ZORYVE Drug Patent Profile
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Which patents cover Zoryve, and when can generic versions of Zoryve launch?
Zoryve is a drug marketed by Arcutis and is included in two NDAs. There are thirteen patents protecting this drug and one Paragraph IV challenge.
This drug has forty-eight patent family members in thirteen countries.
The generic ingredient in ZORYVE is roflumilast. There are ten drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the roflumilast profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Zoryve
A generic version of ZORYVE was approved as roflumilast by MYLAN on July 13th, 2018.
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Summary for ZORYVE
| International Patents: | 48 |
| US Patents: | 13 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 135 |
| Clinical Trials: | 1 |
| Patent Applications: | 5,683 |
| Drug Prices: | Drug price information for ZORYVE |
| What excipients (inactive ingredients) are in ZORYVE? | ZORYVE excipients list |
| DailyMed Link: | ZORYVE at DailyMed |
Recent Clinical Trials for ZORYVE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Padagis LLC | Phase 3 |
Pharmacology for ZORYVE
| Drug Class | Phosphodiesterase 4 Inhibitor |
| Mechanism of Action | Phosphodiesterase 4 Inhibitors |
Paragraph IV (Patent) Challenges for ZORYVE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| ZORYVE | Cream | roflumilast | 0.3% | 215985 | 1 | 2023-12-27 |
US Patents and Regulatory Information for ZORYVE
ZORYVE is protected by twenty-five US patents and four FDA Regulatory Exclusivities.
Patents protecting ZORYVE
Inhibition of crystal growth of roflumilast
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Topical roflumilast formulation having improved delivery and plasma half life
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Patented Use: TOPICAL TREATMENT OF MILD TO MODERATE ATOPIC DERMATITIS
Topical roflumilast formulation having improved delivery and plasma half life
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Patented Use: TOPICAL TREATMENT OF PLAQUE PSORIASIS, INCLUDING INTERTRIGINOUS AREAS, IN PATIENTS 6 YEARS OF AGE OR OLDER
Topical roflumilast formulation having improved delivery and plasma half life
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Patented Use: TOPICAL TREATMENT OF PLAQUE PSORIASIS, INCLUDING INTERTRIGINOUS AREAS, IN PATIENTS 12 YEARS OF AGE AND OLDER. (1)
Topical roflumilast formulation having improved delivery and plasma half life
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Patented Use: TOPICAL TREATMENT OF SEBORRHEIC DERMATITIS IN PATIENTS 9 YEARS OF AGE AND OLDER
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Patented Use: TOPICAL TREATMENT OF SEBORRHEIC DERMATITIS IN PATIENTS 9 YEARS OF AGE AND OLDER
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Patented Use: TOPICAL TREATMENT OF MILD TO MODERATE ATOPIC DERMATITIS
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Patented Use: TOPICAL TREATMENT OF PLAQUE PSORIASIS, INCLUDING INTERTRIGINOUS AREAS, IN PATIENTS 6 YEARS OF AGE AND OLDER
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Patented Use: TOPICAL TREATMENT OF SEBORRHEIC DERMATITIS IN PATIENTS 9 YEARS OF AGE AND OLDER
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Patented Use: TOPICAL TREATMENT OF MILD TO MODERATE ATOPIC DERMATITIS
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Patented Use: TOPICAL TREATMENT OF PLAQUE PSORIASIS, INCLUDING INTERTRIGINOUS AREAS, IN PATIENTS 6 YEARS OF AGE AND OLDER
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Patented Use: TOPICAL TREATMENT OF SEBORRHEIC DERMATITIS IN PATIENTS 9 YEARS OF AGE AND OLDER
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Patented Use: TOPICAL TREATMENT OF MILD TO MODERATE ATOPIC DERMATITIS
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Patent Expiration: ⤷ Sign Up
Patented Use: TOPICAL TREATMENT OF PLAQUE PSORIASIS, INCLUDING INTERTRIGINOUS AREAS, IN PATIENTS 6 YEARS OF AGE AND OLDER
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Patented Use: TOPICAL TREATMENT OF SEBORRHEIC DERMATITIS IN PATIENTS 9 YEARS OF AGE AND OLDER
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Inhibition of crystal growth of roflumilast
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Patent Expiration: ⤷ Sign Up
Inhibition of crystal growth of roflumilast
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TOPICAL TREATMENT OF MILD TO MODERATE ATOPIC DERMATITIS
Inhibition of crystal growth of roflumilast
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TOPICAL TREATMENT OF PLAQUE PSORIASIS, INCLUDING INTERTRIGINOUS AREAS, IN PATIENTS 6 YEARS OF AGE OR OLDER
Inhibition of crystal growth of roflumilast
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TOPICAL TREATMENT OF PLAQUE PSORIASIS, INCLUDING INTERTRIGINOUS AREAS, IN PATIENTS 12 YEARS OF AGE AND OLDER. (1)
Inhibition of crystal growth of roflumilast
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Patent Expiration: ⤷ Sign Up
Patented Use: TOPICAL TREATMENT OF SEBORRHEIC DERMATITIS IN PATIENTS 9 YEARS OF AGE AND OLDER
FDA Regulatory Exclusivity protecting ZORYVE
NEW STRENGTH
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NEW PATIENT POPULATION
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NEW PRODUCT
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NEW PRODUCT
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Arcutis | ZORYVE | roflumilast | FOAM;TOPICAL | 217242-001 | Dec 15, 2023 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Arcutis | ZORYVE | roflumilast | FOAM;TOPICAL | 217242-001 | Dec 15, 2023 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Arcutis | ZORYVE | roflumilast | CREAM;TOPICAL | 215985-001 | Jul 29, 2022 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Arcutis | ZORYVE | roflumilast | FOAM;TOPICAL | 217242-001 | Dec 15, 2023 | RX | Yes | Yes | ⤷ 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 |
EU/EMA Drug Approvals for ZORYVE
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| AstraZeneca AB | Daxas | roflumilast | EMEA/H/C/001179 Daxas is indicated for maintenance treatment of severe chronic obstructive pulmonary disease (COPD) (FEV1 post-bronchodilator less than 50% predicted) associated with chronic bronchitis in adult patients with a history of frequent exacerbations as add-on to bronchodilator treatment., |
Authorised | no | no | no | 2010-07-05 | |
| AstraZeneca AB | Libertek | roflumilast | EMEA/H/C/002399 Libertek is indicated for maintenance treatment of severe chronic obstructive pulmonary disease (COPD) (FEV1 post-bronchodilator less than 50% predicted) associated with chronic bronchitis in adult patients with a history of frequent exacerbations as add-on to bronchodilator treatment. |
Withdrawn | no | no | no | 2011-02-28 | |
| AstraZeneca AB | Daliresp | roflumilast | EMEA/H/C/002398 Daliresp is indicated for maintenance treatment of severe chronic obstructive pulmonary disease (COPD) (FEV1 post-bronchodilator less than 50% predicted) associated with chronic bronchitis in adult patients with a history of frequent exacerbations as add-on to bronchodilator treatment. |
Withdrawn | no | no | no | 2011-02-28 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for ZORYVE
See the table below for patents covering ZORYVE around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Canada | 3166300 | FORMULATION DE ROFLUMILAST TOPIQUE AYANT UNE ADMINISTRATION ET UNE DEMI-VIE PLASMATIQUE AMELIOREES (TOPICAL ROFLUMILAST FORMULATION HAVING IMPROVED DELIVERY AND PLASMA HALF-LIFE) | ⤷ Sign Up |
| World Intellectual Property Organization (WIPO) | 2021045804 | ⤷ Sign Up | |
| South Korea | 20200016940 | 로플루밀라스트의 결정 성장의 저해 | ⤷ Sign Up |
| Japan | 7386353 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ZORYVE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0706513 | 1090034-8 | Sweden | ⤷ Sign Up | PRODUCT NAME: ROFLUMILAST OCH SALTER DAERAV; REG. NO/DATE: EU/1/10/636/001 20100705 |
| 1606261 | C 2010 014 | Romania | ⤷ Sign Up | PRODUCT NAME: ROFLUMILAST; NATIONAL AUTHORISATION NUMBER: RO EU/1/10/636/001, RO EU/1/10/636/002, RO EU/1/10/636/003; DATE OF NATIONAL AUTHORISATION: 20100705; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/10/636/001, EMEA EU/1/10/636/002, EMEA EU/1/10/636/003; DATE OF FIRST AUTHORISATION IN EEA: 20100705 |
| 1606261 | PA2010010 | Lithuania | ⤷ Sign Up | PRODUCT NAME: ROFLUMILASTUM; REGISTRATION NO/DATE: EU/1/10/636/001-003 20100705 |
| 0706513 | 10C0052 | France | ⤷ Sign Up | PRODUCT NAME: ROFLUMILAST, ROFLUMILAST-N-OXYDE ET LES SELS DE CES COMPOSES; NAT. REGISTRATION NO/DATE: EU/1/16/636/001 20100705; FIRST REGISTRATION: EU/1/10/636/001 20100705 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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.
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