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.
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for ACCUTANE?
- What are the global sales for ACCUTANE?
- What is Average Wholesale Price for ACCUTANE?
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 |
![ACCUTANE drug patent expirations Drug patent expirations by year for ACCUTANE](/p/graph/s/t/ACCUTANE-patent-expirations.png)
Recent Clinical Trials for ACCUTANE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Vyne Therapeutics Inc. | Phase 4 |
Edward Lain, MD | Phase 4 |
Children's Oncology Group | Phase 2 |
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Hoffmann La Roche | ACCUTANE | isotretinoin | CAPSULE;ORAL | 018662-004 | Mar 28, 1983 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Hoffmann La Roche | ACCUTANE | isotretinoin | CAPSULE;ORAL | 018662-003 | May 7, 1982 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ 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 ACCUTANE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Hoffmann La Roche | ACCUTANE | isotretinoin | CAPSULE;ORAL | 018662-004 | Mar 28, 1983 | ⤷ Sign Up | ⤷ Sign Up |
Hoffmann La Roche | ACCUTANE | isotretinoin | CAPSULE;ORAL | 018662-004 | Mar 28, 1983 | ⤷ Sign Up | ⤷ Sign Up |
Hoffmann La Roche | ACCUTANE | isotretinoin | CAPSULE;ORAL | 018662-002 | May 7, 1982 | ⤷ Sign Up | ⤷ Sign Up |
Hoffmann La Roche | ACCUTANE | isotretinoin | CAPSULE;ORAL | 018662-004 | Mar 28, 1983 | ⤷ Sign Up | ⤷ Sign Up |
Hoffmann La Roche | ACCUTANE | isotretinoin | CAPSULE;ORAL | 018662-002 | May 7, 1982 | ⤷ Sign Up | ⤷ Sign Up |
Hoffmann La Roche | ACCUTANE | isotretinoin | CAPSULE;ORAL | 018662-004 | Mar 28, 1983 | ⤷ Sign Up | ⤷ Sign Up |
Hoffmann La Roche | ACCUTANE | isotretinoin | CAPSULE;ORAL | 018662-003 | May 7, 1982 | ⤷ Sign Up | ⤷ Sign Up |
>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 |
---|---|---|---|
South Korea | 810000675 | ⤷ Sign Up | |
European Patent Office | 0002533 | USE OF RETINOIDS AS MEDICINES | ⤷ Sign Up |
Finland | 63398 | ⤷ Sign Up | |
Spain | 465981 | ⤷ Sign Up | |
Japan | S5395973 | AZOLE DERIVATIVES | ⤷ Sign Up |
Yugoslavia | 22178 | ⤷ Sign Up | |
Ireland | 35391 | PHARMACEUTICAL PREPARATIONS AND A PROCESS FOR THEIR MANUFACTURE | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |