Mission Pharmacal Settles Patent Infringement Suit With Virtus Pharmaceuticals

Federal court in Texas upholds Mission's dual-iron patent covering one of the nation's most prescribed prenatal vitamin brands.

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Mission Pharmacal Company

Oct 14, 2014, 02:48 ET

SAN ANTONIO, Oct. 14, 2014 /PRNewswire/ -- Mission Pharmacal Company, headquartered in San Antonio, today announced that the U.S. District Court for the Western District of Texas has issued a consent judgment confirming the validity of its dual-iron patent (U.S. Pat. No. 6,521,247) at the conclusion of the lawsuit filed against Virtus Pharmaceuticals, LLC.

"Mission Pharmacal stands behind our patent covering our Ferr-Ease® dual-iron delivery system in our popular CitraNatal® family of prenatal vitamins," says Lee Cusenbary, General Counsel, Mission Pharmacal. "The consent judgment supports our continued belief in the validity of the '247 patent in all respects."

This consent judgment preserves the exclusive high-quality prenatal vitamin formulation used in the CitraNatal supplements relied on by pregnant women for many years. The patent protects CitraNatal's use of a specific combination of iron that combats iron deficiency anemia before, during, and after pregnancy.

"The patented dual-iron formulation used in Mission's CitraNatal supplements helps pregnant women get the iron they need, yet it is gentle on the gastrointestinal system," says Nancy Price, Senior Product Manager, CitraNatal, Mission Pharmacal. "We have designed the complete CitraNatal line of science-based, quality-focused supplements with a woman's nutritional support and convenience in mind."

Mission Pharmacal has successfully asserted its dual-iron patent before. In 2013, PureTek Corporation consented to a judgment that recognized the validity of the '247 patent and classified its generic prenatal vitamins as infringing. In 2010, two other sources of generic substitutes for patented CitraNatal supplements withdrew from the market once faced with a patent infringement lawsuit.

"We will continue to protect the '247 patent with equal vigor against any infringing products," says Cusenbary.

The patented formulation is incorporated in CitraNatal Harmony®, CitraNatal Assure®, CitraNatal® 90 DHA, CitraNatal® DHA, CitraNatal B-Calm®, and CitraNatal® basic™ as well as Mission's Ferralet® 90 prescription iron supplement. Mission Pharmacal retains exclusive use of the protected formulation featured in the CitraNatal and Ferralet 90 products until 2020. For more information about CitraNatal or Ferralet products, visit citranatal.com or ferralet.com.

INDICATIONS: CitraNatal Harmony^®, CitraNatal Assure^®, CitraNatal B-Calm^®* and CitraNatal^® 90 DHA are multivitamin/mineral prescription drugs indicated for use in improving the nutritional status of women prior to conception, throughout pregnancy, and in the postnatal period for both lactating and nonlactating mothers.
*CitraNatal B-Calm may be used in conjunction with a physician prescribed regimen to help minimize pregnancy related nausea and vomiting.

Important Safety Information

CONTRAINDICATIONS: These products are contraindicated in patients with a known hypersensitivity to any of the ingredients.

WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. KEEP THESE PRODUCTS OUT OF THE REACH OF CHILDREN. In case of accidental overdose, call a doctor or poison control center immediately.

WARNING: More than 3 grams total intake per day of omega-3 fatty acids from all sources, including both food and supplements (like Docosahexaenoic Acid [DHA] and Eicosapentaenoic Acid [EPA]), have been shown to have potential antithrombotic effects, including an increased bleeding time and INR. Administration of omega-3 fatty acids should be avoided in patients on anticoagulants and in those known to have an inherited or acquired bleeding diathesis.⁺

⁺CitraNatal B-Calm does not contain DHA or EPA.

WARNING: Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B₁₂ is deficient.

For more information about CitraNatal products, including full Prescribing Information and Precautions and Adverse Reactions, please visit citranatal.com.

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