Takeda Completes Settlements With All Defendants in U.S. Patent Litigation Involving Actos (pioglitazone HCI), ACTOplus met (pioglitazone HCl and metformin HCl) and duetact(R) (pioglitazone HCl and glimepiride)

DEERFIELD, Ill. and OSAKA, Japan, Dec. 21, 2010 /PRNewswire/ -- Takeda Pharmaceutical Company Limited ("Takeda") today announced that Takeda and its wholly-owned subsidiary, Takeda Pharmaceuticals North America, Inc. ("TPNA"), have completed settlements with all defendants in patent litigation brought against the companies in response to their Abbreviated New Drug Applications ("ANDAs") for generic ACTOS® (pioglitazone HCl), ACTOplus met® (pioglitazone HCl and metformin HCl), and duetact® (pioglitazone HCl and glimepiride). Takeda filed the lawsuits to enforce several patents that expire in 2016 relating to ACTOS, ACTOplus met, and duetact.

Agreements have been reached with the following generic companies and their respective affiliates: Mylan, Inc. ("Mylan"), Alphapharm Pty. Ltd. ("Alphapharm"), Watson Pharmaceuticals, Inc. ("Watson"), Ranbaxy Laboratories Limited ("Ranbaxy"), Sandoz, Inc. ("Sandoz"), Teva Pharmaceutical Industries, Ltd. ("Teva"), Torrent Pharmaceuticals Limited ("Torrent"), Dr. Reddy's Laboratories, Limited ("Dr. Reddy"), Wockhardt Limited ("Wockhardt"), Synthon Pharmaceuticals, Inc. ("Synthon") and Breckenridge Pharmaceutical, Inc. ("Breckenridge") (collectively, "the Synthon defendants"), and Aurobindo Pharma Limited ("Aurobindo").

Based on these settlements, Takeda continues to operate in accordance with its Mid-Range Plan, announced in May 2010, which assumes that market entry of generic ACTOS will occur on August 17, 2012, and that market entry of generic ACTOplus met and generic duetact will occur on December 14, 2012. With these settlements, the forecasts of Takeda's consolidated results for the full year of fiscal 2010 announced on October 29, 2010 will not be changed.

Takeda is the inventor and developer of ACTOS, which was launched commercially in the United States (U.S.) in 1999 for the treatment of type 2 diabetes and has been prescribed for more than 10 million patients to date.

Summary of Settlements

Takeda has granted Mylan, Watson, and Ranbaxy licenses to enter the U.S. market with generic ACTOS on August 17, 2012, subject to regulatory approval, or earlier under certain circumstances.

Mylan, Watson, and Ranbaxy are first-filers of ANDAs with paragraph IV certifications for ACTOS, and it is anticipated that the U.S. Food and Drug Administration will grant these companies 180-day marketing exclusivity. Takeda has granted Alphapharm, Sandoz, Aurobindo, Dr. Reddy, Wockhardt, the Synthon defendants, Teva, and Torrent licenses to enter the U.S. market with generic ACTOS beginning 180 days after the first-filers, subject to regulatory approval. Takeda has granted Teva a license to market an authorized generic version of ACTOS in the U.S. beginning on August 17, 2012, or earlier under certain circumstances.

Takeda also has granted Mylan a license to market generic ACTOplus met in the U.S. on December 14, 2012, or earlier under certain circumstances, subject to regulatory approval. As a first-filer of a patent certification for this product, it is anticipated that Mylan will receive 180 days of marketing exclusivity. Sandoz, Ranbaxy, Torrent, Watson, Aurobindo, Wockhardt, and Teva have been granted licenses to enter the U.S. market with generic ACTOplus met beginning 180 days after the first-filer, or earlier under certain circumstances, subject to regulatory approval. Takeda has granted Teva a license to market an authorized generic version of ACTOplus met in the U.S. beginning on December 14, 2012, or earlier under certain circumstances.

Lastly, Takeda has granted Sandoz a license to enter the U.S. market with generic duetact on December 14, 2012, or earlier under certain circumstances.

About ACTOS® (pioglitazone HCl) Family of Products Indications and Usage

ACTOS® (pioglitazone HCl), ACTOplus met® (pioglitazone HCl and metformin HCl), ACTOplus met® XR (pioglitazone HCl and extended-release metformin HCl), and duetact® (pioglitazone HCl and glimepiride) are prescription medications used with diet and exercise to improve blood sugar (glucose) control in adults (greater than or equal to 18 years of age) with type 2 diabetes.

Important Safety Information

Warnings

ACTOS, ACTOplus met, ACTOplus met XR, and duetact are not for everyone. Certain patients with heart failure should not start taking ACTOS, ACTOplus met, ACTOplus met XR, or duetact. These medications can cause new, or worsen, heart failure. Patients should talk to their doctor immediately if they experience unusually fast weight gain, fluid retention (swelling), shortness of breath, unusual tiredness, or slow heartbeat.

Warnings Specific to ACTOplus met and ACTOplus met XR

Metformin, one of the medicines in ACTOplus met and ACTOplus met XR, can cause a rare but serious condition called lactic acidosis (a buildup of an acid in the blood) that can cause death. Lactic acidosis is a medical emergency and must be treated in the hospital. Because lactic acidosis occurs most frequently in people with kidney problems, ACTOplus met and ACTOplus met XR should not be used in people with kidney disease or in people 80 years of age or older whose kidneys do not work properly.

ACTOplus met and ACTOplus met XR should not be taken by people with metabolic acidosis or who drink excessive amounts of alcohol.

Patients should talk to their doctor if they are going to have an X-ray procedure using injectable dye and are taking ACTOplus met or ACTOplus met XR.

ACTOS, ACTOplus met, ACTOplus met XR, and duetact are not for patients with type 1 "juvenile" diabetes or diabetic ketoacidosis.

Warning Specific to duetact: The chance of death from serious heart or blood vessel problems may be higher when using a sulfonylurea, an ingredient in duetact.

Precautions

ACTOS may cause low blood sugar when taken in combination with insulin or sulfonylureas. Lightheadedness, shakiness, dizziness, or hunger may mean that a patient's blood sugar is too low. Patients should talk to their doctor if low blood sugar is a problem for them.

Some people taking ACTOS, ACTOplus met, ACTOplus met XR, or duetact may experience mild-to-moderate swelling of legs and ankles, anemia, and weight gain.

If a patient is of childbearing age, they should talk to their doctor before taking ACTOS, ACTOplus met, ACTOplus met XR, or duetact, as this could increase their chance of becoming pregnant. Patients should talk to their doctor if they are pregnant, planning to become pregnant, breastfeeding, or planning to breastfeed.

Patients should not take ACTOS, ACTOplus met, ACTOplus met XR, or duetact if they have active liver disease. A doctor should perform a blood test to check for liver problems before a patient starts therapy and periodically thereafter. Patients should talk to their doctor immediately if they experience nausea, vomiting, stomach pain, unusual tiredness, loss of appetite, dark urine, or yellowing of the skin or eyes.

Some patients have experienced visual changes while taking ACTOS, ACTOplus met, ACTOplus met XR, or duetact. If a patient experiences vision problems, they should consult their doctor immediately.

Some people, particularly women, are at higher risk of having bone fractures while taking ACTOS, ACTOplus met, ACTOplus met XR, or duetact.

Precaution Specific to duetact: Taking glimepiride along with having an inherited condition where a patient doesn't produce enough of the enzyme G6PD (G6PD deficiency) can cause hemolytic anemia, which causes red blood cells to be destroyed too quickly.

Other side effects of these products may include:

ACTOS: cold or flu-like symptoms, headache, sinus infection, muscle pain, tooth disorder, and sore throat
ACTOplus met and ACTOplus met XR: cold or flu-like symptoms, diarrhea, nausea, headache, urinary tract infection, dizziness, and sinus infection
Duetact: cold or flu-like symptoms, headache, urinary tract infection, diarrhea, nausea, and limb pain


Patients are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

For ACTOS Complete Prescribing Information, including warning about heart failure, and Medication Guide, please click here.

For ACTOplus met and ACTOplus met XR Complete Prescribing Information, including warnings about heart failure, and lactic acidosis, and Medication Guide, please click here.

For duetact Complete Prescribing Information, including warning about heart failure, and Medication Guide, please click here.

Takeda Pharmaceuticals North America, Inc. and Takeda Global Research & Development Center, Inc.

Based in Deerfield, Ill., Takeda Pharmaceuticals North America, Inc. and Takeda Global Research & Development Center, Inc. are subsidiaries of Takeda Pharmaceutical Company Limited, the largest pharmaceutical company in Japan. The respective companies currently market oral diabetes, insomnia, rheumatology and gastroenterology treatments and seek to bring innovative products to patients through a pipeline that includes compounds in development for diabetes, cardiovascular disease, gastroenterology, neurology and other conditions. To learn more about these Takeda companies, visit www.tpna.com.

Takeda Pharmaceutical Company, Ltd.

Located in Osaka, Japan, Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to strive towards better health for patients worldwide through leading innovation in medicine. Additional information about Takeda is available through its corporate website, www.takeda.com.


SOURCE Takeda Pharmaceuticals North America, Inc.

 

Posted: December 2010


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