zoryve Drug Patent Profile
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When do Zoryve patents expire, and when can generic versions of Zoryve launch?
Zoryve is a drug marketed by Arcutis and is included in two NDAs. There are seven 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. Thirteen 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: | 7 |
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 |
![zoryve drug patent expirations Drug patent expirations by year for zoryve](/p/graph/s/t/zoryve-patent-expirations.png)
![Drug Prices for zoryve](/p/graph/drug-price/zoryve.png)
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 twelve US patents and three 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 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 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
Inhibition of crystal growth of roflumilast
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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
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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 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 | 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 | ||||
Arcutis | ZORYVE | roflumilast | CREAM;TOPICAL | 215985-001 | Jul 29, 2022 | 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 | Y | ⤷ Sign Up | |||
Arcutis | ZORYVE | roflumilast | FOAM;TOPICAL | 217242-001 | Dec 15, 2023 | RX | Yes | Yes | ⤷ 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 |
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 |
---|---|---|---|
Japan | 2022547121 | ホスホジエステラーゼ-4阻害剤の投与からの副作用を低減するための方法 | ⤷ Sign Up |
Israel | 271028 | עיכוב גדילת גביש של רופלומילסט (Inhibition of crystal growth of roflumilast) | ⤷ Sign Up |
Mexico | 2022013151 | INHIBICION DEL CRECIMIENTO DE CRISTALES DE ROFLUMILAST. (INHIBITION OF CRYSTAL GROWTH OF ROFLUMILAST.) | ⤷ Sign Up |
Japan | 2024016241 | 抗真菌特性を有する局所用ロフルミラスト製剤 | ⤷ Sign Up |
World Intellectual Property Organization (WIPO) | 2022169615 | ⤷ Sign Up | |
Japan | 6401884 | ⤷ 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 | 34/2010 | Austria | ⤷ Sign Up | PRODUCT NAME: ROFLUMILAST UND DIE SALZE DIESER VERBINDUNG; REGISTRATION NO/DATE: EU/1/10/636/001 - EU/1/10/636/003 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 |
0706513 | SPC/GB10/040 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: ROFLUMILAST, ROFLUMILAST-N-OXIDE AND THE SALTS OF THESE COMPOUNDS.; REGISTERED: UK EU/1/10/636/001 20100705; UK EU/1/10/636/002 20100705; UK EU/1/10/636/003 20100705 |
1606261 | C20100008 00033 | Estonia | ⤷ Sign Up | PRODUCT NAME: DAXAS-ROFLUMILAST; REG NO/DATE: K(2010)4785 05.07.2010 |
1606261 | PA2010010 | Lithuania | ⤷ Sign Up | PRODUCT NAME: ROFLUMILASTUM; REGISTRATION NO/DATE: EU/1/10/636/001-003 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |