Patent 11123331

Prior art

Earlier patents, publications, and products that may anticipate or render the claims unpatentable.

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Prior art

Earlier patents, publications, and products that may anticipate or render the claims unpatentable.

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Most Relevant Prior Art for US Patent 11,123,331

As of May 30, 2026, a review of US Patent 11,123,331 ("Tacrolimus for improved treatment of transplant patients") identifies several key prior art documents explicitly referenced within the patent text. These references provide the technical background and context against which the invention is set. The priority date for US Patent 11,123,331 is May 30, 2007.

Due to the unavailability of the full text of the claims for US Patent 11,123,331 in the provided information, a definitive analysis of which specific claims each prior art document potentially anticipates under 35 U.S.C. § 102 cannot be made. However, based on the description of US11123331 and the context in which these patents are cited, their general relevance to the claimed invention can be inferred. The independent claims of US11123331 are generally understood to relate to an extended-release oral dosage form of tacrolimus with specific dissolution and pharmacokinetic properties, and a method of once-daily immunosuppressive treatment using this dosage form.

The most relevant prior art explicitly cited in US11123331 includes:

  • EP-A-0 184 162

    • Full Citation: EP0184162A1 (or EP-A-0 184 162)
    • Publication/Filing Date: Published 1986-06-25 (Priority date not explicitly stated in US11123331 but earlier than publication).
    • Brief Description: This European patent describes the preparation of tacrolimus itself.
    • Potential Anticipation (35 U.S.C. § 102): This reference describes the active pharmaceutical ingredient (tacrolimus). If any claims in US11123331 were broadly directed to tacrolimus per se, this patent could potentially anticipate them. However, given the focus of US11123331 on extended-release formulations and methods of treatment, this reference primarily serves to establish the known nature of the active compound.

  • EP-A-0 444 659

    • Full Citation: EP0444659A1 (or EP-A-0 444 659)
    • Publication/Filing Date: Published 1991-09-04 (Priority date not explicitly stated in US11123331 but earlier than publication).
    • Brief Description: This European patent discloses various analogues of tacrolimus.
    • Potential Anticipation (35 U.S.C. § 102): Similar to EP-A-0 184 162, this reference would be relevant to claims broadly encompassing tacrolimus analogues. Its primary role is to define the scope of related active substances that could be used in formulations, rather than anticipating the specific extended-release features of US11123331.

  • U.S. Pat. No. 6,387,918

    • Full Citation: US6387918B1
    • Publication/Filing Date: Published 2002-05-14 (Priority date not explicitly stated in US11123331 but earlier than publication).
    • Brief Description: This U.S. patent also discloses analogues of tacrolimus.
    • Potential Anticipation (35 U.S.C. § 102): As with EP-A-0 444 659, this patent broadens the definition of the active compounds. It would be anticipatory only if US11123331 contained very broad claims to tacrolimus analogues without the specific extended-release or pharmacokinetic characteristics.

  • WO 1999/049863 (cited as WO99/49863)

    • Full Citation: WO1999049863A1
    • Publication/Filing Date: Published 1999-10-07 (Priority date 1998-03-31).
    • Brief Description: This PCT application describes the conventional, fast-release Prograf® product, including its composition with HPMC, lactose, and croscarmellose sodium. It is noted as developed by Fujisawa Pharmaceutical Co..
    • Potential Anticipation (35 U.S.C. § 102): This document defines the baseline "immediate release" tacrolimus product against which the improvements of US11123331 are measured. It would not anticipate the extended-release features, lower Cmax, or improved pharmacokinetic profile claimed by US11123331, but rather establish the state of the art for immediate-release tacrolimus.

  • WO 2000/050007

    • Full Citation: WO2000050007A1
    • Publication/Filing Date: Published 2000-08-31 (Priority date 1999-02-19).
    • Brief Description: This PCT application discloses amphiphilic surfactants as suitable excipients for pharmaceutical compositions, particularly those comprising hydrophobic drugs.
    • Potential Anticipation (35 U.S.C. § 102): If US11123331 claims the use of specific amphiphilic surfactants as excipients, this document could potentially anticipate those claims, especially if the claimed surfactants or their function within the formulation are not uniquely tied to the extended-release properties of the present invention.

  • WO 2003/004001

    • Full Citation: WO2003004001A1
    • Publication/Filing Date: Published 2003-01-16 (Priority date 2001-07-06).
    • Brief Description: This PCT application describes a controlled agglomeration method for preparing particulate material, which is stated to be a "particularly useful method" for the present invention and provides suitable carriers.
    • Potential Anticipation (35 U.S.C. § 102): This patent could potentially anticipate claims in US11123331 related to specific manufacturing processes (e.g., controlled agglomeration) or the use of carriers prepared by such methods, especially if the claims do not include further distinguishing features critical to the extended release of tacrolimus.

  • WO 2005/020993 (also known as WO05020993A1)

    • Full Citation: WO2005020993A1
    • Publication/Filing Date: Published 2005-03-10 (Priority date 2003-08-29).
    • Brief Description: This PCT application, by the same inventors as US11123331, describes different tacrolimus formulations that showed improved bioavailability compared to Prograf® in animal studies. It suggests improved bioavailability is linked to tacrolimus being in a dissolved state.
    • Potential Anticipation (35 U.S.C. § 102): This reference is highly relevant as it comes from the same inventors and discusses improved bioavailability of tacrolimus formulations. It could potentially anticipate claims relating to improved bioavailability of tacrolimus formulations, especially those involving the drug in a dissolved state, unless the claims of US11123331 are sufficiently distinct in their specific extended-release profile, pharmacokinetic parameters, or other structural/compositional features.

  • WO 2005/020994 (also known as WO05020994A1)

    • Full Citation: WO2005020994A1
    • Publication/Filing Date: Published 2005-03-10 (Priority date 2003-08-29).
    • Brief Description: This PCT application, also by the same inventors, specifically relates to solid dispersions comprising tacrolimus.
    • Potential Anticipation (35 U.S.C. § 102): Similar to WO 2005/020993, this document is very close prior art by the same inventors. It could anticipate claims in US11123331 directed to tacrolimus in solid dispersion form, particularly if the claims do not specify unique compositional elements or the precise extended-release characteristics that differentiate the current invention.

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