASE;ORAL | 202100-001 | Sep 27, 2012 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
Nextwave | QUILLIVANT XR | methylphenidate hydrochloride | FOR SUSPENSION, EXTENDED RELEASE;ORAL | 202100-001 | Sep 27, 2012 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a 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 QUILLIVANT XR
See the table below for patents covering QUILLIVANT XR around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
China | 102488652 | Modified release formulations containing drug-ion exchange resin complexes | ⤷ Try a Trial |
Denmark | 2675438 | ⤷ Try a Trial | |
Japan | 5479086 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |