ACCUTANE Drug Patent Profile

✉ Email this page to a colleague

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 29^th, 2017.

Sign Up

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:	34
Patent Applications:	7,499
DailyMed Link:	ACCUTANE at DailyMed

Drug patent expirations by year for ACCUTANE

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

See all ACCUTANE clinical trials

US Patents and Regulatory Information for ACCUTANE

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or Sign Up
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

Subscribe to access the full database, or Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
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	018662-004	Mar 28, 1983	⤷ 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.

Subscribe to access the full database, or Sign Up
Country	Patent Number	Title	Estimated Expiration
United Kingdom	1335867		⤷ Sign Up
Ireland	46035	1-(1,3-DIOXOLAN-2-YLMETHYL)-1H-IMIDAZOLES AND 1H-1,2,4-TRIAZOLES	⤷ Sign Up
Hungary	184842	PROCESS FOR PRODUCING NEW 1-BRACKET-1,3-DIOXOLAN-2-Y1-METHYL-BRACKET CLOSED-1H-1,2,4-TRIAZOLE DERIVATIVES	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

AI Research Assistant

Questions you can ask:

Summary for ACCUTANE

Recent Clinical Trials for ACCUTANE

Make Better Decisions: Try a trial or see plans & pricing