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Details for Patent: 5,914,322

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Patent 5,914,322 protects SOLARAZE and is included in one NDA. There has been one Paragraph IV challenge on Solaraze. There are five tentative approvals for the compound protected by this patent. Additional details are available via the generic ingredient links below.

This patent has one hundred and eighty-seven patent family members in thirty-three countries.

Summary for Patent: 5,914,322

Title: Treatment of disease and conditions
Abstract:A topically applied transdermally penetrating systemic independent acting pharmaceutical combination and formulation for the treatment of a disease or condition of the skin and exposed tissue for example, basal cell carcinoma, the precancerous, often recurrent, actinic keratoses lesions, fungal lesions, "liver" spots and like lesions (found for the most part in the epidermis), squamous cell tumours, metastatic cancer of the breast to the skin, primary and metastatic melanoma in the skin, genital warts (condyloma acuminata) cervical cancer, and HPV (Human Papilloma Virus) including HPV of the cervix, psoriasis (both plaque-type psoriasis and nail bed psoriasis), corns on the feet and hair loss on the head of pregnant women, comprising, together with pharmaceutical excipients suitable for topical application, a therapeutically effective non-toxic amount of a drug which inhibits prostaglandin synthesis administered with, or carried in, an amount of hyaluronic acid and/or salts thereof and/or homologues, analogues, derivatives, complexes, esters, fragments, and/or sub-units of hyaluronic acid (preferably hyaluronic acid and salts thereof) sufficient to facilitate the drug's penetration through the skin and tissue (including any scar tissue) at the site requiring treatment, to block prostaglandin synthesis.
Inventor(s): Falk; Rudolf Edgar (Toronto, CA), Asculai; Samuel Simon (Toronto, CA)
Assignee: Hyal Pharmaceutical Corporation (Mississauga, CA)
Application Number:08/466,774
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation; Compound;

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Fougera Pharms
SOLARAZE
diclofenac sodium
GEL;TOPICAL021005-001Oct 16, 2000RXYes5,914,322► subscribe
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Foreign Priority and PCT Information for Patent: 5,914,322

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
Canada2061566Feb 20, 1992

Non-Orange Book Patents for Patent: 5,914,322

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
5,824,658 Topical composition containing hyaluronic acid and NSAIDS► subscribe
6,087,344 Formulations containing hyaluronic acid► subscribe
6,136,793 Formulations containing hyaluronic acid► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Patent: 5,914,322

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
African Regional IP Organization (ARIPO)175► subscribe
African Regional IP Organization (ARIPO)448► subscribe
African Regional IP Organization (ARIPO)475► 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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