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Last Updated: October 12, 2024

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-seven 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 19th, 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: 2,506
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

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

SponsorPhase
Medical College of WisconsinPhase 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

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

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 021745-003 Dec 30, 2008 ⤷  Sign Up ⤷  Sign Up
Purdue Pharma RYZOLT tramadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 021745-002 Dec 30, 2008 ⤷  Sign Up ⤷  Sign Up
Purdue Pharma RYZOLT tramadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 021745-002 Dec 30, 2008 ⤷  Sign Up ⤷  Sign Up
Purdue Pharma RYZOLT tramadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 021745-002 Dec 30, 2008 ⤷  Sign Up ⤷  Sign Up
Purdue Pharma RYZOLT tramadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 021745-003 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.

Country Patent Number Title Estimated Expiration
South Africa 9201366 ⤷  Sign Up
South Africa 9409296 ⤷  Sign Up
Indonesia 25988 ⤷  Sign Up
Norway 924597 ⤷  Sign Up
India 173298 Method for obtaining a stabilized controlled release formulation ⤷  Sign Up
Australia 682223 ⤷  Sign Up
Spain 2088312 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for RYZOLT

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

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.