METADATE CD Drug Patent Profile

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When do Metadate Cd patents expire, and when can generic versions of Metadate Cd launch?

Metadate Cd is a drug marketed by Aytu Biopharma and is included in one NDA.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Metadate Cd

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

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Summary for METADATE CD

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	23
Clinical Trials:	6
Patent Applications:	3,544
Drug Prices:	Drug price information for METADATE CD
What excipients (inactive ingredients) are in METADATE CD?	METADATE CD excipients list
DailyMed Link:	METADATE CD at DailyMed

Drug patent expirations by year for METADATE CD

Recent Clinical Trials for METADATE CD

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

Sponsor	Phase
Matthew J O'Brien, PhD, BCBA-D	Phase 4
Matthew O'Brien	Phase 4
Craig Rush	Early Phase 1

See all METADATE CD clinical trials

Pharmacology for METADATE CD

Drug Class	Central Nervous System Stimulant
Physiological Effect	Central Nervous System Stimulation

Paragraph IV (Patent) Challenges for METADATE CD

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
METADATE CD	Extended-release Capsules	methylphenidate hydrochloride	40 mg	021259	1	2007-03-15
METADATE CD	Extended-release Capsules	methylphenidate hydrochloride	10 mg, 20 mg and 30 mg	021259	1	2005-05-13

US Patents and Regulatory Information for METADATE CD

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Glossary

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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
Aytu Biopharma	METADATE CD	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021259-003	May 27, 2003	AB2	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Aytu Biopharma	METADATE CD	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021259-004	Feb 19, 2006	AB2	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Aytu Biopharma	METADATE CD	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021259-001	Apr 3, 2001	AB2	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Aytu Biopharma	METADATE CD	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021259-002	Jun 19, 2003	AB2	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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 METADATE CD

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Aytu Biopharma	METADATE CD	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021259-003	May 27, 2003	⤷ Sign Up	⤷ Sign Up
Aytu Biopharma	METADATE CD	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021259-004	Feb 19, 2006	⤷ Sign Up	⤷ Sign Up
Aytu Biopharma	METADATE CD	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021259-002	Jun 19, 2003	⤷ Sign Up	⤷ Sign Up
Aytu Biopharma	METADATE CD	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021259-001	Apr 3, 2001	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for METADATE CD

See the table below for patents covering METADATE CD around the world.

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Country	Patent Number	Title	Estimated Expiration
European Patent Office	2103307	Formulations de libération modifiée de méthylphénidate (Methylphenidate modified release formulations)	⤷ Sign Up
Portugal	2103307		⤷ Sign Up
Hungary	0303695		⤷ Sign Up
Canada	2426883	FORMULATIONS A LIBERATION MODIFIEE PAR METHYLPHENIDATE (METHYLPHENIDATE MODIFIED RELEASE FORMULATIONS)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration