Last Updated: June 17, 2026

RELEXXII Drug Patent Profile

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When do Relexxii patents expire, and what generic alternatives are available?

Relexxii is a drug marketed by Osmotica Pharm Us and is included in one NDA. There are five patents protecting this drug.

This drug has four patent family members in four countries.

The generic ingredient in RELEXXII 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.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Relexxii

A generic version of RELEXXII was approved as methylphenidate hydrochloride by SPECGX LLC on November 27^th, 1998.

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Summary for RELEXXII

International Patents:	4
US Patents:	5
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for RELEXXII

RELEXXII is protected by five US patents.

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Osmotica Pharm Us	RELEXXII	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE;ORAL	216117-007	Jun 23, 2022		RX	Yes	Yes	10,265,308	⤷ Start Trial	Y			⤷ Start Trial
Osmotica Pharm Us	RELEXXII	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE;ORAL	216117-006	Jun 23, 2022		RX	Yes	No	9,855,258	⤷ Start Trial	Y			⤷ Start Trial
Osmotica Pharm Us	RELEXXII	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE;ORAL	216117-007	Jun 23, 2022		RX	Yes	Yes	9,855,258	⤷ Start Trial	Y			⤷ Start Trial
Osmotica Pharm Us	RELEXXII	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE;ORAL	216117-006	Jun 23, 2022		RX	Yes	No	9,827,234	⤷ Start Trial				⤷ Start Trial
Osmotica Pharm Us	RELEXXII	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE;ORAL	216117-001	Jun 23, 2022		RX	Yes	No	10,695,336	⤷ Start Trial				⤷ Start Trial
Osmotica Pharm Us	RELEXXII	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE;ORAL	216117-004	Jun 23, 2022		RX	Yes	No	9,855,258	⤷ 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

International Patents for RELEXXII

See the table below for patents covering RELEXXII around the world.

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Country	Patent Number	Title	Estimated Expiration
Argentina	109157		⤷ Start Trial
Uruguay	37344		⤷ Start Trial
Uruguay	37344	FORMA DE DOSIFICACIÓN DE LIBERACIÓN CONTROLADA RESISTENTE A LA LIBERACIÓN ABRUPTA DE LA DOSIS	⤷ Start Trial
Chile	2017001919	Forma de dosificación de liberación controlada resistente a la liberación abrupta de la dosis.	⤷ Start Trial
Uruguay	37344		⤷ Start Trial
Argentina	109157	FORMA DE DOSIFICACIÓN DE LIBERACIÓN CONTROLADA RESISTENTE A LA LIBERACIÓN ABRUPTA DE LA DOSIS	⤷ Start Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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