ISOTRETINOIN - Generic Drug Details

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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

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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
Sun Pharm	ABSORICA LD	isotretinoin	CAPSULE;ORAL	211913-004	Nov 5, 2019		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Sun Pharm	ABSORICA LD	isotretinoin	CAPSULE;ORAL	211913-005	Nov 5, 2019		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Actavis Labs Fl	ISOTRETINOIN	isotretinoin	CAPSULE;ORAL	205063-005	Mar 31, 2021	AB2	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Amneal Pharms Ny	ISOTRETINOIN	isotretinoin	CAPSULE;ORAL	207792-003	Sep 29, 2017	AB1	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Mylan Pharms Inc	AMNESTEEM	isotretinoin	CAPSULE;ORAL	075945-002	Nov 8, 2002	AB1	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Aurobindo Pharma	ISOTRETINOIN	isotretinoin	CAPSULE;ORAL	218194-002	Jan 29, 2024	AB2	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Zydus Pharms	ISOTRETINOIN	isotretinoin	CAPSULE;ORAL	211568-001	Aug 29, 2023	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

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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
Sun Pharm Inds Inc	ABSORICA	isotretinoin	CAPSULE;ORAL	021951-001	May 25, 2012	⤷ Sign Up	⤷ Sign Up
Hoffmann La Roche	ACCUTANE	isotretinoin	CAPSULE;ORAL	018662-002	May 7, 1982	⤷ Sign Up	⤷ Sign Up
Sun Pharm Inds Inc	ABSORICA	isotretinoin	CAPSULE;ORAL	021951-004	May 25, 2012	⤷ Sign Up	⤷ Sign Up
Hoffmann La Roche	ACCUTANE	isotretinoin	CAPSULE;ORAL	018662-003	May 7, 1982	⤷ Sign Up	⤷ Sign Up
Sun Pharm Inds Inc	ABSORICA	isotretinoin	CAPSULE;ORAL	021951-005	Aug 15, 2014	⤷ Sign Up	⤷ Sign Up
Sun Pharm Inds Inc	ABSORICA	isotretinoin	CAPSULE;ORAL	021951-006	Aug 15, 2014	⤷ Sign Up	⤷ Sign Up
>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
Canada	2963206		⤷ Sign Up
South Africa	201700843	ORAL PHARMACEUTICAL COMPOSITION OF ISOTRETINOIN	⤷ Sign Up
Brazil	112017006779		⤷ Sign Up
Russian Federation	2017106013		⤷ Sign Up
Brazil	112017001963		⤷ Sign Up
Japan	2017521470	イソトレチノインの経口医薬組成物	⤷ Sign Up
European Patent Office	3200877		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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