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Last Updated: November 22, 2019

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APTENSIO XR Drug Profile

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Which patents cover Aptensio Xr, and when can generic versions of Aptensio Xr launch?

Aptensio Xr is a drug marketed by Rhodes Pharms and is included in one NDA. There are eight patents protecting this drug and four Paragraph IV challenges.

This drug has thirty-seven patent family members in fourteen countries.

The generic ingredient in APTENSIO XR is methylphenidate hydrochloride. There are thirty-two drug master file entries for this compound. Forty-two suppliers are listed for this compound. Additional details are available on the methylphenidate hydrochloride profile page.

Drug patent expirations by year for APTENSIO XR
Drug Prices for APTENSIO XR

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Recent Clinical Trials for APTENSIO XR

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SponsorPhase
Matthew O'BrienPhase 4
Rhodes Pharmaceuticals, L.P.Phase 4

See all APTENSIO XR clinical trials

Recent Litigation for APTENSIO XR

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District Court Litigation
Case NameDate
RHODES PHARMACEUTICALS L.P. v. ACTAVIS, INC.2016-03-25
Tris Pharma Inc. v. Actavis Laboratories FL Inc.2014-10-15

See all APTENSIO XR litigation

Pharmacology for APTENSIO XR
Paragraph IV (Patent) Challenges for APTENSIO XR
Tradename Dosage Ingredient NDA Submissiondate
APTENSIO XR CAPSULE, EXTENDED RELEASE;ORAL methylphenidate hydrochloride 205831 2015-12-24
APTENSIO XR CAPSULE, EXTENDED RELEASE;ORAL methylphenidate hydrochloride 205831 2015-12-23

US Patents and Regulatory Information for APTENSIO XR

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Rhodes Pharms APTENSIO XR methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 205831-006 Apr 17, 2015 AB3 RX Yes No   Start Trial   Start Trial Y   Start Trial
Rhodes Pharms APTENSIO XR methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 205831-004 Apr 17, 2015 AB3 RX Yes No   Start Trial   Start Trial Y   Start Trial
Rhodes Pharms APTENSIO XR methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 205831-007 Apr 17, 2015 AB3 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Rhodes Pharms APTENSIO XR methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 205831-006 Apr 17, 2015 AB3 RX Yes No   Start Trial   Start Trial Y   Start Trial
Rhodes Pharms APTENSIO XR methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 205831-007 Apr 17, 2015 AB3 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Rhodes Pharms APTENSIO XR methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 205831-007 Apr 17, 2015 AB3 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Rhodes Pharms APTENSIO XR methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 205831-004 Apr 17, 2015 AB3 RX Yes No   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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