ATRALIN Drug Patent Profile
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When do Atralin patents expire, and when can generic versions of Atralin launch?
Atralin is a drug marketed by Dow Pharm and is included in one NDA.
The generic ingredient in ATRALIN is tretinoin. There are twenty-six drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the tretinoin profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Atralin
A generic version of ATRALIN was approved as tretinoin by PADAGIS US on December 24th, 1998.
Summary for ATRALIN
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 3 |
| Raw Ingredient (Bulk) Api Vendors: | 140 |
| Clinical Trials: | 6 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for ATRALIN |
| What excipients (inactive ingredients) are in ATRALIN? | ATRALIN excipients list |
| DailyMed Link: | ATRALIN at DailyMed |
Recent Clinical Trials for ATRALIN
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Zeichner, Joshua, M.D. | Phase 4 |
| Johns Hopkins University | Phase 2 |
| Bausch Health Americas, Inc. | Phase 3 |
Pharmacology for ATRALIN
| Drug Class | Retinoid |
Anatomical Therapeutic Chemical (ATC) Classes for ATRALIN
US Patents and Regulatory Information for ATRALIN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Dow Pharm | ATRALIN | tretinoin | GEL;TOPICAL | 022070-001 | Jul 26, 2007 | AB | 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 ATRALIN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Dow Pharm | ATRALIN | tretinoin | GEL;TOPICAL | 022070-001 | Jul 26, 2007 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ATRALIN
See the table below for patents covering ATRALIN around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Japan | H032118 | HUMECTANT EXCIPIENT FOR TOPICAL APPLICATION OF VITAMIN A ACID | ⤷ Try a Trial |
| European Patent Office | 0393904 | ⤷ Try a Trial | |
| Yugoslavia | 70990 | ⤷ Try a Trial | |
| Hungary | 902444 | ⤷ Try a Trial | |
| Poland | 284811 | ⤷ Try a Trial | |
| Hungary | T53518 | ⤷ Try a Trial | |
| African Intellectual Property Organization (OAPI) | 9739 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ATRALIN
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1304992 | C01304992/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: CLINDAMYCINI PHOSPHAS ET TRETINOINUM; REGISTRATION NO/DATE: SWISSMEDIC 62513 28.03.2014 |
| 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 |
| 1304992 | 2013/044 | Ireland | ⤷ Try a Trial | PRODUCT NAME: CLINDAMYCIN AND TRETINOIN; REGISTRATION NO/DATE: PA1332/043/001 20130322 |
| 0617614 | 2001/009 | Ireland | ⤷ Try a Trial | PRODUCT NAME: PANRETIN-ALITRETINOIN |
| 1304992 | 2013C/060 | Belgium | ⤷ Try a Trial | PRODUCT NAME: CLINDAMYCINE (ALS CLINDAMYCINE FOSFAAT) EN TRETINOINE; AUTHORISATION NUMBER AND DATE: BE437507 20130506 |
| 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 |
| 0617614 | SPC/GB01/014 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: ALITRETINOIN; REGISTERED: UK EU/1/00/149/001 20001018 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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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