Generic player Impax Lab confirmed (in a press release Here ) that it has initiated a Paragraph IV patent challenge to patents listed in the Orange book by innovator M/S Galderma Labs for Doxycycline 40 mg DR capsules (Oracea).
Following patents are listed in Orange Book for Doxycycline 40 mg DR capsules (Oracea):
US5789395 (Expiry: Aug 30, 2016): Which covers a method for inhibiting nitric oxide production in a mammal system, comprising providing to the mammalian system an amount of a tetracycline compound sufficient to cause a decrease in the amount of nitric oxide produced endogenously by the mammalian-system.
US5919775 (Expiry: Aug 30, 2016): Which covers a method of inhibiting expression of inducible nitric oxide synthase in a mammal system, comprising administering to said mammal system an amount of a tetracycline compound sufficient to inhibit inducible nitric oxide synthase expression in said mammal system
US7211267 (Expiry: Apr 5, 2022): Which covers a method of treating acne in a human in need thereof comprising administering orally or intravenously to said human an antibiotic tetracycline compound in a sub-antibacterial amount that reduces lesion count, said amount being 10 80% of the antibacterial effective amount, wherein the tetracycline compound is administered long term, without administering a bisphosphonate compound.
US7232572 (Expiry: Apr 5, 2022): Which covers a method for treating papules and pustules of rosacea in a human in need thereof comprising administering orally to said human a tetracycline compound, or a pharmaceutically acceptable salt thereof, in an amount that is effective to treat the papules and pustules of rosacea, but has substantially no antibiotic activity, said amount being 10-80% of the antibiotic amount, wherein the tetracycline compound is an antibiotic tetracycline compound or a pharmaceutically acceptable salt thereof administered in an amount that results in no reduction of skin microflora during a six-month treatment, without administering a bisphosphonate compound.
US5919775 (Expiry: Aug 30, 2016): Which covers a method of inhibiting expression of inducible nitric oxide synthase in a mammal system, comprising administering to said mammal system an amount of a tetracycline compound sufficient to inhibit inducible nitric oxide synthase expression in said mammal system
US7211267 (Expiry: Apr 5, 2022): Which covers a method of treating acne in a human in need thereof comprising administering orally or intravenously to said human an antibiotic tetracycline compound in a sub-antibacterial amount that reduces lesion count, said amount being 10 80% of the antibacterial effective amount, wherein the tetracycline compound is administered long term, without administering a bisphosphonate compound.
US7232572 (Expiry: Apr 5, 2022): Which covers a method for treating papules and pustules of rosacea in a human in need thereof comprising administering orally to said human a tetracycline compound, or a pharmaceutically acceptable salt thereof, in an amount that is effective to treat the papules and pustules of rosacea, but has substantially no antibiotic activity, said amount being 10-80% of the antibiotic amount, wherein the tetracycline compound is an antibiotic tetracycline compound or a pharmaceutically acceptable salt thereof administered in an amount that results in no reduction of skin microflora during a six-month treatment, without administering a bisphosphonate compound.
The ’775 and ‘267 patents are assigned to The Research Foundation of State University of New York (Albany, NY) and Hospital for Joint Diseases (New York, NY). The ‘267 and ‘572 patents are assigned to CollaGenex Pharmaceuticals. Innovator has licensing agreement with the assignees of these patents.
After the receipt of Paragraph IV notice letter of Impax by innovator, subsequently, on September 18, 2009, the assignee of the patent/innovator filed suit for patent infringement against generic player Impax in the United States District Court for the District of Delaware.
Earlier, in July, 2009, Indian generic player Lupin was sued by innovator for filing ANDA with Para IV certification for this product
Innovator GALDERMA LABS got approval from USFDA to market this product on May 26, 2006.
Doxycycline 40 mg DR capsules (Oracea) is indicated for the treatment of inflammatory lesions (papules and pustules) of rosacea in adult patients. According to Wolters Kluwer Health, U.S. sales of Doxycycline 40 mg DR capsules (Oracea) were approximately $104 million for the twelve-month period ending July 2009.
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