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Last Updated: November 22, 2024

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. 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.

There are four tentative approvals for the generic drug (diclofenac), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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Drug patent expirations by year for ZORVOLEX
Drug Prices for ZORVOLEX

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Drug Sales Revenue Trends for ZORVOLEX

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DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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
Teva Pharmaceutical Industries, Ltd.Phase 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 ⤷  Sign Up.

This potential generic entry date is based on patent ⤷  Sign Up.

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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Formulation of diclofenac
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF PAIN

Formulation of diclofenac
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Formulation of diclofenac
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Formulation of diclofenac
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF PAIN

Formulation of diclofenac
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Formulation of diclofenac
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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 ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Zyla ZORVOLEX diclofenac CAPSULE;ORAL 204592-001 Oct 18, 2013 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Zyla ZORVOLEX diclofenac CAPSULE;ORAL 204592-001 Oct 18, 2013 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Zyla ZORVOLEX diclofenac CAPSULE;ORAL 204592-002 Oct 18, 2013 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Zyla ZORVOLEX diclofenac CAPSULE;ORAL 204592-002 Oct 18, 2013 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Zyla ZORVOLEX diclofenac CAPSULE;ORAL 204592-002 Oct 18, 2013 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Zyla ZORVOLEX diclofenac CAPSULE;ORAL 204592-001 Oct 18, 2013 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

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
Patent: A NOVEL FORMULATION OF DICLOFENAC
Estimated Expiration: ⤷  Sign Up

Australia

Patent: 10239080
Patent: A novel formulation of diclofenac
Estimated Expiration: ⤷  Sign Up

Patent: 14208310
Patent: A Novel Formulation of Diclofenac
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 1014272
Patent: nova formulação de diclofenac
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 59123
Patent: NOUVELLE FORMULATION DE DICLOFENAC (A NOVEL FORMULATION OF DICLOFENAC)
Estimated Expiration: ⤷  Sign Up

China

Patent: 2438610
Patent: A novel formulation of diclofenac
Estimated Expiration: ⤷  Sign Up

Patent: 4161743
Patent: A novel formulation of diclofenac
Estimated Expiration: ⤷  Sign Up

Patent: 6420667
Patent: 双氯芬酸的新剂型 (A novel formulation of diclofenac)
Estimated Expiration: ⤷  Sign Up

Patent: 6727424
Patent: 双氯芬酸的新剂型 (A novel formulation of diclofenac)
Estimated Expiration: ⤷  Sign Up

Patent: 6727477
Patent: 双氯芬酸的新剂型 (A new formation of diclofenac)
Estimated Expiration: ⤷  Sign Up

Colombia

Patent: 70810
Patent: UNA FORMULACIÓN NOVEDOSA DE DICLOFENACO
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 21525
Estimated Expiration: ⤷  Sign Up

Eurasian Patent Organization

Patent: 1171285
Patent: НОВАЯ ТЕХНОЛОГИЯ ИЗГОТОВЛЕНИЯ ДИКЛОФЕНАКА
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 21525
Patent: FORMULATION DE DICLOFÉNAC (DICLOFENAC FORMULATION)
Estimated Expiration: ⤷  Sign Up

Patent: 90030
Patent: FORMULATION DE DICLOFÉNAC (DICLOFENAC FORMULATION)
Estimated Expiration: ⤷  Sign Up

Hong Kong

Patent: 02061
Patent: 雙氯芬酸的新劑型 (A NOVEL FORMULATION OF DICLOFENAC)
Estimated Expiration: ⤷  Sign Up

Patent: 31383
Patent: 雙氯芬酸的新劑型 (A NOVEL FORMULATION OF DICLOFENAC)
Estimated Expiration: ⤷  Sign Up

Patent: 52214
Patent: 雙氯芬酸製劑 (DICLOFENAC FORMULATION)
Estimated Expiration: ⤷  Sign Up

Israel

Patent: 5869
Patent: פורמולציה חדשה של דיקלופנאק (A novel formulation of diclofenac)
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 54846
Estimated Expiration: ⤷  Sign Up

Patent: 22924
Estimated Expiration: ⤷  Sign Up

Patent: 12524723
Estimated Expiration: ⤷  Sign Up

Patent: 15157851
Patent: ジクロフェナクの新規製剤 (NOVEL FORMULATION OF DICLOFENAC)
Estimated Expiration: ⤷  Sign Up

Malaysia

Patent: 8079
Patent: A NOVEL FORMULATION OF DICLOFENAC
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 7619
Patent: UNA FORMULACION NOVEDOSA DE DICLOFENACO. (A NOVEL FORMULATION OF DICLOFENAC.)
Estimated Expiration: ⤷  Sign Up

Patent: 7290
Patent: UNA FORMULACION NOVEDOSA DE DICLOFENACO. (A NOVEL FORMULATION OF DICLOFENAC.)
Estimated Expiration: ⤷  Sign Up

Patent: 11011222
Patent: UNA FORMULACION NOVEDOSA DE DICLOFENACO. (A NOVEL FORMULATION OF DICLOFENAC.)
Estimated Expiration: ⤷  Sign Up

Morocco

Patent: 295
Patent: صيغة جديدة لديكلوفيناك
Estimated Expiration: ⤷  Sign Up

New Zealand

Patent: 5987
Patent: A novel formulation of diclofenac
Estimated Expiration: ⤷  Sign Up

Patent: 0887
Patent: A novel formulation of diclofenac
Estimated Expiration: ⤷  Sign Up

Patent: 0383
Patent: A novel formulation of diclofenac
Estimated Expiration: ⤷  Sign Up

Philippines

Patent: 015500301
Patent: A NOVEL FORMULATION OF DICLOFENAC
Estimated Expiration: ⤷  Sign Up

Singapore

Patent: 5314
Patent: A NOVEL FORMULATION OF DICLOFENAC
Estimated Expiration: ⤷  Sign Up

Patent: 201401700X
Patent: A NOVEL FORMULATION OF DICLOFENAC
Estimated Expiration: ⤷  Sign Up

South Africa

Patent: 1108650
Patent: A NOVEL FORMULATION OF DICLOFENAC
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 1580656
Estimated Expiration: ⤷  Sign Up

Patent: 120029398
Patent: A NOVEL FORMULATION OF DICLOFENAC
Estimated Expiration: ⤷  Sign Up

Patent: 140124873
Patent: A NOVEL FORMULATION OF DICLOFENAC
Estimated Expiration: ⤷  Sign Up

Patent: 150018647
Patent: A NOVEL FORMULATION OF NAPROXEN
Estimated Expiration: ⤷  Sign Up

Patent: 150086563
Patent: 디클로페낙의 신규 제형 (A NOVEL FORMULATION OF DICLOFENAC)
Estimated Expiration: ⤷  Sign Up

Patent: 170002683
Patent: 디클로페낙의 신규 제형 (A NOVEL FORMULATION OF DICLOFENAC)
Estimated Expiration: ⤷  Sign Up

Tunisia

Patent: 11000543
Patent: A NOVEL FORMULATION OF DICLOFENAC
Estimated Expiration: ⤷  Sign Up

Ukraine

Patent: 6232
Patent: РАЗОВАЯ ДОЗА ФАРМАЦЕВТИЧЕСКОЙ КОМПОЗИЦИИ ДИКЛОФЕНАКА (ВАРИАНТЫ);РАЗОВА ДОЗА ФАРМАЦЕВТИЧНОЇ КОМПОЗИЦІЇ ДИКЛОФЕНАКУ (ВАРІАНТИ) (UNIT DOSE OF DICLOFENAC-CONTAINING COMPOSITION)
Estimated Expiration: ⤷  Sign Up

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
China 104161743 A novel formulation of diclofenac ⤷  Sign Up
Singapore 10201401700X A NOVEL FORMULATION OF DICLOFENAC ⤷  Sign Up
Mexico 337619 UNA FORMULACION NOVEDOSA DE DICLOFENACO. (A NOVEL FORMULATION OF DICLOFENAC.) ⤷  Sign Up
Singapore 175314 A NOVEL FORMULATION OF DICLOFENAC ⤷  Sign Up
Japan 6222924 ⤷  Sign Up
Japan 6154846 ⤷  Sign Up
Japan 2015157851 ジクロフェナクの新規製剤 (NOVEL FORMULATION OF DICLOFENAC) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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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.