ZORVOLEX Drug Patent Profile
✉ Email this page to a colleague
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
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for ZORVOLEX?
- What are the global sales for ZORVOLEX?
- What is Average Wholesale Price for ZORVOLEX?
Summary for ZORVOLEX
| International Patents: | 44 |
| US Patents: | 7 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 114 |
| Clinical Trials: | 2 |
| Patent Applications: | 827 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for ZORVOLEX |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ZORVOLEX |
| What excipients (inactive ingredients) are in ZORVOLEX? | ZORVOLEX excipients list |
| DailyMed Link: | ZORVOLEX at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ZORVOLEX
*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
| Sponsor | Phase |
|---|---|
| Teva Pharmaceutical Industries, Ltd. | Phase 2 |
| Regeneron Pharmaceuticals | Phase 2 |
| Regeneron Pharmaceuticals | Phase 3 |
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 | |||
| >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 | 102438610 | A novel formulation of diclofenac | ⤷ Sign Up |
| China | 104161743 | A novel formulation of diclofenac | ⤷ Sign Up |
| South Korea | 20150086563 | 디클로페낙의 신규 제형 (A NOVEL FORMULATION OF DICLOFENAC) | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
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.
ISSN: 2162-2639
Privacy and Cookies
Terms & Conditions
Site Map
DrugPatentWatch Alternatives
LOE / Major Patent Expirations 2024 - 2025
NCE-1 Patent Challenge Dates 2024 - 2025
Trigger-based marketing for the life sciences
Get DrugPatentWatch Business Intelligence Reports at Amazon.com
DrugChatter - AI-based answers to questions about drugs
RxJam - Digital Marketing for Life Sciences
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2024, www.DrugPatentWatch.com.
See Primary Research Papers Citing DrugPatentWatch
Follow DrugPatentWatch:
