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Last Updated: May 27, 2022

ZORVOLEX Drug Patent Profile


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Which patents cover Zorvolex, and when can generic versions of Zorvolex launch?

Zorvolex is a drug marketed by Zyla and is included in one NDA. There are seven patents protecting this drug and one Paragraph IV challenge.

This drug has forty-four patent family members in twenty-three countries.

The generic ingredient in ZORVOLEX is diclofenac. There are forty-seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the diclofenac profile page.

DrugPatentWatch® Generic Entry Outlook for Zorvolex

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be April 23, 2030. This may change due to patent challenges or generic licensing.

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for ZORVOLEX
Drug Prices for ZORVOLEX

See drug prices for ZORVOLEX

Drug Sales Revenue Trends for ZORVOLEX

See drug sales revenues for ZORVOLEX

DrugPatentWatch® Estimated Generic Entry Opportunity Date for ZORVOLEX
Generic Entry Date for ZORVOLEX*:
Constraining patent/regulatory exclusivity:
NDA:
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.

Recent Clinical Trials for ZORVOLEX

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

SponsorPhase
Regeneron PharmaceuticalsPhase 2
Teva Pharmaceutical Industries, Ltd.Phase 2
Regeneron PharmaceuticalsPhase 3

See all ZORVOLEX clinical trials

Paragraph IV (Patent) Challenges for ZORVOLEX
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ZORVOLEX Capsules diclofenac 18 mg and 35 mg 204592 1 2014-06-06

US Patents and Regulatory Information for ZORVOLEX

ZORVOLEX is protected by seven US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of ZORVOLEX is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting ZORVOLEX

Formulation of diclofenac
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Formulation of diclofenac
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF PAIN

Formulation of diclofenac
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Formulation of diclofenac
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Formulation of diclofenac
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF PAIN

Formulation of diclofenac
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Formulation of diclofenac
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF PAIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Zyla ZORVOLEX diclofenac CAPSULE;ORAL 204592-001 Oct 18, 2013 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Zyla ZORVOLEX diclofenac CAPSULE;ORAL 204592-001 Oct 18, 2013 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Zyla ZORVOLEX diclofenac CAPSULE;ORAL 204592-001 Oct 18, 2013 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Zyla ZORVOLEX diclofenac CAPSULE;ORAL 204592-002 Oct 18, 2013 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Zyla ZORVOLEX diclofenac CAPSULE;ORAL 204592-002 Oct 18, 2013 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for ZORVOLEX

When does loss-of-exclusivity occur for ZORVOLEX?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

African Regional IP Organization (ARIPO)

Patent: 74
Estimated Expiration: See Plans and Pricing

Australia

Patent: 10239080
Estimated Expiration: See Plans and Pricing

Patent: 14208310
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 1014272
Estimated Expiration: See Plans and Pricing

Canada

Patent: 59123
Estimated Expiration: See Plans and Pricing

China

Patent: 2438610
Estimated Expiration: See Plans and Pricing

Patent: 4161743
Estimated Expiration: See Plans and Pricing

Patent: 6420667
Estimated Expiration: See Plans and Pricing

Patent: 6727424
Estimated Expiration: See Plans and Pricing

Patent: 6727477
Estimated Expiration: See Plans and Pricing

Colombia

Patent: 70810
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 21525
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 1171285
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 21525
Estimated Expiration: See Plans and Pricing

Patent: 90030
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 02061
Estimated Expiration: See Plans and Pricing

Patent: 31383
Estimated Expiration: See Plans and Pricing

Patent: 52214
Estimated Expiration: See Plans and Pricing

Israel

Patent: 5869
Estimated Expiration: See Plans and Pricing

Japan

Patent: 54846
Estimated Expiration: See Plans and Pricing

Patent: 22924
Estimated Expiration: See Plans and Pricing

Patent: 12524723
Estimated Expiration: See Plans and Pricing

Patent: 15157851
Estimated Expiration: See Plans and Pricing

Malaysia

Patent: 8079
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 7619
Estimated Expiration: See Plans and Pricing

Patent: 7290
Estimated Expiration: See Plans and Pricing

Patent: 11011222
Estimated Expiration: See Plans and Pricing

Morocco

Patent: 295
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 5987
Estimated Expiration: See Plans and Pricing

Patent: 0887
Estimated Expiration: See Plans and Pricing

Patent: 0383
Estimated Expiration: See Plans and Pricing

Philippines

Patent: 015500301
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 5314
Estimated Expiration: See Plans and Pricing

Patent: 201401700X
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 1108650
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1580656
Estimated Expiration: See Plans and Pricing

Patent: 120029398
Estimated Expiration: See Plans and Pricing

Patent: 140124873
Estimated Expiration: See Plans and Pricing

Patent: 150018647
Estimated Expiration: See Plans and Pricing

Patent: 150086563
Estimated Expiration: See Plans and Pricing

Patent: 170002683
Estimated Expiration: See Plans and Pricing

Tunisia

Patent: 11000543
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 6232
Estimated Expiration: See Plans and Pricing

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering ZORVOLEX around the world.

Country Patent Number Title Estimated Expiration
Hong Kong 1231383 雙氯芬酸的新劑型 (A NOVEL FORMULATION OF DICLOFENAC) See Plans and Pricing
South Korea 20140124873 A NOVEL FORMULATION OF DICLOFENAC See Plans and Pricing
Hong Kong 1252214 雙氯芬酸製劑 (DICLOFENAC FORMULATION) See Plans and Pricing
Japan 6222924 See Plans and Pricing
South Africa 201108650 A NOVEL FORMULATION OF DICLOFENAC See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

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McKesson
AstraZeneca
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.