ARAZLO Drug Patent Profile
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Which patents cover Arazlo, and what generic alternatives are available?
Arazlo is a drug marketed by Bausch and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.
This drug has thirty-two patent family members in nineteen countries.
The generic ingredient in ARAZLO is tazarotene. There are eight drug master file entries for this compound. Ten 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 SUN PHARMA CANADA on April 3rd, 2017.
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Summary for ARAZLO
| International Patents: | 32 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases 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 three US patents.
| 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 | 11,311,482 | ⤷ Start Trial | ⤷ Start Trial | ||||
| Bausch | ARAZLO | tazarotene | LOTION;TOPICAL | 211882-001 | Dec 18, 2019 | RX | Yes | Yes | 12,128,137 | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| Bausch | ARAZLO | tazarotene | LOTION;TOPICAL | 211882-001 | Dec 18, 2019 | RX | Yes | Yes | 11,679,116 | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for ARAZLO
See the table below for patents covering ARAZLO around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Australia | 2016279801 | ⤷ Start Trial | |
| Brazil | 112017027332 | ⤷ Start Trial | |
| Brazil | 112019023817 | ⤷ Start Trial | |
| Canada | 2988577 | ⤷ Start Trial | |
| Canada | 3063371 | ⤷ Start Trial | |
| China | 108282998 | ⤷ Start Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ARAZLO
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0284288 | SPC/GB98/002 | United Kingdom | ⤷ Start Trial | PRODUCT NAME: TAZAROTENE : ETHYL 6-(2-(4,4-DIMETHYLTHIOCHROMAN-6-YL) ETHYNYL) NICOTINOATE; REGISTERED: DE 37393.00.00 19961203; DE 37393.01.00 19961203; UK 00426/0097 19970730; UK 00426/0096 19970730 |
| 1304992 | 474 | Finland | ⤷ Start Trial | |
| 1304992 | SPC/GB13/061 | United Kingdom | ⤷ Start Trial | PRODUCT NAME: CLINDAMYCIN PHOSPHATE IN COMBINATION WITH TRETINOIN.; REGISTERED: IE PA1332/043/001 20130322; UK PL15142/0249 20130624 |
| 1304992 | CR 2013 00053 | Denmark | ⤷ Start Trial | PRODUCT NAME: CLINDAMYCIN (SOM CLINDAMYCIN PHOSPHATE) OG TRETINOIN; NAT. REG. NO/DATE: 48954 20130416; FIRST REG. NO/DATE: IE PA1332/043/001 20130322 |
| 1304992 | 2013C/060 | Belgium | ⤷ Start Trial | PRODUCT NAME: CLINDAMYCINE (ALS CLINDAMYCINE FOSFAAT) EN TRETINOINE; AUTHORISATION NUMBER AND DATE: BE437507 20130506 |
| 1304992 | 132013902214376 | Italy | ⤷ Start Trial | PRODUCT NAME: CLINDAMICINA FOSFATO E TRETINOINA(ACNATAC); AUTHORISATION NUMBER(S) AND DATE(S): PA1332/043/001, 20130322;042056010/M - 022/M, 20130718 |
| >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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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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