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Serving hundreds of leading biopharmaceutical companies globally:

Colorcon
US Department of Justice
Teva
US Army
Moodys
Daiichi Sankyo
Deloitte
Medtronic
Baxter

Generated: June 19, 2018

DrugPatentWatch Database Preview

Details for Patent: 9,078,925

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Which drugs does patent 9,078,925 protect, and when does it expire?

Patent 9,078,925 protects ABSORICA and is included in one NDA.

This patent has ten patent family members in eight countries.
Summary for Patent: 9,078,925
Title:Pharmaceutical semi-solid composition of isotretinoin
Abstract: The invention relates to an oral pharmaceutical composition of isotretinoin at least two excipients, one of the excipients being a hydrophilic excipient having an HLB value greater than or equal to 10 and the other excipient being an oily vehicle. The oral pharmaceutical composition is substantially devoid of food effect as characterized by a dissolution profile wherein at least 70% of the oral pharmaceutical composition is dissolved after about four hours in a USP2 dissolution apparatus at a paddle speed of 100 rpm, and a dissolution media composed of 900 mL of pH 7.5 buffer containing 0.11% pancreatin, 4.7% cholic acid, 0.14% sodium dihydroxide phosphate and 0.5% sodium hydroxide at 37.degree. C.
Inventor(s): DeBoeck; Arthur M. (Gurabo, PR), Vanderbist; Francis (Brussels, BE), Servais; Cecile (Mehaigne, BE), Baudier; Philippe (Brussels, BE)
Assignee: GALEPHAR PHARMACEUTICAL RESEARCH, INC. (Humacao, PR)
Application Number:14/133,073
Patent Claim Types:
see list of patent claims
Composition; Formulation; Device; Dosage form;

Drugs Protected by US Patent 9,078,925

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Patent Submitted
Sun Pharm Inds Inc ABSORICA isotretinoin CAPSULE;ORAL 021951-001 May 25, 2012 BX RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Sun Pharm Inds Inc ABSORICA isotretinoin CAPSULE;ORAL 021951-002 May 25, 2012 BX RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Sun Pharm Inds Inc ABSORICA isotretinoin CAPSULE;ORAL 021951-005 Aug 15, 2014 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Sun Pharm Inds Inc ABSORICA isotretinoin CAPSULE;ORAL 021951-003 May 25, 2012 BX RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Patent Submitted

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Non-Orange Book US Patents Family Members for Patent 9,078,925

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
9,089,534 Pharmaceutical semi-solid composition of isotretinoin ➤ Sign Up
7,435,427 Pharmaceutical semi-solid composition of isotretinoin ➤ Sign Up
8,952,064 Pharmaceutical semi-solid composition of isotretinoin ➤ Sign Up
8,367,102 Pharmaceutical semi-solid composition of isotretinoin ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Cipla
Julphar
Argus Health
Medtronic
Baxter
Deloitte
Boehringer Ingelheim
Covington
Moodys

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