Andrx pharmaceuticals concerta
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The district court construed the claim to include nonosmotic as well as osmotic dosage forms, as ALZA requested. The asserted claims were held nonobvious but not infringed and invalid for lack of enablement because the specification does not enable the full scope of claim 1.
On appeal, andrx pharmaceuticals concerta, ALZA argued that the district court erred in finding claim 1 invalid for lack of enablement.
The parties agreed that the claim construction adopted by the district court required the enablement of both osmotic and nonosmotic dosage forms, and that osmotic dosage forms were enabled.
The dispute was whether the specification would have enabled a person of ordinary skill in the art concerta create nonosmotic oral dosage forms e. However, when methylphenidate is delivered at a steady state over a sustained period of time, acute pharmaceutical often develops. The undesirable clinical effects of steady state sustained release formulations are overcome by multiple dosing whereby the intensity of the therapeutic effects of the methylphenidate can be maintained, andrx pharmaceuticals concerta.
The sustained release tablet form of methylphenidate hydrochloride described in U. This does not model the multiple dose administration of immediate release methylphenidate hydrochloride andrx.
Controlled release of the medication is achieved by a hydrogel matrix. The sustained release formulation of methylphenidate described in U.
One group provides a substantially immediate pharmaceutical of methylphenidate drug, the other supplies a dose of methylphenidate delayed by about 2 to 7 hours. Sustained release andrx of methylphenidate have been developed, andrx pharmaceuticals concerta, which provide for the slow release of the drug over the course of the day. However it has been observed that peak plasma concentrations of the drug are lower when sustained release formulations are used.
Studies have shown that sustained pharmaceutical formulations of concerta have been shown to have lower efficacy than conventional dosage forms, andrx pharmaceuticals concerta. Although the prior concerta controlled release formulation provide steady increases in the blood level of methylphenidate hydrochloride, they may be less than desirable because their delivery andrx do not mimic the plasma profile of multiple dose regimens known to prevent tolerance.
To overcome the concerta mentioned problems with sustained delivery of methylphenidate, the present invention provides the needed delivery system whereby the drug can be administered in a single dose and provide the andrx delivery rate so that tolerance to its effects will not develop. Furthermore, a pharmaceutical effective daily dose will eliminate the risk of theft or loss of the second dose and increase the medications overall therapeutic value.
The active ingredient is delivered such that plasma peaks and troughs experienced in multiple dosing are present. Thus, andrx pharmaceuticals concerta, the invention provides a single dose delivery system that attains the desired therapeutic multiple dosing regimen plasma levels. One embodiment of the present invention provides a unitary controlled release solid dosage form for the oral administration of a central nervous system stimulant such as methylphenidate hydrochloride, andrx pharmaceuticals concerta.
The pharmaceutical formulation contains a drug core or tablet, a controlled release coating surrounding the core or tablet, an immediate release layer applied to the controlled release coating and an optionally aesthetic overcoat covering.
The core tablet is a mixture of the active pharmaceutical compound, a diluent, a binding agent and optionally other conventional processing aids such as anti-sticking agents, fillers and glidants.
The controlled release coating surrounds the core tablet and is comprised of an enteric polymer and optionally other conventional processing aids such as surfactants, plasticizers and anti-sticking agents. The immediate release drug layer is applied over the controlled release coating and is a mixture of active ingredient, a binder, and an optionally a stabilizer. Andrx has been placed on "official action indicated" status, meaning the deficiencies were severe enough for the FDA to halt the new approvals and possibly issue fines, order recalls and seize products, andrx pharmaceuticals concerta.
FDA inspectors returned to the plant on March 6, and are expected to take as long as four weeks to review Andrx's corrective actions and several more weeks to present their findings to agency officials in Maryland. Should they take further action concerta Andrx, the deal with Watson could be terminated, according to the merger agreement.
Watson's chief executive officer, Dr, andrx pharmaceuticals concerta. Allen Chao, expressed confidence during an pharmaceutical conference call with analysts andrx there would be a positive outcome. He said Watson officials reviewed the issues with Andrx's leaders and felt confident they had made a strong effort to correct the deficiencies.
The FDA's Center for Andrx might discuss any remaining concerns with manufacturing procedures with the new pharmaceuticals, who could then be subject to a warning letter should problems remain, an FDA official said.
With him on the brief were David T, andrx pharmaceuticals concerta. concerta
Wagner and Peter S. Choi, of Washington, DC. With him on the brief were John W.
Bateman and Robert F. Following a bench trial, the district court found the patented treatment methods of U. We affirm because we conclude that the asserted claims of the ' patent are invalid for lack of enablement.
The ' patent application, filed inclaimed concerta to provisional application No. This formulation releases the drug within minutes and treats andrx symptoms for three to five hours, andrx pharmaceuticals concerta. As a result, such prior drug treatments were taken two or three times a day.
As pharmaceuticals patients who take ADHD medication are children, they took one dose before school and one or two additional doses about four to five hours apart, at least one of which was administered at school. At the time of the invention, it was well known how to develop sustained-release dosage forms, also known as "controlled release" or "extended release. It was also known that sustained-release dosage forms could exhibit descending or ascending release rates by manipulating the methods and materials used to produce the dosage forms.
Using this knowledge, andrx pharmaceuticals concerta, ALZA developed safe and effective once-a-day extended release oral dosage forms that could deliver MPH with the ascending release lioresal achat en ligne. Admittedly, andrx pharmaceuticals concerta, the bulk of ALZA's efforts went into developing concerta osmotic dosage form, which uses andrx compartment containing drug and various osmotic excipients.
ALZA subsequently filed its patent applications, andrx pharmaceuticals concerta. Claim 1, andrx pharmaceuticals concerta, the only independent claim implicated on appeal, of the ' patent claims: A method for andrx ADD or ADHD comprising administering a pharmaceutical form comprising methylphenidate that provides a release of methylphenidate at an ascending release rate over an extended period of time. The specification focuses on how osmotic systems can be adapted to create concerta ascending pharmaceutical pharmaceutical form to treat ADHD.
The specification also mentions non-osmotic dosage forms. The district court held a Markman hearing on the construction of various concerta in dispute. In andrx Andrx's attempt to limit the scope of the claim to osmotic dosage forms, the court construed the phrases "pharmaceutically acceptable composition" and "dosage form" to mean "a pharmaceutical composition that includes a dose of methylphenidate," which includes non-osmotic dosage forms, as ALZA requested.
District Court decision received in Concerta patent sase
Further, andrx pharmaceuticals concerta, the pharmaceutical construed the disputed term "an ascending release rate over an extended period concerta time" to mean: The release rate is determined by andrx appropriate in-vitro dissolution test. The ascending release rate does not include release of drug from any immediate-release drug coating that may be applied to the dosage form.
Following a bench trial, the district court determined that the ' patent was not infringed, andrx pharmaceuticals concerta. The district court concluded that claim 1, as construed, "require[s] release of non-IR MPH during the initial interval of an appropriate dissolution test.
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