TEL AVIV, Israel & PARSIPPANY, N.J.--(BUSINESS WIRE )--Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), announced today the launch of a first generic version of Revlimid®1 (lenalidomide capsules), in 5mg, 10mg, 15mg, and 25mg strengths, in the United States.
Teva’s Lenalidomide capsules are a prescription medicine used in adults for the treatment of (1) multiple myeloma in combination with the medicine dexamethasone, (2) certain myelodysplastic syndromes, and (3) mantle cell lymphoma following specific prior treatment. Please see the below “What are lenalidomide capsules?” section for more information.
“The launch of our first generic version of Revlimid® in the U.S. provides patients with another important treatment option for these extremely challenging conditions, demonstrating Teva’s commitment to making complex generic drugs available to the patients who need them,” said Christine Baeder, SVP, Chief Operating Officer US Generics, Teva USA. “This product adds to our broad generic portfolio of oncology treatments, which accounts for 73% of the essential medicines in this category, as defined by the World Health Organization.”
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 12 generic prescriptions dispensed in the U.S. is filled with a Teva generic product.
Revlimid® had annual sales of $2.3 billion as of December 2021, according to IQVIA data.
What are lenalidomide capsules? Lenalidomide capsules are a prescription medicine, used to treat adults with:
Lenalidomide capsules should not be used to treat people who have chronic lymphocytic leukemia (CLL) unless they are participants in a controlled clinical trial.
It is not known if lenalidomide capsules are safe and effective in children.
What is the most important information I should know about lenalidomide capsules?
Before you begin taking lenalidomide capsules, you must read and agree to all of the instructions in the Lenalidomide REMS program. Before prescribing lenalidomide capsules, your healthcare provider will explain the Lenalidomide REMS program to you and have you sign the Patient-Physician Agreement Form.
Lenalidomide capsules may cause serious side effects including:
Females must not get pregnant:
Females who can become pregnant:
If you become pregnant while taking lenalidomide capsules, stop taking it right away and call your healthcare provider. If your healthcare provider is not available, you can call Customer Care Center at 1‐888‐423‐5436. Healthcare providers and patients should report all cases of pregnancy to:
There is a pregnancy exposure registry that monitors the outcomes of females who take lenalidomide capsules during pregnancy, or if their male partner takes lenalidomide capsules and they are exposed during pregnancy. You can enroll in this registry by calling the Lenalidomide REMS program at the phone number listed above.
Lenalidomide can pass into human semen:
Men, if your female partner becomes pregnant, you should call your healthcare provider right away.
Before taking lenalidomide capsules, tell your healthcare provider:
Who should not take lenalidomide capsules?
Do not take lenalidomide capsules if you:
What should I tell my healthcare provider before taking lenalidomide capsules?
Before you take lenalidomide capsules, tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Lenalidomide capsules and other medicines may affect each other, causing serious side effects. Talk with your healthcare provider before taking any new medicines.
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist.
What should I avoid while taking lenalidomide capsules?
What are the possible side effects of lenalidomide capsules?
Lenalidomide capsules can cause serious side effects, including:
Get emergency medical help right away if you develop any of the following signs or symptoms during treatment with lenalidomide capsules:
Your healthcare provider may tell you to decrease your dose, temporarily stop or permanently stop taking lenalidomide capsules if you develop certain serious side effects during treatment with lenalidomide capsules.
The most common side effects of lenalidomide capsules include:
These are not all the possible side effects of lenalidomide capsules. 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 including Boxed Warning.
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 specialty 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 specialty 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 regarding our generic version of Revlimid® (lenalidomide capsules), 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. Important factors that could cause or contribute to such differences include risks relating to:
1 Revlimid® is a registered trademark of Bristol Myers Squibb
IR Contacts United States Ran Meir (267) 468-4475 Israel Yael Ashman 972 (3) 914-8262
PR Contacts United States Kelley Dougherty (973) 658-0237 Yonatan Beker (973) 264 7378
IR Contacts United States Ran Meir (267) 468-4475 Israel Yael Ashman 972 (3) 914-8262
PR Contacts United States Kelley Dougherty (973) 658-0237 Yonatan Beker (973) 264 7378