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Last Updated: June 29, 2022

APTENSIO XR Drug Patent 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.

The generic ingredient in APTENSIO XR is methylphenidate hydrochloride. There are thirty-two drug master file entries for this compound. Forty-four 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

See drug prices for APTENSIO XR

Recent Clinical Trials for APTENSIO XR

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Matthew O'BrienPhase 4
Matthew J O'Brien, PhD, BCBA-DPhase 4
Rhodes Pharmaceuticals, L.P.Phase 4

See all APTENSIO XR clinical trials

Pharmacology for APTENSIO XR
Paragraph IV (Patent) Challenges for APTENSIO XR
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
APTENSIO XR Extended-release Capsules methylphenidate hydrochloride 30 mg 205831 1 2016-03-28
APTENSIO XR Extended-release Capsules methylphenidate hydrochloride 15 mg, 20 mg, 40 mg and 50 mg 205831 1 2015-12-28
APTENSIO XR Extended-release Capsules methylphenidate hydrochloride 10 mg 205831 1 2015-12-24
APTENSIO XR Extended-release Capsules methylphenidate hydrochloride 60 mg 205831 1 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 205831-001 Apr 17, 2015 AB3 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Rhodes Pharms APTENSIO XR methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 205831-007 Apr 17, 2015 AB3 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Rhodes Pharms APTENSIO XR methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 205831-004 Apr 17, 2015 AB3 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Rhodes Pharms APTENSIO XR methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 205831-002 Apr 17, 2015 AB3 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Rhodes Pharms APTENSIO XR methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 205831-003 Apr 17, 2015 AB3 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for APTENSIO XR

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Rhodes Pharms APTENSIO XR methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 205831-004 Apr 17, 2015 See Plans and Pricing See Plans and Pricing
Rhodes Pharms APTENSIO XR methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 205831-006 Apr 17, 2015 See Plans and Pricing See Plans and Pricing
Rhodes Pharms APTENSIO XR methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 205831-001 Apr 17, 2015 See Plans and Pricing See Plans and Pricing
Rhodes Pharms APTENSIO XR methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 205831-003 Apr 17, 2015 See Plans and Pricing See Plans and Pricing
Rhodes Pharms APTENSIO XR methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 205831-007 Apr 17, 2015 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for APTENSIO XR

See the table below for patents covering APTENSIO XR around the world.

Country Patent Number Title Estimated Expiration
Portugal 1140088 See Plans and Pricing
Slovenia 1967191 See Plans and Pricing
Slovenia 1140088 See Plans and Pricing
European Patent Office 1967191 Formulations orales de methylphenidate a liberation regulee/modifiee (Controlled/modified release oral methylphenidate formulations) See Plans and Pricing
World Intellectual Property Organization (WIPO) 0035450 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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