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Last Updated: August 11, 2020

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ABSORICA Drug 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 seven patents protecting this drug and five Paragraph IV challenges.

This drug has twelve patent family members in nine countries.

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

US ANDA 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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Drug patent expirations by year for ABSORICA
Drug Prices for ABSORICA

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Drug Sales Revenue Trends for ABSORICA

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Recent Clinical Trials for ABSORICA

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SponsorPhase
Children's Oncology GroupPhase 2
National Cancer Institute (NCI)Phase 2
Ranbaxy Inc.Phase 4

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Pharmacology for ABSORICA
Drug ClassRetinoid
Paragraph IV (Patent) Challenges for ABSORICA
Tradename Dosage Ingredient NDA Submissiondate
ABSORICA CAPSULE;ORAL isotretinoin 021951 2016-05-16
ABSORICA CAPSULE;ORAL isotretinoin 021951 2015-11-25
ABSORICA CAPSULE;ORAL isotretinoin 021951 2013-06-20
ABSORICA CAPSULE;ORAL isotretinoin 021951 2013-06-19
ABSORICA CAPSULE;ORAL isotretinoin 021951 2013-01-07
ABSORICA CAPSULE;ORAL isotretinoin 021951 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 ABSORICA LD isotretinoin CAPSULE;ORAL 211913-006 Nov 5, 2019 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Sun Pharm ABSORICA LD isotretinoin CAPSULE;ORAL 211913-001 Nov 5, 2019 RX Yes No   Start Trial   Start Trial Y   Start Trial
Sun Pharm Inds Inc ABSORICA isotretinoin CAPSULE;ORAL 021951-004 May 25, 2012 BX RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Sun Pharm ABSORICA LD isotretinoin CAPSULE;ORAL 211913-002 Nov 5, 2019 RX Yes No   Start Trial   Start Trial Y   Start Trial
Sun Pharm Inds Inc ABSORICA isotretinoin CAPSULE;ORAL 021951-004 May 25, 2012 BX RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Sun Pharm Inds Inc ABSORICA isotretinoin CAPSULE;ORAL 021951-001 May 25, 2012 BX RX Yes No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

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