ACCUTANE Drug Patent Profile
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Which patents cover Accutane, and what generic alternatives are available?
Accutane is a drug marketed by Hoffmann La Roche and is included in one NDA.
The generic ingredient in ACCUTANE is isotretinoin. There are thirteen drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the isotretinoin profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Accutane
A generic version of ACCUTANE was approved as isotretinoin by AMNEAL PHARMS NY on September 29th, 2017.
Summary for ACCUTANE
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 73 |
Clinical Trials: | 33 |
Patent Applications: | 7,499 |
Formulation / Manufacturing: | see details |
DailyMed Link: | ACCUTANE at DailyMed |
Recent Clinical Trials for ACCUTANE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Edward Lain, MD | Phase 4 |
Vyne Therapeutics Inc. | Phase 4 |
Children's Oncology Group | Phase 2 |
Anatomical Therapeutic Chemical (ATC) Classes for ACCUTANE
US Patents and Regulatory Information for ACCUTANE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Hoffmann La Roche | ACCUTANE | isotretinoin | CAPSULE;ORAL | 018662-002 | May 7, 1982 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Hoffmann La Roche | ACCUTANE | isotretinoin | CAPSULE;ORAL | 018662-004 | Mar 28, 1983 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Hoffmann La Roche | ACCUTANE | isotretinoin | CAPSULE;ORAL | 018662-003 | May 7, 1982 | DISCN | Yes | No | ⤷ 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 ACCUTANE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Hoffmann La Roche | ACCUTANE | isotretinoin | CAPSULE;ORAL | 018662-003 | May 7, 1982 | ⤷ Try a Trial | ⤷ Try a Trial |
Hoffmann La Roche | ACCUTANE | isotretinoin | CAPSULE;ORAL | 018662-004 | Mar 28, 1983 | ⤷ Try a Trial | ⤷ Try a Trial |
Hoffmann La Roche | ACCUTANE | isotretinoin | CAPSULE;ORAL | 018662-002 | May 7, 1982 | ⤷ Try a Trial | ⤷ Try a Trial |
Hoffmann La Roche | ACCUTANE | isotretinoin | CAPSULE;ORAL | 018662-004 | Mar 28, 1983 | ⤷ Try a Trial | ⤷ Try a Trial |
Hoffmann La Roche | ACCUTANE | isotretinoin | CAPSULE;ORAL | 018662-002 | May 7, 1982 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ACCUTANE
See the table below for patents covering ACCUTANE around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Finland | 63398 | ⤷ Try a Trial | |
Hungary | 184842 | PROCESS FOR PRODUCING NEW 1-BRACKET-1,3-DIOXOLAN-2-Y1-METHYL-BRACKET CLOSED-1H-1,2,4-TRIAZOLE DERIVATIVES | ⤷ Try a Trial |
Netherlands | 7801048 | ⤷ Try a Trial | |
Australia | 521329 | ⤷ Try a Trial | |
Austria | 366683 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |