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ABSORICA Drug Profile

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Absorica is a drug marketed by Ranbaxy and is included in one NDA. It is available from one supplier. There are five patents protecting this drug and three Paragraph IV challenges.

This drug has ten patent family members in eight countries.

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

Summary for Tradename: ABSORICA

Suppliers / Packagers: see list1
Bulk Api Vendors: see list37
Clinical Trials: see list1
Formulation / Manufacturing:see details
Drug Prices:see details

Pharmacology for Tradename: ABSORICA

Drug ClassRetinoid
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
CAPSULE;ORAL021951-004May 25, 2012RXYes8,952,064► subscribeY ► subscribe
CAPSULE;ORAL021951-004May 25, 2012RXYes7,435,427► subscribeY ► subscribe
CAPSULE;ORAL021951-001May 25, 2012RXNo8,367,102► subscribe ► subscribe
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Paragraph IV activity for: ABSORICA

Drugname Dosage Strength RLD Submissiondate
isotretinoinCapsules30 mg and 40 mgAbsorica12/31/2012
isotretinoinCapsules20 mgAbsorica6/19/2013
isotretinoinCapsules20 mgAbsorica1/7/2013

International Patent Family for Tradename: ABSORICA

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO)2015094574► subscribe
Canada2836228► subscribe
Australia8943801► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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