2014

Ferring Pharmaceuticals Inc. Receives Positive Verdict in Patent Infringement Lawsuit for LYSTEDA® (tranexamic acid)

PARSIPPANY, N.J., Feb. 3, 2014 /PRNewswire-USNewswire/ -- Ferring Pharmaceuticals Inc. (Ferring) today announced that their patents for LYSTEDA® (tranexamic acid), a non-hormonal prescription medicine to treat heavy monthly menstrual bleeding, have been found valid and infringed by both Watson Pharmaceuticals Inc. (Watson) and Apotex Inc. (Apotex).

The separate lawsuits against Watson and Apotex were filed by Ferring in July 2011 and alleged that the Abbreviated New Drug Applications (ANDAs) filed by each for tranexamic acid tablets, the generic equivalent to LYSTEDA, infringe Ferring's patents for the product.  

The positive verdicts by the court confirm LYSTEDA's exclusivity.  Watson and Apotex can appeal the decisions and/or attempt to amend their respective ANDAs that exclude infringing products.

"Ferring has been 100 percent committed to protecting our intellectual property and we are pleased by the outcome," said Aaron Graff, President & COO, Ferring Pharmaceuticals Inc.  "LYSTEDA is backed by scientific data and we believe in its value to help women suffering from heavy monthly bleeding."

About LYSTEDA

LYSTEDA® (tranexamic acid) tablets is a prescription medicine used to treat your heavy monthly period (menstruation) when your bleeding gets in the way of social, leisure and physical activities. LYSTEDA does not contain any hormones and is taken only during your period. It does not treat premenstrual symptoms, does not affect your fertility, and cannot be used as birth control. It does not protect against sexually transmitted diseases. LYSTEDA has not been studied in adolescents younger than 18 years of age.

Important Safety Information

Do not take LYSTEDA if:

  • You currently are using a form of birth control that contains estrogen and a progestin (like birth control patch or vaginal ring).  Ask your healthcare provider before taking LYSTEDA if you are not sure if your birth control method contains estrogen or progestin;
  • You have or have ever had a blood clot, have been told you are at risk for having a blood clot; or
  • You are allergic to LYSTEDA or tranexamic acid.

LYSTEDA can cause serious side effects, including:

  • The risk of serious blood clots may be increased when LYSTEDA is taken with medicines used to help your blood clot or some medicines used to treat leukemia.
  • Stop taking LYSTEDA and promptly report any eye problems to your healthcare provider.
  • If you have shortness of breath and your throat feels tight, stop taking LYSTEDA and get medical help right away.

Before taking LYSTEDA, tell your healthcare provider about all of your medical conditions, including whether: you have ever had a blood clot or been told that you are at risk of having a blood clot, you are using a form of birth control that contains hormones, you are pregnant or think you may be pregnant, you are breastfeeding or plan to breast-feed, the time between the start of your periods is less than 21 days or more than 35 days, or you have any other medical conditions.

Tell your healthcare provider about all the medicines you take, especially if you take: birth control pills or other hormonal birth control, medicines used to help your blood clot, medicines used to break up blood clots, or any medicines to treat leukemia.

The most common side effects of LYSTEDA include: headaches, sinus and nasal problems, back pain, pain in your abdomen, pain in your muscles or joints, anemia, and fatigue.

If you notice a change in your usual bleeding pattern that worries you, or your heavy bleeding continues, contact your healthcare provider right away. This may be a sign of a more serious condition.

You are encouraged to report side effects of prescription drugs. Contact Ferring at 1-888-FERRING (1-888-337-7464) or call 1-800-FDA-1088 or visit www.fda.gov/medwatch.

About Ferring Pharmaceuticals Inc.

Ferring Pharmaceuticals Inc. is a subsidiary of Ferring Pharmaceuticals, a privately owned, international pharmaceutical company. Ferring Pharmaceuticals offers a line of products in the U.S. market.

Ferring Pharmaceuticals specializes in the research, development and commercialization of compounds in general and in the fields of Reproductive Health, Gynecology, Orthopaedics and Gastroenterology. For more information, call 1-888-FERRING (1-888-337-7464) or visit www.FerringUSA.com.

Please visit www.lysteda.com for Full Prescribing Information.

SOURCE Ferring Pharmaceuticals Inc.




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