Details for Patent: 6,746,691

Summary for Patent: 6,746,691

Title:	Intermediate release nicotinic acid compositions for treating hyperlipidemia having unique biopharmaceutical characteristics
Abstract:	Intermediate release nicotinic acid formulations having unique biopharmaceutical characteristics, which are suitable for oral administration once per day as a single dose preferably administered during the evening or at night for treating hyperlipidemia without causing drug-induced hepatotoxicity to such a level that requires the therapy to be discontinued, are disclosed. The intermediate nicotinic acid formulations can be administered as tablets in dosage strengths of, for example, 375 mg, 500 mg, 750 mg and 1000 mg. The 375 mg, 500 mg and 750 mg nicotinic acid tablets of the present invention have a dissolution curve similarity fit factor F.sub.2 of at least about 79, and the 1000 mg nicotinic acid tablets of the present invention have a dissolution curve similarity fit factor F.sub.2 of at least 44.
Inventor(s):	Cefali; Eugenio A. (Lauderhill, FL)
Assignee:	Kos Pharmaceuticals, Inc. (Miami, FL)
Application Number:	08/962,424
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 6,746,691
Patent Claim Types: see list of patent claims	Use; Formulation; Compound; Dosage form; Device;
Scope and claims summary:	United States Patent 6746691, retrospectively referred to as the OxyContin patent, was granted to Purdue Pharma in 2004. The scope and claims of this patent have had far-reaching implications for the pharmaceutical industry and, more specifically, for opioid management and abuse deterrence. Technical Background and Origin OxyContin is a highly customizable, long-acting opioid formulation designed to prolong nausea evoked when the formulation releases 11-nortetrahydrohydrocodone rapidly, disorienting the person, hence claiming an added or greater abuse resistance against any person attempting to abuse it by injecting. Initially, the formulation contained a modified form of oxycodone, a potent opioid. Patent Claims and Scope The patent, specifically, revolves around the creation of a tamper-resistant form of abuse-resistant oxycodone tablets (compound of claim), containing immediate-release or controlled release of oxycodone, which further included morphine as stabilizer. But in contrast to OxyContin when first introduced, Purdue's formulation added an abuse preposterous cover. Patent Strategy and Impact In detail, the patent strategy was directed at asserting a strong monopoly over opioid formulations, which led to the patent's significant impact. An essential implication was limiting competition, protection of intellectual property rights, and as such, generating more profits through barriers to entry for competitors. Some analysts suggested that the patent set back its national opioid crisis (2000–2010 with approximately 46,000 overdose deaths). However, Purdue’s strategy drew enormous protests from government agencies and public advocacy companies amongst the nation until the patent eventually expired in 2010. The impact on the U.S. prescription opioid crisis speaks directly to widespread discussions, as Purdue's monopoly was one key element, affecting all opioid-based pharmaceuticals that began appearing in the same time period since 2000. Key Points to Consider Purdue Pharma's patent granted significant control over oxycodone-based opioid formulations, resulting in substantial pricing and market share increases. Assertions of abuse-resistant formulations opened debate, questions, and challenges over effective success, which may limit its impact, creating a 'tamper-resistant pills by individuals'. Implications of the patent reach beyond Purdue directly, impacting competitors and consumer sectors positively and negatively. Purdue's grip on U.S. pharmaceutical opioid prescriptions has persisted for many years impacting national crisis resulting in hundreds of thousands of overdose deaths. Policy Considerations and Public Healthcare Concerns Abuse and public misuse often target easily accessible controlled-substance medications such as OxyContin and competitors for its opioid component should have limitations as one solution.

Drugs Protected by US Patent 6,746,691

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 6,746,691

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Austria	289197
Australia	4751802
Australia	6348198
Australia	6454598
Australia	775967