ZORVOLEX Drug Patent Profile

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

Summary for ZORVOLEX

International Patents:	44
US Patents:	7
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	114
Clinical Trials:	2
Patent Applications:	5,159
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

See drug prices for ZORVOLEX

See drug sales revenues for ZORVOLEX

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ZORVOLEX

NDA:

204592

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

Sponsor	Phase
Regeneron Pharmaceuticals	Phase 2
Teva Pharmaceutical Industries, Ltd.	Phase 2
Regeneron Pharmaceuticals	Phase 3

See all ZORVOLEX clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for ZORVOLEX

D11AX	Other dermatologicals
D11A	OTHER DERMATOLOGICAL PREPARATIONS
D11	OTHER DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

M01AB	Acetic acid derivatives and related substances
M01A	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
M01	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
M	Musculo-skeletal system

M02AA	Antiinflammatory preparations, non-steroids for topical use
M02A	TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
M02	TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
M	Musculo-skeletal system

S01BC	Antiinflammatory agents, non-steroids
S01B	ANTIINFLAMMATORY AGENTS
S01	OPHTHALMOLOGICALS
S	Sensory organs

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.

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

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
Zyla	ZORVOLEX	diclofenac	CAPSULE;ORAL	204592-001	Oct 18, 2013		DISCN	Yes	No			Y
Zyla	ZORVOLEX	diclofenac	CAPSULE;ORAL	204592-001	Oct 18, 2013		DISCN	Yes	No			Y
Zyla	ZORVOLEX	diclofenac	CAPSULE;ORAL	204592-002	Oct 18, 2013		DISCN	Yes	No			Y

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)

Australia

Brazil

Canada

China

Colombia

Denmark

Eurasian Patent Organization

European Patent Office

Hong Kong

Israel

Japan

Malaysia

Mexico

Morocco

New Zealand

Philippines

Singapore

South Africa

South Korea

Tunisia

Ukraine

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
Mexico	337619	UNA FORMULACION NOVEDOSA DE DICLOFENACO. (A NOVEL FORMULATION OF DICLOFENAC.)
South Korea	101580656
Hong Kong	1231383	雙氯芬酸的新劑型 (A NOVEL FORMULATION OF DICLOFENAC)