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Last Updated: June 28, 2022

ABSORICA Drug Patent Profile


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Which patents cover Absorica, and what generic alternatives are available?

Absorica is a drug marketed by Sun Pharm Inds Inc and Sun Pharm and is included in two NDAs. There are two patents protecting this drug and five Paragraph IV challenges.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Absorica

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

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Paragraph IV (Patent) Challenges for ABSORICA
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 ABSORICA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sun Pharm Inds Inc ABSORICA isotretinoin CAPSULE;ORAL 021951-001 May 25, 2012 AB2 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sun Pharm ABSORICA LD isotretinoin CAPSULE;ORAL 211913-006 Nov 5, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Sun Pharm ABSORICA LD isotretinoin CAPSULE;ORAL 211913-001 Nov 5, 2019 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Sun Pharm Inds Inc ABSORICA isotretinoin CAPSULE;ORAL 021951-003 May 25, 2012 AB2 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sun Pharm ABSORICA LD isotretinoin CAPSULE;ORAL 211913-003 Nov 5, 2019 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Sun Pharm ABSORICA LD isotretinoin CAPSULE;ORAL 211913-001 Nov 5, 2019 RX Yes No See Plans and Pricing See Plans and Pricing Y 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 ABSORICA

International Patents for ABSORICA

See the table below for patents covering ABSORICA around the world.

Country Patent Number Title Estimated Expiration
European Patent Office 1318791 COMPOSITION PHARMACEUTIQUE SEMI-SOLIDE D'ISOTRETINOINE (PHARMACEUTICAL SEMI-SOLID COMPOSITION OF ISOTRETINOIN) See Plans and Pricing
Brazil 102013032172 composição farmacêutica semissólida de isotretinoína See Plans and Pricing
Canada 2423170 COMPOSITION PHARMACEUTIQUE SEMI-SOLIDE D'ISOTRETINOINE (PHARMACEUTICAL SEMI-SOLID COMPOSITION OF ISOTRETINOIN) See Plans and Pricing
Australia 8943801 Pharmaceutical semi-solid composition of isotretinoin See Plans and Pricing
European Patent Office 2964195 COMPOSITION SEMI-SOLIDE PHARMACEUTIQUE D'ISOTRÉTINOÏNE (PHARMACEUTICAL SEMI-SOLID COMPOSITION OF ISOTRETINOIN) See Plans and Pricing
World Intellectual Property Organization (WIPO) 2015094574 See Plans and Pricing
Canada 2836228 COMPOSITION PHARMACEUTIQUE SEMI-SOLIDE D'ISOTRETINOINE (PHARMACEUTICAL SEMI-SOLID COMPOSITION OF ISOTRETINOIN) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
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AstraZeneca
Johnson and Johnson
Mallinckrodt

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