Isotretinoin - Generic Drug Details

✉ Email this page to a colleague

What are the generic drug sources for isotretinoin and what is the scope of freedom to operate?

Isotretinoin is the generic ingredient in nine branded drugs marketed by Sun Pharm Inds Inc, Sun Pharm, Hoffmann La Roche, Mylan Pharms Inc, Teva Pharms Usa, Actavis Labs Fl, Amneal Pharms Ny, Aurobindo Pharma, Upsher Smith Labs, Zydus Pharms, Sun Pharm Inds Ltd, and Dr Reddys Labs Ltd, and is included in sixteen NDAs. There are two patents protecting this compound and five Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Isotretinoin has seventeen patent family members in nine countries.

There are thirteen drug master file entries for isotretinoin. Twelve suppliers are listed for this compound.

Summary for isotretinoin

International Patents:	17
US Patents:	2
Tradenames:	9
Applicants:	12
NDAs:	16
Drug Master File Entries:	13
Finished Product Suppliers / Packagers:	12
Raw Ingredient (Bulk) Api Vendors:	73
Clinical Trials:	146
Patent Applications:	7,700
Drug Prices:	Drug price trends for isotretinoin
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for isotretinoin
What excipients (inactive ingredients) are in isotretinoin?	isotretinoin excipients list
DailyMed Link:	isotretinoin at DailyMed

See drug prices for isotretinoin

Recent Clinical Trials for isotretinoin

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Insel Gruppe AG, University Hospital Bern	Phase 2
Chang Gung Memorial Hospital	Phase 1/Phase 2
South Valley University	N/A

See all isotretinoin clinical trials

Pharmacology for isotretinoin

Drug Class	Retinoid

Medical Subject Heading (MeSH) Categories for isotretinoin

Dermatologic Agents
Teratogens

Anatomical Therapeutic Chemical (ATC) Classes for isotretinoin

D10AD	Retinoids for topical use in acne
D10A	ANTI-ACNE PREPARATIONS FOR TOPICAL USE
D10	ANTI-ACNE PREPARATIONS
D	Dermatologicals

D10BA	Retinoids for treatment of acne
D10B	ANTI-ACNE PREPARATIONS FOR SYSTEMIC USE
D10	ANTI-ACNE PREPARATIONS
D	Dermatologicals

Paragraph IV (Patent) Challenges for ISOTRETINOIN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ABSORICA	Capsules	isotretinoin	25 mg	021951	1	2016-05-16
ABSORICA	Capsules	isotretinoin	35 mg	021951	1	2015-11-25
ABSORICA	Capsules	isotretinoin	10 mg	021951	1	2013-06-20
ABSORICA	Capsules	isotretinoin	20 mg	021951	1	2013-01-07
ABSORICA	Capsules	isotretinoin	40 mg	021951	1	2012-12-31

US Patents and Regulatory Information for isotretinoin

+ 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
Zydus Pharms	ISOTRETINOIN	isotretinoin	CAPSULE;ORAL	211568-003	Aug 29, 2023	AB1	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Mylan Pharms Inc	AMNESTEEM	isotretinoin	CAPSULE;ORAL	075945-003	Nov 8, 2002	AB1	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Teva Pharms Usa	CLARAVIS	isotretinoin	CAPSULE;ORAL	076135-001	Apr 11, 2003	AB1	RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Amneal Pharms Ny	ISOTRETINOIN	isotretinoin	CAPSULE;ORAL	207792-001	Sep 29, 2017	AB1	RX	No	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 isotretinoin

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	018662-003	May 7, 1982	⤷ Sign Up	⤷ Sign Up
Sun Pharm Inds Inc	ABSORICA	isotretinoin	CAPSULE;ORAL	021951-003	May 25, 2012	⤷ Sign Up	⤷ Sign Up
Sun Pharm Inds Inc	ABSORICA	isotretinoin	CAPSULE;ORAL	021951-005	Aug 15, 2014	⤷ 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 isotretinoin

Subscribe to access the full database, or Sign Up
Country	Patent Number	Title	Estimated Expiration
Mexico	2017001331	COMPOSICION FARMACEUTICA ORAL DE ISOTRETINOINA. (ORAL PHARMACEUTICAL COMPOSITION OF ISOTRETINOIN.)	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2016016742		⤷ Sign Up
South Africa	201700843	ORAL PHARMACEUTICAL COMPOSITION OF ISOTRETINOIN	⤷ Sign Up
Brazil	112017006779		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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.