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, Upsher Smith Labs, Douglas Pharms, Sun Pharm Inds Ltd, and Dr Reddys Labs Ltd, and is included in fourteen 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. Nine suppliers are listed for this compound.

Summary for isotretinoin

International Patents:	17
US Patents:	2
Tradenames:	9
Applicants:	11
NDAs:	14
Drug Master File Entries:	13
Finished Product Suppliers / Packagers:	9
Raw Ingredient (Bulk) Api Vendors:	67
Clinical Trials:	140
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
Assiut University	Phase 4
Children's Hospital Los Angeles	Phase 4
United Therapeutics	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
Sun Pharm	ABSORICA LD	isotretinoin	CAPSULE;ORAL	211913-004	Nov 5, 2019		RX	Yes	No	See Plans and Pricing	See Plans and Pricing	Y			See Plans and Pricing
Sun Pharm Inds Ltd	SOTRET	isotretinoin	CAPSULE;ORAL	076041-002	Dec 24, 2002		DISCN	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Teva Pharms Usa	CLARAVIS	isotretinoin	CAPSULE;ORAL	076135-002	Apr 11, 2003	AB1	RX	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Sun Pharm	ABSORICA LD	isotretinoin	CAPSULE;ORAL	211913-005	Nov 5, 2019		DISCN	Yes	No	See Plans and Pricing	See Plans and Pricing	Y			See Plans and Pricing
>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	018662-002	May 7, 1982	See Plans and Pricing	See Plans and Pricing
Hoffmann La Roche	ACCUTANE	isotretinoin	CAPSULE;ORAL	018662-003	May 7, 1982	See Plans and Pricing	See Plans and Pricing
Sun Pharm Inds Inc	ABSORICA	isotretinoin	CAPSULE;ORAL	021951-002	May 25, 2012	See Plans and Pricing	See Plans and Pricing
Sun Pharm Inds Inc	ABSORICA	isotretinoin	CAPSULE;ORAL	021951-002	May 25, 2012	See Plans and Pricing	See Plans and Pricing
>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		See Plans and Pricing
Japan	2017521470	イソトレチノインの経口医薬組成物	See Plans and Pricing
Brazil	112017001963		See Plans and Pricing
World Intellectual Property Organization (WIPO)	2016051288		See Plans and Pricing
>Country	>Patent Number	>Title	>Estimated Expiration

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