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Last Updated: November 30, 2022

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.

Drug Prices for isotretinoin

See drug prices for isotretinoin

Recent Clinical Trials for isotretinoin

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

SponsorPhase
Assiut UniversityPhase 4
Children's Hospital Los AngelesPhase 4
United TherapeuticsPhase 4

See all isotretinoin clinical trials

Pharmacology for isotretinoin
Drug ClassRetinoid
Medical Subject Heading (MeSH) Categories 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

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

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

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Serving leading biopharmaceutical companies globally:

Express Scripts
Boehringer Ingelheim
McKesson
Colorcon
Johnson and Johnson
Medtronic

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.