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 are two patents protecting this drug and one Paragraph IV challenge.
This drug has twenty-seven patent family members in nineteen countries.
The generic ingredient in ARAZLO is tazarotene. There are eight drug master file entries for this compound. Eleven 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 on April 3rd, 2017.
Summary for ARAZLO
International Patents: | 27 |
US Patents: | 2 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 129 |
Clinical Trials: | 1 |
Patent Applications: | 4,408 |
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 two US patents.
Patents protecting ARAZLO
Topical compositions and methods for treating skin diseases
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TOPICAL TREATMENT OF ACNE VULGARIS IN PATIENTS 9 YEARS OF AGE AND OLDER
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Bausch | ARAZLO | tazarotene | LOTION;TOPICAL | 211882-001 | Dec 18, 2019 | 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 |
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 | ⤷ Sign Up | ⤷ Sign Up |
>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 |
---|---|---|---|
Slovenia | 2052714 | ⤷ Sign Up | |
South Korea | 100840169 | ⤷ Sign Up | |
Russian Federation | 2251410 | СИСТЕМА ДОСТАВКИ В ВИДЕ ГЕЛЯ ДЛЯ МЕСТНОГО ПРИМЕНЕНИЯ (DELIVERY SYSTEM IN THE FORM OF GEL FOR LOCAL APPLICATION) | ⤷ Sign Up |
Denmark | 3310389 | ⤷ Sign Up | |
Japan | 2004505900 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ARAZLO
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1304992 | 474 | Finland | ⤷ Sign Up | |
1304992 | PA2013025,C1304992 | Lithuania | ⤷ Sign Up | PRODUCT NAME: CLINDAMYCINUM + TRETINOINUM; REGISTRATION NO/DATE: LT/1/13/3279/001, 2013 04 26 LT/1/13/3279/002, 2013 04 26 PA1332/043/001 20130323 |
1304992 | PA2013025 | Lithuania | ⤷ Sign Up | PRODUCT NAME: CLINFAMYCINUM + TRETINOINUM; REGISTRATION NO/DATE: LT/1/13/3279/001, 2013 04 26 LT/1/13/3279/002, 2013 04 26 PA1332/043/001 20130323 |
1304992 | 2013C/060 | Belgium | ⤷ Sign Up | PRODUCT NAME: CLINDAMYCINE (ALS CLINDAMYCINE FOSFAAT) EN TRETINOINE; AUTHORISATION NUMBER AND DATE: BE437507 20130506 |
1304992 | SPC/GB13/061 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: CLINDAMYCIN PHOSPHATE IN COMBINATION WITH TRETINOIN.; REGISTERED: IE PA1332/043/001 20130322; UK PL15142/0249 20130624 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |