- Forteo® (teriparatide injection) is indicated to treat osteoporosis among certain women and men.
- This approval showcases Teva’s proven strengths in complex generic formulations development and device engineering.
- The approval and subsequent launch will enhance access to a critical treatment option for patients while serving to demonstrate Teva’s strategic goal of sustaining a generic powerhouse.
Teva Pharmaceuticals Inc., a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), announced today the approval of a generic version of Forteo®1, in the United States. Market availability of the product in the U.S. is expected in the coming weeks.
Teriparatide injection is indicated to treat osteoporosis among certain women and men. Please see the below “What is?” section for more information.
“We are thrilled to receive the long-awaited generic approval of this important drug-device combination product,” said Dr. Eric Hughes, Executive Vice President Global R&D and Chief Medical Officer. “This approval showcases Teva’s exceptional strengths in complex generic formulations development and device engineering, which support our ambitions to focus our generics pipeline on medicines that deliver the highest impact to patients. The approval will enhance access to a critical treatment option for patients while serving to demonstrate our strategic goal of sustaining a generic powerhouse.”
With nearly 500 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 12 generic prescriptions dispensed in the U.S. is filled with a Teva generic product.
Forteo® had annual sales of $609 million as of July 2023, according to IQVIA data.
Teva’s generic equivalent of Forteo® (teriparatide injection) utilizes the Antares Pharma, Inc. multi-dose pen device. Antares, a wholly owned subsidiary of Halozyme Therapeutics, Inc., and Teva are parties to an exclusive license, development and supply agreement for Teriparatide auto injector product that Teva markets in the EU and will market in the U.S.
What is teriparatide injection?
Teriparatide injection is a prescription medicine used to:
- treat postmenopausal women who have osteoporosis who are at high risk for having broken bones (fractures) or who cannot use other osteoporosis treatments. Teriparatide injection can lessen the chance of broken bones (fractures) in the spine and other bones in postmenopausal women with osteoporosis.
- increase the bone mass in men with primary or hypogonadal osteoporosis who are at high risk for having broken bones (fractures) or who cannot use other osteoporosis treatments.
- treat both men and women with osteoporosis due to use of glucocorticoid medicines, such as prednisone, for several months, who are at high risk for having broken bones (fractures) or who cannot use other osteoporosis treatments.
It is not known if Teriparatide injection is safe and effective in children.
Teriparatide injection should not be used in children and young adults whose bones are still growing.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about teriparatide injection?
Possible bone cancer. During drug testing, the medicine in Teriparatide injection caused some rats to develop a bone cancer called osteosarcoma. Studies in people have not shown that Teriparatide injection increases your chance of getting osteosarcoma. There is little information about the chance of getting osteosarcoma in patients using Teriparatide injection beyond 2 years.
Who should not use Teriparatide injection?
Do not use Teriparatide injection if you:
- are allergic to any of the ingredients in teriparatide injection. See the end of the Medication Guide for a complete list of the ingredients in Teriparatide injection.
Symptoms of a serious allergic reaction of Teriparatide injection may include swelling of the face, lips, tongue or throat that may cause difficulty in breathing or swallowing. Call your healthcare provider right away or get emergency medical help if you get any of these symptoms.
What should I tell my healthcare provider before using teriparatide injection?
Before you use Teriparatide injection, tell your healthcare provider about all of your medical conditions, including if you:
- have a certain bone disease called Paget’s disease or other bone disease.
- have bone cancer or have had a history of bone cancer.
- are a young adult whose bones are still growing.
- have had radiation therapy.
- are affected with a condition that runs in your family that can increase your chance of getting cancer in your bones.
- have or have had too much calcium in your blood (hypercalcemia).
- have or have had a skin condition with painful sores or wounds caused by too much calcium.
- have or have had kidney stones.
- take medicines that contain digoxin.
- are pregnant or plan to become pregnant. It is not known if Teriparatide injection will harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known if Teriparatide passes into your breastmilk. You should not breastfeed while taking Teriparatide injection.
Tell your healthcare provider about all the medicines you take including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
What are the possible side effects of Teriparatide injection?
Teriparatide injection may cause serious side effects including:
- See “What is the most important information I should know about Teriparatide injection?”
- Bone cancer (osteosarcoma): Tell your healthcare provider right away if you have pain in your bones, pain in any areas of your body that does not go away, or any new or unusual lumps or swelling under your skin that is tender to touch.
- Increased calcium in your blood. Tell your healthcare provider if you have nausea, vomiting, constipation, low energy, or muscle weakness. These may be signs there is too much calcium in your blood.
- Worsening of your kidney stones. If you have or have had kidney stones your healthcare provider may check the calcium levels in your urine while you use Teriparatide injection to see if there is worsening of this condition.
- Decrease in blood pressure when you change positions. Some people may feel dizzy, get a fast heartbeat, or feel light-headed right after the first few doses of Teriparatide injection. This usually happens within 4 hours of taking Teriparatide injection and goes away within a few hours. For the first few doses, give your injections of Teriparatide injection in a place where you can sit or lie down right away if you get these symptoms. If your symptoms get worse or do not go away, contact your healthcare provider before you continue using Teriparatide injection.
The most common side effects of Teriparatide injection include pain, nausea, and joint aches.
These are not all the possible side effects of Teriparatide injection. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please read the Medication Guide in the full Prescribing Information.
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) has been developing and producing medicines to improve people’s lives for more than a century. We are a global leader in generic and innovative medicines with a portfolio consisting of over 3,500 products in nearly every therapeutic area. Around 200 million people around the world take a Teva medicine every day, and are served by one of the largest and most complex supply chains in the pharmaceutical industry. Along with our established presence in generics, we have significant innovative research and operations supporting our growing portfolio of innovative and biopharmaceutical products. Learn more at www.tevapharm.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. You can identify these forward-looking statements by the use of words such as “should,” “expect,” “anticipate,” “estimate,” “target,” “may,” “project,” “guidance,” “intend,” “plan,” “believe” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. Important factors that could cause or contribute to such differences include risks relating to: the development, launch and commercial success of our generic version to Forteo® (Teriparatide injection); our ability to successfully compete in the marketplace, including that we are substantially dependent on our generic products, concentration of our customer base and commercial alliances among our customers, delays in launches of new generic products and the increase in the number of competitors targeting generic opportunities and seeking U.S. market exclusivity for generic versions of significant products; our ability to successfully launch and execute our new Pivot to Growth strategy, including to expand our innovative and biosimilar medicines pipeline and profitably commercialize the innovative medicines and biosimilar portfolio, whether organically or through business development and to sustain and focus our portfolio of generics medicines; our substantial indebtedness; our business and operations in general, including, the impact of global economic conditions and other macroeconomic developments and the governmental and societal responses thereto, and costs and delays resulting from the extensive pharmaceutical regulation to which we are subject; compliance, regulatory and litigation matters, including failure to comply with complex legal and regulatory environments; other financial and economic risks; and other factors discussed in our Quarterly Report on Form 10-Q for the third quarter of 2023 and in our Annual Report on Form 10-K for the year ended December 31, 2022, including in the section captioned “Risk Factors.” Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.
1 Forteo® is a registered trademark of Eli Lilly Pharmaceuticals.
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