.

Pharmaceutical Business Intelligence

  • Anticipate P&T budget requirements
  • Evaluate market entry opportunities
  • Find generic sources and suppliers
  • Predict branded drug patent expiration

► Plans and Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021745

« Back to Dashboard
NDA 021745 describes RYZOLT, which is a drug marketed by Purdue Pharma and is included in one NDA. It is available from two suppliers. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the RYZOLT profile page.

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

Summary for NDA: 021745

Tradename:
RYZOLT
Applicant:
Purdue Pharma
Ingredient:
tramadol hydrochloride
Patents:2
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details

Pharmacology for NDA: 021745

Mechanism of ActionFull Opioid Agonists

Suppliers and Packaging for NDA: 021745

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RYZOLT
tramadol hydrochloride
TABLET, EXTENDED RELEASE;ORAL 021745 NDA Stat Rx USA 16590-244 16590-244-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (16590-244-30)
RYZOLT
tramadol hydrochloride
TABLET, EXTENDED RELEASE;ORAL 021745 NDA Stat Rx USA 16590-244 16590-244-60 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (16590-244-60)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength100MG
Approval Date:Dec 30, 2008TE:RLD:No
Patent:6,607,748Patent Expiration:Jun 29, 2020Product Flag?YSubstance Flag?Delist Request?
Patent:7,988,998Patent Expiration:Oct 27, 2023Product Flag?YSubstance Flag?Delist Request?

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength200MG
Approval Date:Dec 30, 2008TE:RLD:No
Patent:6,607,748Patent Expiration:Jun 29, 2020Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book Patents for NDA: 021745

These historical archives are available as an add-on to one-year subscriptions.
See the Subscription Options for more information.

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Purdue Pharma
RYZOLT
tramadol hydrochloride
TABLET, EXTENDED RELEASE;ORAL021745-003Dec 30, 20086,254,887► subscribe
Purdue Pharma
RYZOLT
tramadol hydrochloride
TABLET, EXTENDED RELEASE;ORAL021745-001Dec 30, 20085,591,452► subscribe
Purdue Pharma
RYZOLT
tramadol hydrochloride
TABLET, EXTENDED RELEASE;ORAL021745-003Dec 30, 20085,591,452► subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.



Complete Access Available with Subscription
« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

How are People Using DrugPatentWatch?

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 verifification 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.

`abc