Teva Announces Launch of a Generic Version of NuvaRing® (etonogestrel and ethinyl estradiol) Vaginal Ring in the United States
TEL AVIV, Israel & PARSIPPANY, N.J.--(BUSINESS WIRE)--Teva Pharmaceuticals USA, Inc., a U.S. affiliate of Teva Pharmaceutical Industries Ltd.(NYSE and TASE: TEVA), today announced the availability of a generic version of NuvaRing®1 (etonogestrel and ethinyl estradiol vaginal ring), 0.120 mg/0.015 mg per day, in the U.S. Teva’s AB-rated and bioequivalent etonogestrel and ethinyl estradiol vaginal ring, is an estrogen/progestin combination hormonal contraceptive (CHC) indicated for use by women to prevent pregnancy.
“The launch of a generic version of NuvaRing Vaginal Ring in the U.S. is an important addition to Teva’s generic portfolio,” said Christine Baeder, SVP, Chief Operating Officer US Generics, Teva USA. “With more than 40 generic products in our existing woman’s health portfolio, we are proud to add another accessible contraception option.”
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 over 100 pending first-to-files in the U.S. Currently, one in ten generic prescriptions dispensed in the U.S. is filled with a Teva generic product.
Etonogestrel and ethinyl estradiol vaginal ring products have annual sales of more than $837 million in the U.S., according to IQVIA data as of November 2020.
About Etonogestrel and Ethinyl Estradiol Vaginal Ring
Etonogestrel and ethinyl estradiol vaginal ring is indicated for use by females of reproductive age to prevent pregnancy. Etonogestrel and ethinyl estradiol is a flexible birth control vaginal ring inserted in the vagina. The ring is to remain in place for 3 weeks (21 days). It is removed for one week (7 days) and a new vaginal ring is inserted on the same day of the week it was inserted in the previous cycle.
Etonogestrel and ethinyl estradiol vaginal ring contains a combination of a progestin and estrogen, 2 kinds of female hormones. Birth control methods that contain both an estrogen and a progestin are called combination hormonal contraceptives (CHCs).
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about etonogestrel and ethinyl estradiol vaginal ring?
Do not use etonogestrel and ethinyl estradiol vaginal ring if you smoke cigarettes and are over 35 years old. Smoking increases your risk of serious cardiovascular side effects (heart and blood vessel problems) from combination hormonal contraceptives (CHCs), including death from heart attack, blood clots or stroke. This risk increases with age and the number of cigarettes you smoke.
Hormonal birth control methods help to lower the chances of becoming pregnant. They do not protect against HIV infection (AIDS) and other sexually transmitted infections.
How well does etonogestrel and ethinyl estradiol vaginal ring work?
Your chance of getting pregnant depends on how well you follow the directions for using etonogestrel and ethinyl estradiol vaginal ring. The better you follow the directions, the less chance you have of getting pregnant.
Based on the results of a US clinical study, approximately 1 to 3 women out of 100 women may get pregnant during the first year they use etonogestrel and ethinyl estradiol vaginal ring.
Who should not use etonogestrel and ethinyl estradiol vaginal ring?
Do not use etonogestrel and ethinyl estradiol vaginal ring if you:
- smoke and are over 35 years old
- have or have had blood clots in your arms, legs, eyes, or lungs
- have an inherited problem with your blood that makes it clot more than normal
- have had a stroke
- have had a heart attack
- have certain heart valve problems or heart rhythm problems that can cause blood clots to form in the heart
- have high blood pressure that medicine can't control
- have diabetes with kidney, eye, nerve, or blood vessel damage
- have certain kinds of severe migraine headaches with aura, numbness, weakness, or changes in vision, or have any migraine headaches if you are over age 35
- have liver disease, including liver tumors
- take any Hepatitis C drug combination containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir. This may increase levels of the liver enzyme “alanine aminotransferase” (ALT) in the blood
- have unexplained vaginal bleeding
- are pregnant or think you may be pregnant. Etonogestrel and ethinyl estradiol vaginal ring is not for pregnant women
- have or have had breast cancer or any cancer that is sensitive to female hormones
- are allergic to etonogestrel, ethinyl estradiol or any of the ingredients in etonogestrel and ethinyl estradiol vaginal ring. See the list of ingredients in etonogestrel and ethinyl estradiol vaginal ring at the end of this leaflet
Hormonal birth control methods may not be a good choice for you if you have ever had jaundice (yellowing of the skin or eyes) caused by pregnancy or related to previous use of hormonal birth control.
Tell your healthcare provider if you have ever had any of the conditions listed above. Your healthcare provider can suggest another method of birth control.
What should I tell my healthcare provider before using etonogestrel and ethinyl estradiol vaginal ring?
Before you use etonogestrel and ethinyl estradiol vaginal ring tell your healthcare provider if you:
- have any medical conditions
- are pregnant or think you are pregnant
- recently had a baby
- recently had a miscarriage or abortion
- have a family history of breast cancer
- have or have had breast nodules, fibrocystic disease, an abnormal breast x-ray, or abnormal mammogram
- use tampons and have a history of toxic shock syndrome
- have been diagnosed with depression
- have had liver problems including jaundice during pregnancy
- have or have had elevated cholesterol or triglycerides
- have or have had gallbladder, liver, heart, or kidney disease
- have diabetes
- have a history of jaundice (yellowing of the skin or eyes) caused by pregnancy (also called cholestasis of pregnancy)
- have a history of scanty or irregular menstrual periods
- have any condition that makes the vagina become irritated easily
- have or have had high blood pressure
- have or have had migraines or other headaches or seizures
- are scheduled for surgery. Etonogestrel and ethinyl estradiol vaginal ring may increase your risk of blood clots after surgery. You should stop using etonogestrel and ethinyl estradiol vaginal ring at least 4 weeks before you have surgery and not restart it until at least 2 weeks after your surgery
- are scheduled for any laboratory tests. Certain blood tests may be affected by hormonal birth control methods
- are breastfeeding or plan to breastfeed. Hormonal birth control methods that contain estrogen, like etonogestrel and ethinyl estradiol vaginal ring, may decrease the amount of milk you make. A small amount of hormones from etonogestrel and ethinyl estradiol vaginal ring may pass into your breast milk. Consider another non-hormonal method of birth control until you are ready to stop breastfeeding
- have (or have ever had) an allergic reaction while using etonogestrel and ethinyl estradiol vaginal ring, including hives, swelling of the face, lips, tongue, and/or throat causing difficulty in breathing or swallowing (anaphylaxis and/or angioedema)
Tell your healthcare provider about all medicines and herbal products you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.
Some medicines and herbal products may make hormonal birth control less effective, including, but not limited to:
- certain anti-seizure medicines (such as barbiturates, carbamazepine, felbamate, oxcarbazepine, phenytoin, rufinamide and topiramate)
- medicine to treat fungal infections (griseofulvin)
- certain combinations of HIV medicines, (such as nelfinavir, ritonavir, darunavir/ritonavir, (fos)amprenavir/ritonavir, lopinavir/ritonavir, and tipranavir/ritonavir)
- certain hepatitis C (HCV) medicines (such as boceprevir and telaprevir)
- non-nucleoside reverse transcriptase inhibitors (such as efavirenz and nevirapine)
- medicine to treat tuberculosis (such as rifampicin and rifabutin)
- medicine to treat high blood pressure in the vessels of the lung (bosentan)
- medicine to treat chemotherapy-induced nausea and vomiting (aprepitant)
- St John’s wort
Use an additional barrier contraceptive method (such as a male condom with spermicide) when you take medicines that may make etonogestrel and ethinyl estradiol vaginal ring less effective. Since the effect of another medicine on etonogestrel and ethinyl estradiol vaginal ring may last up to 28 days after stopping the medicine, it is necessary to use the additional barrier contraceptive method for that long to help prevent you from becoming pregnant. While using etonogestrel and ethinyl estradiol vaginal ring, you should not use certain female barrier contraceptive methods such as a vaginal diaphragm, cervical cap or female condom as your back-up method of birth control because etonogestrel and ethinyl estradiol vaginal ring may interfere with the correct placement and position of a diaphragm, cervical cap or female condom.
Some medicines and grapefruit juice may increase the level of ethinyl estradiol in your blood if used together, including:
- the pain reliever acetaminophen
- ascorbic acid (vitamin C)
- medicines that affect how your liver breaks down other medicines (such as itraconazole, ketoconazole, voriconazole, fluconazole, clarithromycin, erythromycin, and diltiazem)
- certain HIV medicines (atazanavir/ritonavir and indinavir)
- non-nucleoside reverse transcriptase inhibitors (such as etravirine)
- medicines to lower cholesterol such as atorvastatin and rosuvastatin
Hormonal birth control methods may interact with lamotrigine, a medicine used for seizures. This may increase the risk of seizures, so your healthcare provider may need to adjust your dose of lamotrigine.
Women on thyroid replacement therapy may need increased doses of thyroid hormone.
Ask your healthcare provider if you are not sure if you take any of the medicines listed above. Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.
What are the possible side effects of using etonogestrel and ethinyl estradiol vaginal ring?
See “What is the most important information I should know about etonogestrel and ethinyl estradiol vaginal ring?”
Etonogestrel and ethinyl estradiol vaginal ring may cause serious side effects, including:
blood clots. Like pregnancy, combination hormonal birth control methods increase the risk of serious blood clots (see following graph), especially in women who have other risk factors, such as smoking, obesity, or age greater than 35. This increased risk is highest when you first start using a combination hormonal birth control method or when you restart the same or different combination hormonal birth control method after not using it for a month or more. Talk with your healthcare provider about your risk of getting a blood clot before using etonogestrel and ethinyl estradiol vaginal ring or before deciding which type of birth control is right for you.
In some studies of women who used etonogestrel and ethinyl estradiol vaginal ring, the risk of getting a blood clot was similar to the risk in women who used combination birth control pills.
Other studies have reported that the risk of blood clots was higher for women who use combination birth control pills containing desogestrel (a progestin similar to the progestin in etonogestrel and ethinyl estradiol vaginal ring) than for women who use combination birth control pills that do not contain desogestrel.
It is possible to die or be permanently disabled from a problem caused by a blood clot, such as heart attack or stroke. Some examples of serious blood clots are blood clots in the:
- legs (deep vein thrombosis)
- lungs (pulmonary embolus)
- eyes (loss of eyesight)
- heart (heart attack)
- brain (stroke)
Call your healthcare provider right away if you have:
- leg pain that does not go away
- sudden shortness of breath
- sudden blindness, partial or complete
- severe pain or pressure in your chest
- sudden, severe headache unlike your usual headaches
- weakness or numbness in an arm or leg, or trouble speaking
- yellowing of the skin or eyeballs
Other serious risks include:
- Toxic Shock Syndrome (TSS). Some of the symptoms are much the same as the flu, but they can become serious very quickly. Call your healthcare provider or get emergency treatment right away if you have the following symptoms:
- allergic reaction, including hives, swelling of the face, lips, tongue, and/or throat causing difficulty in breathing or swallowing (anaphylaxis and/or angioedema)
- liver problems, including liver tumors
- high blood pressure
- gallbladder problems
- accidental insertion into bladder
- symptoms of a problem called angioedema if you already have a family history of angioedema
The most common side effects of etonogestrel and ethinyl estradiol vaginal ring are:
- tissue irritation inside your vagina or on your cervix
- headache (including migraine)
- mood changes (including depression, especially if you had depression in the past). Call your healthcare provider immediately if you have any thoughts of harming yourself.
- etonogestrel and ethinyl estradiol vaginal ring problems, including the ring slipping out or causing discomfort
- nausea and vomiting
- vaginal discharge
- weight gain
- vaginal discomfort
- breast pain, discomfort, or tenderness
- painful menstrual periods
- abdominal pain
- less sexual desire
Some women have spotting or light bleeding during etonogestrel and ethinyl estradiol vaginal ring use. If these symptoms occur, do not stop using etonogestrel and ethinyl estradiol vaginal ring. The problem will usually go away. If it doesn’t go away, check with your healthcare provider.
Other side effects seen with etonogestrel and ethinyl estradiol vaginal ring include breast discharge; vaginal injury (including pain, discomfort, and bleeding) associated with broken rings; and penis discomfort of the partner (such as irritation, rash, itching).
Less common side effects seen with combination hormonal birth control include:
- Blotchy darkening of your skin, especially on your face
- High blood sugar, especially in women who already have diabetes
- High fat (cholesterol, triglycerides) levels in the blood
There have been reports of the ring becoming stuck to the vaginal tissue and having to be removed by a healthcare provider. Call your healthcare provider if you are unable to remove your etonogestrel and ethinyl estradiol vaginal ring.
Tell your healthcare provider about any side effect that bothers you or that does not go away. These are not all the possible side effects of etonogestrel and ethinyl estradiol vaginal ring. For more information, ask your healthcare provider or pharmacist. Call your healthcare provider for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please read the Patient Information Leaflet in the accompanying full Prescribing Information and Boxed Warning.
For more information, please see accompanying full Prescribing Information, including the Boxed Warning. A copy may be requested from Teva U.S. Medical Information at 888-TEVA-USA (888-838-2872), email@example.com, or Teva’s Public Relations or Investor Relations contacts.
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 regarding the launch of our generic version of NuvaRing® (etonogestrel and ethinyl estradiol) vaginal ring in the United States, 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. Important factors that could cause or contribute to such differences include risks relating to:
- the commercial success of our generic version of NuvaRing® (etonogestrel and ethinyl estradiol) vaginal ring;
- our ability to successfully compete in the marketplace, including: that we are substantially dependent on our generic products; consolidation of our customer base and commercial alliances among our customers; the increase in the number of competitors targeting generic opportunities and seeking U.S. market exclusivity for generic versions of significant products; competition for our specialty products, especially COPAXONE®, our leading medicine, which faces competition from existing and potential additional generic versions, competing glatiramer acetate products and orally-administered alternatives; the uncertainty of commercial success of AJOVY® or AUSTEDO®; competition from companies with greater resources and capabilities; delays in launches of new products and our ability to achieve expected results from investments in our product pipeline; ability to develop and commercialize biopharmaceutical products; efforts of pharmaceutical companies to limit the use of generics, including through legislation and regulations and the effectiveness of our patents and other measures to protect our intellectual property rights;
- our substantial indebtedness, which may limit our ability to incur additional indebtedness, engage in additional transactions or make new investments, may result in a further downgrade of our credit ratings; and our inability to raise debt or borrow funds in amounts or on terms that are favorable to us;
- our business and operations in general, including: uncertainty regarding the magnitude, duration, and geographic reach of the COVID-19 pandemic and its impact on our business, financial condition, operations, cash flows, and liquidity and on the economy in general; our ability to successfully execute and maintain the activities and efforts related to the measures we have taken or may take in response to the COVID-19 pandemic and associated costs therewith; effectiveness of our restructuring plan announced in December 2017; our ability to attract, hire and retain highly skilled personnel; our ability to develop and commercialize additional pharmaceutical products; compliance with anti-corruption sanctions and trade control laws; manufacturing or quality control problems; interruptions in our supply chain, including due to potential effects of the COVID-19 pandemic on our operations and business in geographic locations impacted by the pandemic and on the business operations of our suppliers; disruptions of information technology systems; breaches of our data security; variations in intellectual property laws; challenges associated with conducting business globally, including adverse effects of the COVID-19 pandemic, political or economic instability, major hostilities or terrorism; significant sales to a limited number of customers; our ability to successfully bid for suitable acquisition targets or licensing opportunities, or to consummate and integrate acquisitions; our prospects and opportunities for growth if we sell assets; and potential difficulties related to the operation of our new global enterprise resource planning (ERP) system;
- compliance, regulatory and litigation matters, including: our ability to successfully defend against the U.S. Department of Justice criminal charges of Sherman Act violations; increased legal and regulatory action in connection with public concern over the abuse of opioid medications in the U.S. and our ability to reach a final resolution of the remaining opioid-related litigation; costs and delays resulting from the extensive governmental regulation to which we are subject or delays in governmental processing time due to modified government operations due to the COVID-19 pandemic, including effects on product and patent approvals due to the COVID-19 pandemic; the effects of reforms in healthcare regulation and reductions in pharmaceutical pricing, reimbursement and coverage; governmental investigations into S&M practices; potential liability for patent infringement; product liability claims; increased government scrutiny of our patent settlement agreements; failure to comply with complex Medicare and Medicaid reporting and payment obligations; and environmental risks;
- other financial and economic risks, including: our exposure to currency fluctuations and restrictions as well as credit risks; potential impairments of our intangible assets; potential significant increases in tax liabilities; and the effect on our overall effective tax rate of the termination or expiration of governmental programs or tax benefits, or of a change in our business;
and other factors discussed in this press release, in our Quarterly Reports on Form 10-Q for the first, second and third quarters of 2020 and in our Annual Report on Form 10-K for the year ended December 31, 2019, including in the sections captioned "Risk Factors” and “Forward Looking Statements.” 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 NuvaRingis a registered trademark of Merck Sharp & Dohme B.V., a subsidiary of Merck & Co., Inc.
Kevin C. Mannix
972 (3) 914-8262
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