Teva Announces the U.S. Launch of the First Generic Version of THIOLA (tiopronin) tablets

Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced its launch of the first available generic version, in the U.S., of THIOLA (tiopronin) tablets, indicated, in combination with high fluid intake, alkali, and diet modification, for the prevention of cystine (kidney) stone formation in adults and pediatric patients 9 years of age and older with severe homozygous cystinuria, who are not responsive to these measures alone.

“Teva is pleased to provide patients with first-to-market access to a generic version of THIOLA (tiopronin) tablets for the prevention of kidney stones, and who are unresponsive to treatment with high fluid intake, alkali, and diet modification,” said Christine Baeder, SVP, Chief Operating Officer US Generics, Teva USA.

With nearly 550 generic medicines available, Teva has the largest portfolio of FDA-approved generic products on the market and holds the leading position in first-to-file opportunities, with approximately 100 pending first-to-files in the U.S. Currently, 1 in 11 generic prescriptions dispensed in the U.S. is filled with a Teva generic product.

About Tiopronin Tablets

Tiopronin tablets is a prescription medicine used in combination with high fluid intake, alkali (low acid), and dietary changes to help prevent the formation of one type (cystine) of kidney stone in certain adult and pediatric patients 9 years of age or older who do not respond to these measures alone.

IMPORTANT SAFETY INFORMATION

Who should not take tiopronin tablets?
Tiopronin tablets should not be taken if you are allergic to tiopronin or any of the ingredients in tiopronin tablets.

What should I tell my doctor before taking tiopronin tablets?
Before taking tiopronin tablets, tell your doctor about:

• all healthcare conditions you may have and any medications you take including prescription and over-the-counter medicines, vitamins, and herbal supplements.
• if you are pregnant or plan to become pregnant.
• if you are breastfeeding or plan to breastfeed.

What are the possible side effects of tiopronin tablets?
Tiopronin tablets can cause proteinuria (high amounts of protein in urine), including serious kidney problems, and hypersensitivity reactions (including fever, rash, joint pain and enlarged or swollen lymph nodes).

The most common side effects of tiopronin tablets include nausea, diarrhea or soft stools, sores in the mouth, rash, fatigue, fever, muscle or joint pain, high amounts of protein in urine, and vomiting.