ARAZLO Drug Patent Profile
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Which patents cover Arazlo, and when can generic versions of Arazlo launch?
Arazlo is a drug marketed by Bausch and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.
This drug has twenty-four patent family members in eighteen countries.
The generic ingredient in ARAZLO is tazarotene. There are eight drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the tazarotene profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Arazlo
A generic version of ARAZLO was approved as tazarotene by TARO PHARMS on April 3rd, 2017.
Summary for ARAZLO
International Patents: | 24 |
US Patents: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 128 |
Clinical Trials: | 1 |
Patent Applications: | 5,152 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for ARAZLO |
What excipients (inactive ingredients) are in ARAZLO? | ARAZLO excipients list |
DailyMed Link: | ARAZLO at DailyMed |


Recent Clinical Trials for ARAZLO
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Dr. Emmy Graber | Phase 4 |
Pharmacology for ARAZLO
Drug Class | Retinoid |
Anatomical Therapeutic Chemical (ATC) Classes for ARAZLO
Paragraph IV (Patent) Challenges for ARAZLO
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
ARAZLO | Topical Lotion | tazarotene | 0.045% | 211882 | 1 | 2022-05-12 |
US Patents and Regulatory Information for ARAZLO
ARAZLO is protected by one US patents and one FDA Regulatory Exclusivity.
Patents protecting ARAZLO
Topical compositions and methods for treating skin diseases
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TOPICAL TREATMENT OF ACNE VULGARIS IN PATIENTS 9 YEARS OF AGE AND OLDER
FDA Regulatory Exclusivity protecting ARAZLO
NEW PRODUCT
Exclusivity Expiration: ⤷ Try a Trial
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Bausch | ARAZLO | tazarotene | LOTION;TOPICAL | 211882-001 | Dec 18, 2019 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Bausch | ARAZLO | tazarotene | LOTION;TOPICAL | 211882-001 | Dec 18, 2019 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for ARAZLO
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Bausch | ARAZLO | tazarotene | LOTION;TOPICAL | 211882-001 | Dec 18, 2019 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ARAZLO
See the table below for patents covering ARAZLO around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Hungary | E050603 | ⤷ Try a Trial | |
Denmark | 1304992 | ⤷ Try a Trial | |
Denmark | 3310389 | ⤷ Try a Trial | |
South Africa | 200301037 | Topical gel delivery system. | ⤷ Try a Trial |
Brazil | 112017027332 | composições tópicas que compreendem um corticosteróide e um retinóide para tratar psoríase. | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ARAZLO
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1304992 | 132013902214376 | Italy | ⤷ Try a Trial | PRODUCT NAME: CLINDAMICINA FOSFATO E TRETINOINA(ACNATAC); AUTHORISATION NUMBER(S) AND DATE(S): PA1332/043/001, 20130322;042056010/M - 022/M, 20130718 |
1304992 | 2013/044 | Ireland | ⤷ Try a Trial | PRODUCT NAME: CLINDAMYCIN AND TRETINOIN; REGISTRATION NO/DATE: PA1332/043/001 20130322 |
0284288 | 12/1998 | Austria | ⤷ Try a Trial | PRODUCT NAME: TAZAROTENE; NAT. REGISTRATION NO/DATE: 1-22102, 1-22103 19970918; FIRST REGISTRATION: DE 37393.00.00, 37393.01.00 19961203 |
0031058 | 98C0008 | Belgium | ⤷ Try a Trial | PRODUCT NAME: TAZAROTENE; NAT. REGISTRATION NO/DATE: NL22604 19970922; FIRST REGISTRATION: DE - 37393.00.00 19961203 |
1304992 | CR 2013 00053 | Denmark | ⤷ Try a Trial | PRODUCT NAME: CLINDAMYCIN (SOM CLINDAMYCIN PHOSPHATE) OG TRETINOIN; NAT. REG. NO/DATE: 48954 20130416; FIRST REG. NO/DATE: IE PA1332/043/001 20130322 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |