RYZOLT Drug Patent Profile

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

Ryzolt is a drug marketed by Purdue Pharma and is included in one NDA.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Ryzolt

A generic version of RYZOLT was approved as tramadol hydrochloride by SUN PHARM INDS INC on June 19^th, 2002.

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Summary for RYZOLT

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	142
Clinical Trials:	1
Patent Applications:	3,459
What excipients (inactive ingredients) are in RYZOLT?	RYZOLT excipients list
DailyMed Link:	RYZOLT at DailyMed

Drug patent expirations by year for RYZOLT

Recent Clinical Trials for RYZOLT

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Sponsor	Phase
Medical College of Wisconsin	Phase 2

See all RYZOLT clinical trials

Paragraph IV (Patent) Challenges for RYZOLT

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
RYZOLT	Extended-release Tablets	tramadol hydrochloride	100 mg, 200 mg and 300 mg	021745	1	2009-06-18

US Patents and Regulatory Information for RYZOLT

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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
Purdue Pharma	RYZOLT	tramadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021745-001	Dec 30, 2008		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Purdue Pharma	RYZOLT	tramadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021745-002	Dec 30, 2008		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Purdue Pharma	RYZOLT	tramadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021745-003	Dec 30, 2008		DISCN	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 RYZOLT

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Purdue Pharma	RYZOLT	tramadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021745-003	Dec 30, 2008	⤷ Sign Up	⤷ Sign Up
Purdue Pharma	RYZOLT	tramadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021745-001	Dec 30, 2008	⤷ Sign Up	⤷ Sign Up
Purdue Pharma	RYZOLT	tramadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021745-001	Dec 30, 2008	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for RYZOLT

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

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Country	Patent Number	Title	Estimated Expiration
Brazil	0315657	Formulação de dosagem sólida, comprimido para liberação controlada, método de fabricar uma medicação de liberação controlada, composição farmacêutica e uso de uma composição	⤷ Sign Up
New Zealand	245298	PREPARATION OF A CONTROLLED RELEASE FORMULATION BY COATING A SUBSTRATE WITH AN AQUEOUS DISPERSION OF PLASTICISED ACRYLIC POLYMER AND THEN CURING THE COATING	⤷ Sign Up
Denmark	0624366		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for RYZOLT

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0566709	SPC/GB04/012	United Kingdom	⤷ Sign Up	PRODUCT NAME: TRAMADOL HYDROCHLORIDE, PARACETAMOL; REGISTERED: FR NL 25970 20020405; UK PL 00242/0384 20030925
0566709	C300152	Netherlands	⤷ Sign Up	PRODUCT NAME: TRAMADOLI HYDROCHLORIDUM EN PARACETAMOLUM; NAT. REGISTRATION NO/DATE: RVG 28113 20030115; FIRST REGISTRATION: 359 228-3 2002050405
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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Summary for RYZOLT

Recent Clinical Trials for RYZOLT

Paragraph IV (Patent) Challenges for RYZOLT

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