about Tadalafil OD!FS®

MARKET ANALYSIS

of PDE-5 inhibitors
for Erectile Dysfunction
in 2014

(Worldwide, unit: million USD)

Tadalafil OD!FS®

microgranule

‣ Oral Dissolving in a Few Seconds (A new concept of formulation which dissolves in a few seconds without water)

‣ Patented for new formulation platform technology

✓ KOREA PATENT PUBLICATION 1340733 (NOVEL MICROGRANULE FORMULATION)
✓ KOREA PATENT PUBLICATION 1340733 (MICROGRANULE FORMULATION INCLUDING COHESION UNIT CONSISTING OF DISCONTINUOUS PHASE AND CONTINUOUS PHASE)

DISSOLVED AT THE FASTEST
SPEED IN THE WORLD!

Incrementally
modified drug of
new formulation

  • Tablet → OD!FS® microgranule
    (orally dissolving microgranule)
  • Verified equality

Dosage


  • 5 mg / sachet
  • 10 mg / sachet
  • 20 mg / sachet

Administration


  • Oral administration at bed time
    → OD!FS® is the first product that can be administered without water
  • Rapid onset

Features


  • Orally dissolving microgranule adminstered without water
  • The fastest orally dissolving formulation (within 3-5 seconds)
  • Diluting agent not affecting blood glucose level
  • Unnecessary to brush teeth after administration (no sugar is included)

Tadalafil OD!FS®

microgranule

Indication & Usage

TADALAFIL OD!FS® microgranule is a phosphodiesterase 5 (PDE-5) inhibitor indicated for the treatment of:

  • Erectile Dysfunction (ED)
  • The signs and symptoms of benign prostatic hyperplasia (BPH)
  • ED and the signs and symptoms of BPH (ED/BPH)

Dosage and Administration

TADALAFIL OD!FS® microgranule for use as needed:

  • Erectile Dysfunction
  • Starting dose: 10 mg as needed prior to sexual activity. Increase to 20 mg or decrease to 5 mg based upon efficacy/tolerability. Improves erectile function compared to placebo up to 36 hours post dose. Not to be taken more than once per day

TADALAFIL OD!FS® microgranule for once daily use:

  • Erectile Dysfunction
  • 2.5 mg taken once daily, without regard to timing of sexual activity. May increase to 5 mg based upon efficacy and tolerability.

  • Benign Prostate Hyperplasia
  • 5 mg, taken at approximately the same time every day

  • Erectile Dysfunction and Benign Prostate Hyperplasia
  • 5 mg, taken at approximately the same time every day

TADALAFIL OD!FS® microgranule may be taken without regard to food.

PK Profiles of Tadalafil