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Last Updated: April 26, 2024

Isotretinoin - Generic Drug Details

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What are the generic 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:	143
Patent Applications:	7,700
Formulation / Manufacturing:	see details
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
South Valley University	N/A
Tanta University	Phase 4
Assiut University	Phase 4

See all isotretinoin clinical trials

Pharmacology for isotretinoin

Drug Class	Retinoid

Medical Subject Heading (MeSH) Categories for isotretinoin

Dermatologic Agents
Teratogens

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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Glossary

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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	211568-001	Aug 29, 2023	AB1	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Teva Pharms Usa	CLARAVIS	isotretinoin	CAPSULE;ORAL	076135-001	Apr 11, 2003	AB1	RX	No	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Zydus Pharms	ISOTRETINOIN	isotretinoin	CAPSULE;ORAL	211568-002	Aug 29, 2023	AB1	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Aurobindo Pharma	ISOTRETINOIN	isotretinoin	CAPSULE;ORAL	218194-002	Jan 29, 2024	AB2	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Upsher Smith Labs	ISOTRETINOIN	isotretinoin	CAPSULE;ORAL	212333-001	Sep 21, 2021	AB2	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Aurobindo Pharma	ISOTRETINOIN	isotretinoin	CAPSULE;ORAL	218194-003	Jan 29, 2024	AB2	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Sun Pharm Inds Inc	ABSORICA	isotretinoin	CAPSULE;ORAL	021951-001	May 25, 2012	AB2	RX	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 isotretinoin

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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
Sun Pharm Inds Inc	ABSORICA	isotretinoin	CAPSULE;ORAL	021951-006	Aug 15, 2014	⤷ Try a Trial	⤷ Try a Trial
Sun Pharm Inds Inc	ABSORICA	isotretinoin	CAPSULE;ORAL	021951-006	Aug 15, 2014	⤷ Try a Trial	⤷ Try a Trial
Sun Pharm Inds Inc	ABSORICA	isotretinoin	CAPSULE;ORAL	021951-002	May 25, 2012	⤷ Try a Trial	⤷ Try a Trial
Sun Pharm Inds Inc	ABSORICA	isotretinoin	CAPSULE;ORAL	021951-002	May 25, 2012	⤷ Try a Trial	⤷ Try a Trial
Sun Pharm Inds Inc	ABSORICA	isotretinoin	CAPSULE;ORAL	021951-001	May 25, 2012	⤷ Try a Trial	⤷ Try a Trial
Sun Pharm Inds Inc	ABSORICA	isotretinoin	CAPSULE;ORAL	021951-006	Aug 15, 2014	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for isotretinoin

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Country	Patent Number	Title	Estimated Expiration
Australia	2015294993		⤷ Try a Trial
Australia	2015326489		⤷ Try a Trial
Canada	2963206		⤷ Try a Trial
European Patent Office	3200877		⤷ Try a Trial
Mexico	2017004312	COMPOSICION FARMACEUTICA ORAL DE BAJA DOSIS DE ISOTRETINOINA. (LOW DOSE ORAL PHARMACEUTICAL COMPOSITION OF ISOTRETINOIN.)	⤷ Try a Trial
Japan	2017521470	イソトレチノインの経口医薬組成物	⤷ Try a Trial
Japan	2017530149	低用量経口イソトレチノイン医薬組成物	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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