Last Updated: August 2, 2026

ISOTRETINOIN Drug Patent Profile

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Which patents cover Isotretinoin, and when can generic versions of Isotretinoin launch?

Isotretinoin is a drug marketed by Actavis Labs Fl, Amneal Pharms Ny, Aurobindo Pharma, Upsher Smith Labs, and Zydus Pharms. and is included in eight NDAs.

The generic ingredient in ISOTRETINOIN is isotretinoin. There are thirteen drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the isotretinoin profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Isotretinoin

A generic version of ISOTRETINOIN was approved as isotretinoin by AMNEAL PHARMS NY on September 29^th, 2017.

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Summary for ISOTRETINOIN

US Patents:	0
Applicants:	5
NDAs:	8
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ISOTRETINOIN

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

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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	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Zydus Pharms	ISOTRETINOIN	isotretinoin	CAPSULE;ORAL	216633-001	May 22, 2025	AB2	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Zydus Pharms	ISOTRETINOIN	isotretinoin	CAPSULE;ORAL	216633-004	May 22, 2025	AB2	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Zydus Pharms	ISOTRETINOIN	isotretinoin	CAPSULE;ORAL	211568-002	Aug 29, 2023	AB1	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

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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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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.