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Last Updated: October 31, 2020

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 twelve patent family members in nine 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 Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,078,925
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 Submissiondate
Sun Pharm Inds Inc ABSORICA isotretinoin CAPSULE;ORAL 021951-001 May 25, 2012 BX RX Yes No   Start Trial   Start Trial Y   Start Trial
Sun Pharm Inds Inc ABSORICA isotretinoin CAPSULE;ORAL 021951-002 May 25, 2012 BX RX Yes No   Start Trial   Start Trial Y   Start Trial
Sun Pharm Inds Inc ABSORICA isotretinoin CAPSULE;ORAL 021951-005 Aug 15, 2014 RX Yes No   Start Trial   Start Trial Y   Start Trial
Sun Pharm Inds Inc ABSORICA isotretinoin CAPSULE;ORAL 021951-003 May 25, 2012 BX RX Yes No   Start Trial   Start Trial Y   Start Trial
Sun Pharm Inds Inc ABSORICA isotretinoin CAPSULE;ORAL 021951-006 Aug 15, 2014 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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

International Family Members for US Patent 9,078,925

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Austria 270544   Start Trial
Australia 8943801   Start Trial
Brazil 102013032172   Start Trial
Canada 2423170   Start Trial
Canada 2836228   Start Trial
Germany 60104206   Start Trial
European Patent Office 1318791   Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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