You are 3 steps away
from making better decisions

Serving leading biopharmaceutical companies globally:

McKesson
Colorcon
Johnson and Johnson
Medtronic
Mallinckrodt
Moodys

Last Updated: May 28, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204592


Email this page to a colleague

» See Plans and Pricing

« Back to Dashboard

NDA 204592 describes ZORVOLEX, which is a drug marketed by Zyla and is included in one NDA. It is available from two suppliers. There are seven patents protecting this drug and one Paragraph IV challenge. Additional details are available on the ZORVOLEX profile page.

The generic ingredient in ZORVOLEX is diclofenac. There are forty-seven drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the diclofenac profile page.
Summary for 204592
Tradename:ZORVOLEX
Applicant:Zyla
Ingredient:diclofenac
Patents:7
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 204592
Generic Entry Date for 204592*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for NDA: 204592
Medical Subject Heading (MeSH) Categories for 204592
Suppliers and Packaging for NDA: 204592
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZORVOLEX diclofenac CAPSULE;ORAL 204592 NDA Iroko Pharmaceuticals LLC 42211-203 42211-203-23 30 CAPSULE in 1 BOTTLE (42211-203-23)
ZORVOLEX diclofenac CAPSULE;ORAL 204592 NDA Iroko Pharmaceuticals LLC 42211-203 42211-203-29 90 CAPSULE in 1 BOTTLE (42211-203-29)
Paragraph IV (Patent) Challenges for 204592
Tradename Dosage Ingredient NDA Submissiondate
ZORVOLEX CAPSULE;ORAL diclofenac 204592 2014-06-06

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength18MG
Approval Date:Oct 18, 2013TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Apr 23, 2030Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Apr 23, 2030Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF PAIN
Patent:  Start TrialPatent Expiration:Apr 23, 2030Product Flag?YSubstance Flag?Delist Request?

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Colorcon
Boehringer Ingelheim
Moodys
Express Scripts
Mallinckrodt
Johnson and Johnson

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.