Teva Announces FDA Approval and Launch of Generic Saxenda庐 (liraglutide injection) 鈥� First Generic GLP-1 Indicated for Weight Loss
Teva Pharmaceuticals (NYSE: TEVA) has received FDA approval and launched the first-ever generic version of Saxenda庐 (liraglutide injection), a GLP-1 receptor agonist for weight loss. This groundbreaking generic is indicated for adults with obesity or overweight with weight-related medical conditions, and pediatric patients aged 12-17 years weighing over 60 kg with obesity.
The approval marks Teva's fifth first-to-market generic entry this year, reinforcing their position as a Generics Powerhouse. The reference drug Saxenda庐 reported annual sales of $165 million as of June 2025, representing a significant market opportunity. The medication is designed to be used in combination with reduced calorie diet and increased physical activity for long-term weight management.
Teva Pharmaceuticals (NYSE: TEVA) ha ottenuto l'approvazione FDA e ha lanciato la prima versione generica di Saxenda庐 (iniezione di liraglutide), un agonista del recettore GLP-1 per la perdita di peso. Questo generico innovativo 猫 indicato per adulti con obesit脿 o sovrappeso con patologie correlate al peso e per pazienti pediatrici di et脿 12-17 anni con obesit脿 e peso superiore a 60 kg.
L'approvazione rappresenta il quinto lancio first-to-market di Teva quest'anno, consolidando il loro ruolo di protagonista nel settore dei generici. Il farmaco di riferimento Saxenda庐 ha registrato vendite annuali di 165 milioni di dollari a giugno 2025, offrendo un'importante opportunit脿 di mercato. Il medicinale 猫 pensato per essere utilizzato in combinazione con una dieta ipocalorica e un aumento dell'attivit脿 fisica per la gestione del peso a lungo termine.
Teva Pharmaceuticals (NYSE: TEVA) ha obtenido la aprobaci贸n de la FDA y ha lanzado la primera versi贸n gen茅rica de Saxenda庐 (inyecci贸n de liraglutida), un agonista del receptor GLP-1 para la p茅rdida de peso. Este gen茅rico pionero est谩 indicado para adultos con obesidad o sobrepeso con comorbilidades relacionadas con el peso y para pacientes pedi谩tricos de 12 a 17 a帽os con obesidad y m谩s de 60 kg de peso.
La aprobaci贸n marca la quinta entrada first-to-market de Teva este a帽o, reforzando su posici贸n como potencia en gen茅ricos. El f谩rmaco de referencia Saxenda庐 registr贸 ventas anuales de 165 millones de d贸lares hasta junio de 2025, lo que representa una importante oportunidad de mercado. El medicamento est谩 destinado a utilizarse junto con una dieta baja en calor铆as y mayor actividad f铆sica para el manejo del peso a largo plazo.
Teva Pharmaceuticals (NYSE: TEVA)臧� FDA 鞀轨澑鞚� 氚涥碃 觳挫 臧愲焿鞖� GLP-1 靾橃毄觳� 鞛戩毄鞝滌澑 Saxenda庐(毽澕旮�耄儉鞚措摐 欤检偓)鞚� 斓滌磮 鞝滊劋毽潉 於滌嫓頄堨姷雼堧嫟. 鞚� 須嶊赴鞝侅澑 鞝滊劋毽潃 牍勲 霕愲姅 觳挫 甏�霠� 歆堩櫂鞚� 鞛堧姅 靹膘澑瓿� 觳挫鞚� 60kg毳� 齑堦臣頃橂姅 12~17靹� 靻岇晞 牍勲 頇橃瀽鞐� 鞝侅潙歃濎澊 鞛堨姷雼堧嫟.
鞚措矆 項堦皜電� 鞓暣 Teva鞚� 雼れ劘 氩堨Ц 靹犾爯 鞝滊劋毽� 於滌嫓(first-to-market)搿�, 鞝滊劋毽� 攵勳暭鞐愳劀鞚� 鞙勳儊鞚� 臧曧檾頃╇媹雼�. 旮办 鞎诫 Saxenda庐電� 2025雲� 6鞗� 旮办 鞐瓣皠 毵れ稖 1鞏� 6,500毵� 雼煬毳� 旮半頃� 欷戩殧頃� 鞁滌灔 旮绊殞毳� 雮橅儉雰呺媹雼�. 鞚� 鞎诫鞚� 鞛リ赴 觳挫 甏�毽ゼ 鞙勴暣 鞝�旃茧毽� 鞁濍嫧 氚� 鞁犾泊 頇滊彊 歃濌皜鞕� 氤戩毄頃橂弰搿� 靹り硠霅橃棃鞀惦媹雼�.
Teva Pharmaceuticals (NYSE: TEVA) a obtenu l'autorisation de la FDA et lanc茅 la premi猫re version g茅n茅rique de Saxenda庐 (injection de liraglutide), un agoniste du r茅cepteur GLP鈥�1 pour la perte de poids. Ce g茅n茅rique novateur est indiqu茅 chez l'adulte en cas d'ob茅sit茅 ou de surpoids avec comorbidit茅s li茅es au poids et chez les adolescents de 12 脿 17 ans souffrant d'ob茅sit茅 pesant plus de 60 kg.
Cette autorisation constitue le cinqui猫me lancement first鈥憈o鈥憁arket de Teva cette ann茅e, renfor莽ant sa position de leader dans les g茅n茅riques. Le m茅dicament de r茅f茅rence Saxenda庐 a enregistr茅 165 millions de dollars de ventes annuelles en juin 2025, repr茅sentant une opportunit茅 de march茅 significative. Le traitement est destin茅 脿 锚tre utilis茅 en association avec un r茅gime hypocalorique et une augmentation de l'activit茅 physique pour la gestion du poids sur le long terme.
Teva Pharmaceuticals (NYSE: TEVA) hat die FDA-Zulassung erhalten und die erste generische Version von Saxenda庐 (Liraglutid-Injektion), einem GLP鈥�1鈥慠ezeptoragonisten zur Gewichtsreduktion, auf den Markt gebracht. Dieses bahnbrechende Generikum ist f眉r Erwachsene mit Adipositas oder 脺bergewicht und gewichtsbegleitenden Erkrankungen sowie f眉r p盲diatrische Patienten im Alter von 12鈥�17 Jahren mit Adipositas und einem K枚rpergewicht 眉ber 60 kg zugelassen.
Die Zulassung stellt Tevas f眉nften First鈥憈o鈥慚arket鈥慡tart in diesem Jahr dar und st盲rkt ihre Stellung als Generika鈥慞owerhouse. Das Referenzpr盲parat Saxenda庐 erzielte bis Juni 2025 Jahresums盲tze von 165 Millionen US鈥慏ollar, was ein erhebliches Marktpotenzial signalisiert. Das Medikament ist zur Anwendung in Kombination mit einer kalorienreduzierten Ern盲hrung und erh枚hter k枚rperlicher Aktivit盲t zur langfristigen Gewichtskontrolle bestimmt.
- First-ever generic GLP-1 receptor agonist approved for weight loss in the U.S.
- Fifth first-to-market generic entry for Teva in 2025, demonstrating R&D strength
- Addresses growing demand in the lucrative GLP-1/weight loss market
- Target drug Saxenda庐 has significant market size with $165M annual sales
- Significant safety concerns including risk of thyroid tumors and cancer
- Multiple serious side effects including pancreatitis, hypoglycemia, and gallbladder problems
- Complex patient monitoring requirements may affect adoption
Insights
Teva's first-to-market generic GLP-1 for weight loss represents significant market opportunity in rapidly growing obesity treatment landscape.
Teva's FDA approval for generic liraglutide injection marks a pivotal development in the highly competitive weight management pharmaceutical market. As the first-ever generic GLP-1 specifically indicated for weight loss, this represents a strategic entry into one of healthcare's fastest-growing segments.
The timing is particularly advantageous. GLP-1 receptor agonists have seen explosive demand in recent years, with branded products like Wegovy, Ozempic, and Saxenda facing supply constraints amid surging interest. Teva's generic will target the established
This launch aligns perfectly with Teva's broader strategy of focusing on complex generics with higher barriers to entry and less price erosion than conventional generics. The peptide-based injectable nature of liraglutide makes it significantly more challenging to produce than small-molecule generics, limiting potential competition.
This is Teva's fifth first-to-market generic entry this year, demonstrating remarkable regulatory execution and R&D capability in complex products. The approval strengthens Teva's position in the metabolic disease space while addressing a genuine market need for more affordable weight management options amid the ongoing obesity epidemic.
Generic Saxenda approval provides Teva immediate revenue opportunity and strengthens competitive position in high-value complex generics.
This approval represents a meaningful commercial opportunity for Teva, targeting a branded product with
The approval reinforces Teva's execution on its "Pivot to Growth Strategy" by expanding its complex generics portfolio. Unlike standard oral generics that face severe price erosion, complex injectable products like liraglutide typically maintain higher margins and face fewer competitors. First-to-market status provides additional competitive advantage, allowing Teva to establish market position before other generics enter.
From a financial perspective, this launch strengthens Teva's generics business, which has been under pressure in recent years. The company's focus on securing multiple first-to-market opportunities (five this year alone) demonstrates effective pipeline management and regulatory strategy execution.
While not transformative to Teva's overall financial profile given the company's
- Generic Saxenda庐 is the first-ever generic GLP-1 indicated for weight loss, addressing increased demand for this category of therapies in the U.S. market.
- This approval and launch add to Teva鈥檚 continued commitment to its complex generic medicine portfolio as part of its Pivot to Growth Strategy.
- Liraglutide injection is indicated for adults with obesity or overweight (excess weight) who also have weight related medical problems, and pediatric patients (12-17 years) with a weight greater than 60 kg and obesity to help them lose weight and keep the weight off.
PARSIPPANY, N.J., Aug. 28, 2025 (GLOBE NEWSWIRE) -- Teva Pharmaceuticals, Inc., a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), announced today the FDA approval and U.S. launch of a generic version of Saxenda庐1 (liraglutide injection).
鈥淲ith this approval, and by launching a generic for Saxenda庐 (liraglutide injection), we will provide patients in the U.S. the first ever generic GLP-1 product specifically indicated for weight loss,鈥� said Ernie Richardsen, SVP, Head of U.S. Commercial Generics at Teva. 鈥淭his is the fifth first-to-market entry of a Teva generic this year and is an important addition to Teva's diverse聽complex generics portfolio, demonstrating once again our proven ability to sustain a world class Generics Powerhouse.鈥�
Saxenda庐 had annual sales of
What is Liraglutide Injection?
Liraglutide Injection is a glucagon like peptide 1 (GLP-1) receptor agonist indicated in combination with a reduced calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in:
- Adults and pediatric patients aged 12 years and older with body weight greater than 60 kg and obesity.
- Adults with overweight in the presence of at least one weight-related comorbid condition.
- Liraglutide injection should be used with a reduced calorie diet and increased physical activity.
- Liraglutide injection is not recommended for people who also take liraglutide or other medicines called glucagon-like peptide-1 (GLP-1) receptor agonists.
- It is not known if liraglutide injection is safe and effective in children under 12 years of age.
- It is not known if liraglutide injection is safe and effective in children aged 12 to 17 years with type 2 diabetes.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about liraglutide injection?
Serious side effects may happen in people who take liraglutide injection, 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 take liraglutide injection?
Do not receive 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 鈥�What are the possible side effects of liraglutide injection?鈥� for symptoms of a serious allergic reaction.
Before taking liraglutide injection tell your healthcare provider about all of your medical conditions, including if you:
- have or have had problems with your pancreas
- have severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems with digesting food.
- are scheduled to have surgery or other procedures that use anesthesia or deep sleepiness (deep sedation).
- have or have had depression or suicidal thoughts, or mental health issues.
- are breastfeeding or plan to breastfeed. It is not known if liraglutide passes into your breast milk. You and your healthcare provider should decide if you will use liraglutide injection or breastfeed.
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 other medicines may affect the way liraglutide injection works.
Tell your healthcare provider if you take diabetes medicines, especially insulin and sulfonylurea medicines. Talk with your healthcare provider if you are not sure if you take any of these medicines. Know the medicines you take. Keep a list 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 the 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 stomach area (abdomen) to your back
- increased risk of low blood sugar (hypoglycemia) in adults with type 2 diabetes especially those who also take medicines to treat type 2 diabetes mellitus such as an insulin or a sulfonylureas and in children who are 12 years of age and older without type 2 diabetes mellitus. Low blood sugar in patients with adults with type 2 diabetes and in children without type 2 diabetes mellitus who receive liraglutide injection can be both a serious and common side effect. Talk to your healthcare provider about how to recognize and treat low blood sugar. You should check your blood sugar before you start taking liraglutide injection and while you take liraglutide injection.
- 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
Talk to your healthcare provider about how to recognize and treat low blood sugar. You should check your blood sugar before you start taking liraglutide injection and while you take liraglutide injection.
- increased heart rate. Liraglutide injection can increase your heart rate while you are at rest. Your healthcare provider should check your heart rate while you take liraglutide injection. Tell your healthcare provider if you feel your heart racing or pounding in your chest and it lasts for several minutes.
- dehydration leading to kidney problems. Diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration) which may cause kidney problems. It is important for you to drink聽fluids to help reduce your chance of dehydration. Tell your healthcare provider right away if you have nausea, vomiting, or diarrhea that does not go away
- severe stomach problems. Stomach problems, sometimes severe, have been reported in people who use liraglutide injection. Tell your healthcare provider if you have stomach problems that are severe or will not go away.
- 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. Liraglutide injection may cause gallbladder problems including gallstones. Some gallbladder problems need surgery. Call your healthcare provider if you have any of the following symptoms:
- pain in your upper stomach (abdomen)
- fever
- yellowing of your skin or eyes (jaundice)
- clay-colored stools
- depression or thoughts of suicide. You should pay attention to any mental changes, especially sudden changes, in your mood, behaviors, thoughts, or feelings. Call your healthcare provider right away if you have any mental changes that are new, worse, or worry you.
- food or liquid getting into the lungs during surgery or other procedures that use anesthesia or deep sleepiness (deep sedation). Liraglutide injection may increase the chance of food getting into your lungs during surgery or other procedures. Tell all your healthcare providers that you are taking liraglutide injection before you are scheduled to have surgery or other procedures.
The most common side effects of liraglutide injection in adults include:
- nausea
- diarrhea
- constipation
- vomiting
- injection site reaction
- low blood sugar (hypoglycemia)
- headache
- upset stomach (dyspepsia)
- tiredness (fatigue)
- dizziness
- stomach pain
- change in enzyme (lipase) levels in your blood
Additional common side effects in children are fever and gastroenteritis.
Talk to your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of liraglutide injection. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Please read the Medication Guide in the full , including Boxed Warning.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a leading innovative biopharmaceutical company, enabled by a world-class generics business. For over 120 years, Teva鈥檚 commitment has never wavered. From innovating in the fields of neuroscience and immunology to providing complex generic medicines, biosimilars and pharmacy brands worldwide, Teva is dedicated to addressing patients鈥� needs, now and in the future. At Teva, We Are All In For Better Health. To learn more about how, visit .
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鈥檚 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 鈥渟hould,鈥� 鈥渆xpect,鈥� 鈥渁nticipate,鈥� 鈥渆stimate,鈥� 鈥渢arget,鈥� 鈥渕ay,鈥� 鈥減roject,鈥� 鈥済uidance,鈥� 鈥渋ntend,鈥� 鈥減lan,鈥� 鈥渂elieve鈥� 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 Saxenda庐 (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; competition faced by our generic medicines from other pharmaceutical companies and changes in regulatory policy that may result in additional costs and delays; delays in launches of new generic products; 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 other factors discussed in this press release, in our Quarterly Report on Form 10-Q for the second quarter of 2025 and in our Annual Report on Form 10-K for the year ended December 31, 2024, including in the section captioned 鈥淩isk Factors.鈥� 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 Saxenda庐 is a registered trademark of Novo Nordisk.
2 According to IQVIA data
FAQ
What is significant about Teva's generic Saxenda庐 (liraglutide) approval?
What are the approved indications for Teva's generic liraglutide injection?
What is the market size for Saxenda庐 that Teva's generic will target?
What are the main safety concerns for Teva's generic liraglutide?
How does this approval align with Teva's business strategy?
