Teva Announces Launch of Authorized Generic of Victoza® (liraglutide injection 1.8mg), in the United States

• Generic Victoza^® is the first-ever generic GLP-1 and supports increased demand for this category of therapies in the U.S. market.

• This launch adds to Teva’s continued commitment to its complex generic medicine portfolio.

• Liraglutide injection is indicated to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus and reduce the risk of cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease.

PARSIPPANY, N.J., June 24, 2024--(BUSINESS WIRE)--Teva Pharmaceuticals, Inc., a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), announced today the launch of an authorized generic of Victoza^®1 (liraglutide injection 1.8mg), in the United States.

"By launching an authorized generic for Victoza^® (liraglutide injection 1.8mg), we are providing patients with type 2 diabetes another option for this important treatment," said Ernie Richardsen, SVP, Head of U.S. Commercial Generics at Teva. "In addition to strengthening Teva's diverse complex generics portfolio, we are providing the first generic GLP-1 product to the U.S. marketplace, demonstrating once again our ability to sustain a generics powerhouse."

Victoza^® had annual sales of $1.656 billion as of April 2024.²

What is liraglutide injection?

Liraglutide is an injectable prescription medicine used:

• along with diet and exercise to lower blood sugar (glucose) in adults and children who are 10 years of age and older with type 2 diabetes mellitus.

• to reduce the risk of major cardiovascular events such as heart attack, stroke or death in adults with type 2 diabetes mellitus with known heart disease.

Liraglutide injection 1.8mg is not for use in people with type 1 diabetes. It should not be used with other medicines that contain liraglutide. It is not known if liraglutide injection is safe and effective to lower blood sugar (glucose) in children under 10 years of age.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about liraglutide injection?

Liraglutide injection may cause serious side effects, including:

• Possible thyroid tumors, including cancer. Tell your healthcare provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer. In studies with rats and mice, liraglutide injection and medicines that work like liraglutide injection caused thyroid tumors, including thyroid cancer. It is not known if liraglutide injection will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people.

• Do not use liraglutide injection if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC), or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

Who should not use liraglutide injection?

Do not use liraglutide injection if:

• you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

• you have had a serious allergic reaction to liraglutide or any of the ingredients in liraglutide injection. See the end of this Medication Guide for a complete list of ingredients in liraglutide injection. Symptoms of a serious allergic reaction include:

  • swelling of your face, lips, tongue or throat

  • problems breathing or swallowing

  • severe rash or itching

  • fainting or feeling dizzy

What should I tell my healthcare provider before using liraglutide injection?

Before using liraglutide injection, tell your healthcare provider if you have any other medical conditions, including if you:

• have or have had problems with your pancreas, kidneys, or liver.

• have severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems with digesting food.

• are pregnant or plan to become pregnant. It is not known if liraglutide injection will harm your unborn baby. Tell your healthcare provider if you become pregnant while using liraglutide injection.

• are breastfeeding or plan to breastfeed. It is not known if liraglutide injection passes into your breast milk. You should talk with your healthcare provider about the best way to feed your baby while using liraglutide injection.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Liraglutide injection may affect the way some medicines work and some medicines may affect the way liraglutide injection works.

Before using liraglutide injection, talk to your healthcare provider about low blood sugar and how to manage it. Tell your healthcare provider if you are taking other medicines to treat diabetes, including insulin or sulfonylureas. 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 liraglutide injection?

Liraglutide injection may cause serious side effects, including:

• inflammation of your pancreas (pancreatitis). Stop using liraglutide injection and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your abdomen to your back.

• low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use liraglutide injection with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin. In children who are 10 years of age and older, the risk for low blood sugar may be higher with liraglutide injection regardless of use with another medicine that can also lower blood sugar.

Signs and symptoms of low blood sugar may include:

• dizziness or light-headedness

• sweating

• confusion or drowsiness

• headache

• blurred vision

• slurred speech

• shakiness

• fast heartbeat

• anxiety, irritability, or mood changes

• hunger

• weakness

• feeling jittery
  

• kidney problems (kidney failure). In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration) which may cause kidney problems to get worse.

• serious allergic reactions. Stop using liraglutide injection and get medical help right away, if you have any symptoms of a serious allergic reaction including:

  • swelling of your face, lips, tongue or throat

  • problems breathing or swallowing

  • severe rash or itching

  • fainting or feeling dizzy

  • very rapid heartbeat

• gallbladder problems. Gallbladder problems have happened in some people who take liraglutide injection. Tell your healthcare provider right away if you get symptoms of gallbladder problems which may include:

  • pain in your upper stomach (abdomen)

  • fever

  • yellowing of skin or eyes (jaundice)

  • clay-colored stools

The most common side effects of liraglutide injection may include nausea, diarrhea, vomiting, decreased appetite, indigestion and constipation.

Talk to your healthcare provider about any side effects that bothers you or does not go away. These are not all the possible side effects of liraglutide injection.

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 full Prescribing Information including Boxed Warning and Medication Guide.

About Teva

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a global pharmaceutical leader with a category-defying portfolio, harnessing our generics expertise and stepping up innovation to continue the momentum behind the discovery, delivery, and expanded development of modern medicine. For over 120 years, Teva's commitment to bettering health has never wavered. Today, the company’s global network of capabilities enables its ~37,000 employees across 58 markets to push the boundaries of scientific innovation and deliver quality medicines to help improve health outcomes of millions of patients every day. To learn more about how Teva is all in for better health, visit 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 launch and commercial success of our authorized generic version to Victoza^® (liraglutide 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; our ability to develop and commercialize biopharmaceutical products; our ability to achieve expected results from investments in our product pipeline; our ability to develop and commercialize additional pharmaceutical products; our ability to successfully execute our 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; and other factors discussed in our Quarterly Report on Form 10-Q for the first quarter of 2024 and in our Annual Report on Form 10-K for the year ended December 31, 2023, 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.

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¹ Victoza^® is a registered trademark of Novo Nordisk.

² According to IQVIA data

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