The MannKind promise

From concept to commercialization, MannKind collaborates with pharmaceutical organizations of all sizes, working flexibly and seamlessly to create products and technologies that truly break the mold.

  • 250M

    CARTRIDGES/YR IN CAPACITY

  • >40

    MOLECULES FORMULATED

  • ISO 8

    PRODUCTION CLEAN ROOMS

  • 328K

    TOTAL SQUARE FEET

Bring your vision to market

As a fully licensed drug and medical device manufacturer, we have the space, equipment, quality control, and expertise to make technologies and therapies that can change lives for the better.

Our pipeline reflects how we, as well as our partners, are applying MannKind technology to develop and advance new products to not only help people take control of their health, but truly thrive.

explore our pipeline

MannKind and United Therapeutics entered into a worldwide exclusive licensing and collaboration agreement in September 2018 for the development of Tyvaso DPI®. As a next-generation formulation of treprostinil, Tyvaso DPI incorporates the dry-powder Technosphere technology and Dreamboat® inhalation device.

MannKind and Cipla Ltd., a global pharmaceutical company, entered into an exclusive supply and distribution agreement for the commercialization of Afrezza® (insulin human) Inhalation Powder in India. Under the terms of the agreement, Cipla will be responsible for obtaining regulatory approvals to distribute Afrezza® in India as well as all marketing and sales activities. MannKind will manufacture and supply Afrezza to Cipla.

MannKind and BIOMM SA entered into an exclusive supply and distribution agreement for the commercialization of Afrezza® (insulin human) Inhalation Powder in Brazil. MannKind manufactures and supplies Afrezza to Biomm, and Biomm is responsible for promoting and distributing Afrezza within Brazil.

MannKind and Thirona entered into an agreement to evaluate the therapeutic potential of Thirona’s locally acting TGF-β inhibitor, FBM5712, for the treatment of pulmonary fibrosis. MannKind is developing MNKD-501, a dry powder inhaled formulation of FBM5712. If initial studies are promising, MannKind can exercise certain rights to seek a full license to the compound for clinical development and commercialization for the treatment of fibrotic pulmonary diseases.

Our capabilities:

At our FDA-inspected and approved site, we develop advanced drug delivery systems that use our breakthrough technology.

Technosphere® Technology

technosphere

State-of-the-art development technologies optimize dry powder formulation with inhalation devices early in the development process to ensure successful drug delivery in first-in-human studies.

Technosphere technology has been shown to be compatible with a wide range of active pharmaceutical ingredients (API) properties:
  • Molecular weight of 200 to 150,000 daltons (Da)
  • Drug content up to 90% by weight
Through controlled crystallization, spray drying, lyophilization and performance-enhancing excipients, MannKind has developed a suite of superior processing techniques which form reproducible, well-controlled particles that are:
  • Perfectly sized for inhalation
  • Fixed in size prior to API introduction
  • Free from requiring sizing, milling or blending
Microparticles are formed from fumaryl diketopiperazine (FDKP), which is FDA-approved and an ideal excipient for inhalation drug delivery. FDKP is compatible with a wide range of APIs and reproducible with well-controlled particle formation. It is excreted unchanged in urine and has demonstrated excellent safety through an extensive complete technology package.

Inhalation innovation

Small, portable, and easy to use

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    Re-usable Dreamboat®
    (Gen 2) Family

    For chronic therapies

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    Single Use Cricket® Solutions

    For more acute therapies

The breath-powered inhalers from MannKind, which are available for collaboration projects or licensing, are simple, easy to use and discreet. They are disposable, and no cleaning is required. More importantly, they have excellent delivery efficiency.

  • Applicable to a broad range

    Applicable to a broad range

    of therapies and formulations

  • Wide achievable dose range

    Wide achievable dose range

    0.001 mg to 5 mg from a single cartridge

  • Proven to deliver

    Proven to deliver

    up to 70% of the dry-powder dose deep into the lungs

  • Flexible for use

    Flexible for use

    with small-, medium-, or large-dose cartridges

  • Manufactured readily

    Manufactured readily

    at a low cost

bluhale

BluHale® Inhalation Training Device

BluHale helps make our simple inhaler even easier to use. The BluHale connected care ecosystem includes:

  • BluHale PRO<sup>®</sup> edition

    BluHale PRO® edition

    For healthcare providers for in-office training on effective inhalation techniques

  • BluHale VIS<sup>®</sup> edition

    BluHale VIS® edition

    For consumers has additional sensors to detect device orientation plus dosage strength and timing

h-patchTM

The wearable h-Patch drug delivery platform, upon which the V-Go® once-daily wearable insulin delivery device is built, provides a continuous, preset, subcutaneous rate of medication for 1-72 hours via a needle that remains under the skin.

Designed to be patient friendly, the hydraulically engineered device:

  • Is discreet

    Worn like a patch

  • Is easy to use

    No complicated technology

  • Eliminates injections

    No medication by pens or syringes

h-pathc front h-patch back imgfront imgHover flip for back side
WEARABLE H-PATCH DRUG DELIVERY BEGINS WITH THE PUSH OF A BUTTON

Intellectual property protection is a priority

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    Technosphere technology

    >1,000 patents in place worldwide

    >1,000 utility and >200 design patents

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    The power of patents: Afrezza®

    >600 patents provide protection to Afrezza and related technologies.

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    h-patch:

    >150 patents and patent applications*

*INCLUDES WEARABLE H-PATCH DRUG DELIVERY, NEXT GEN DEVICES, METHODS OF USE AND ASSOCIATED TECHNOLOGIES.
SC=SUBCUTANEOUS.

Bring product to market rapidly and responsibly

The MannKind Fast Feasibility program is designed to rapidly obtain technical feasibility and animal proof of concept by:

  • Preparing Technosphere test powders with API

    Timeline: 1-3 months

    Deliverables: Assay, drug loading, particle aerodynamics, drug product stability

  • Evaluating delivery in animal models

    Timeline: 1-3 months

    Deliverables: PK, bioavailability

  • Data analysis

    Co-author final report

Two ways to connect

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Let’s continue the conversation

With our innovative Technosphere and h-Patch technologies, our team of dedicated scientists and medical professionals are developing therapeutic products for people with serious medical conditions to help give them control of their health and live life without limits.

We look forward to discussing potential collaboration opportunities by:

Filling out the form to the right -OR- email us at bd@mannkindcorp.com