Details for Patent: 9,078,925
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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 |
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>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 |
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Austria | E270544 | ⤷ Sign Up | |||
Australia | 8943801 | ⤷ Sign Up | |||
Brazil | 102013032172 | ⤷ Sign Up | |||
Canada | 2423170 | ⤷ Sign Up | |||
Canada | 2836228 | ⤷ Sign Up | |||
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