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Dr. Reddy's Laboratories and Senores Pharmaceuticals, Inc. Announce the Launch of Ivermectin Tablets USP, 3 mg in US Market

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Dr. Reddy's Laboratories and Senores Pharmaceuticals announced the launch of Ivermectin Tablets USP, 3 mg in the US market. The product is bioequivalent to STROMECTOL® Tablets of Merck Sharp and Dohme Dr. Reddy's will market the product, with Senores being the second generic manufacturer to receive approval. The Ivermectin Tablets market, including both brand and generic products, had US sales of approximately $20 million for the twelve months ending September 2024, according to IQVIA data.

Dr. Reddy's Laboratories e Senores Pharmaceuticals hanno annunciato il lancio delle Compresse di Ivermectina USP, 3 mg sul mercato statunitense. Il prodotto è bioequivalente alle Compresse STROMECTOL® di Merck Sharp and Dohme. Dr. Reddy's commercializzerà il prodotto, con Senores che sarà il secondo produttore generico a ricevere approvazione. Il mercato delle Compresse di Ivermectina, che include sia prodotti di marca che generici, ha registrato vendite negli Stati Uniti di circa 20 milioni di dollari per i dodici mesi conclusisi a settembre 2024, secondo i dati di IQVIA.

Dr. Reddy's Laboratories y Senores Pharmaceuticals anunciaron el lanzamiento de las Tabletas de Ivermectina USP, 3 mg en el mercado estadounidense. El producto tiene el mismo efecto que las Tabletas STROMECTOL® de Merck Sharp and Dohme. Dr. Reddy's comercializará el producto, siendo Senores el segundo fabricante genérico en recibir aprobación. El mercado de Tabletas de Ivermectina, que incluye tanto productos de marca como genéricos, tuvo ventas en EE. UU. de aproximadamente 20 millones de dólares durante los doce meses hasta septiembre de 2024, según datos de IQVIA.

Dr. Reddy's Laboratories와 Senores Pharmaceuticals는 미국 시장에 3mg 이버멕틴 정제 USP 출시를 발표했습니다. 이 제품은 Merck Sharp and Dohme의 STROMECTOL® 정제와 동일한 생물학적 동등성을 가지고 있습니다. Dr. Reddy's가 제품을 마케팅하며, Senores는 승인을 받은 두 번째 제네릭 제조업체가 됩니다. 이버멕틴 정제 시장은 브랜드와 제네릭 제품을 포함하여 2024년 9월에 종료된 12개월 동안 미국에서 약 2천만 달러의 매출을 기록했습니다. 이는 IQVIA 데이터에 따른 것입니다.

Dr. Reddy's Laboratories et Senores Pharmaceuticals ont annoncé le lancement des Tablettes d'Ivermectine USP, 3 mg sur le marché américain. Le produit est bioéquivalent aux Tablettes STROMECTOL® de Merck Sharp and Dohme. Dr. Reddy's commercialisera le produit, Senores étant le deuxième fabricant générique à recevoir l'approbation. Le marché des Tablettes d'Ivermectine, comprenant à la fois des produits de marque et génériques, a réalisé des ventes aux États-Unis d'environ 20 millions de dollars pour les douze mois se terminant en septembre 2024, selon les données d'IQVIA.

Dr. Reddy's Laboratories und Senores Pharmaceuticals gaben die Einführung der Ivermectin-Tabletten USP, 3 mg auf dem US-Markt bekannt. Das Produkt ist bioäquivalent zu den STROMECTOL®-Tabletten von Merck Sharp and Dohme. Dr. Reddy's wird das Produkt vermarkten, wobei Senores der zweite Generikahersteller ist, der die Genehmigung erhalten hat. Der Markt für Ivermectin-Tabletten, einschließlich Marken- und Generikaprodukten, erzielte laut IQVIA-Daten im Zeitraum von zwölf Monaten bis September 2024 in den USA einen Umsatz von etwa 20 Millionen Dollar.

Positive
  • Entry into -competition market as second generic manufacturer
  • Access to $20 million market opportunity in the US
  • Strategic expansion in niche product segment
Negative
  • None.

Insights

The launch of generic Ivermectin represents a modest but strategic opportunity for Dr. Reddy's. With a total market size of $20 million and being only the second generic entrant, this launch could capture meaningful market share. Generic manufacturers typically secure 20-30% of the market initially, suggesting potential annual revenues of $4-6 million. While relatively small compared to RDY's overall revenue base, the competition nature of this product should provide healthy margins. The partnership with Senores Pharmaceuticals demonstrates RDY's continued execution of its strategy to target niche, high-margin opportunities in the U.S. generics market.

HYDERABAD, India--(BUSINESS WIRE)-- Dr. Reddy's Laboratories, Inc. and Senores Pharmaceuticals, Inc. today announced the launch of Ivermectin Tablets USP, 3 mg, which is bioequivalent and therapeutically equivalent to STROMECTOL® Tablets of Merck Sharp and Dohme LLC in the U.S. market. The product will be marketed by Dr. Reddy's.

“We are pleased to advance our growth with the launch of a limited-competition product. With our continuous focus on niche opportunities, we are proud to be the second generic to receive approval for this product,” stated Swapnil Shah, Managing Director, Senores Pharmaceuticals Limited.

Ivermectin Tablets, 3 mg brand and generic products, had U.S. sales of approximately $20 million MAT for the twelve months ending in September 2024 according to IQVIA.

RDY-1124-747

About Dr. Reddy’s: Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY) is a global pharmaceutical company headquartered in Hyderabad, India. Established in 1984, we are committed to providing access to affordable and innovative medicines. Driven by our purpose of ‘Good Health Can’t Wait’, we offer a portfolio of products and services including APIs, generics, branded generics, biosimilars and OTC. Our major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Our major markets include – USA, India, Russia & CIS countries, China, Brazil and Europe. As a company with a history of deep science that has led to several industry firsts, we continue to plan ahead and invest in businesses of the future. As an early adopter of sustainability and ESG actions, we released our first Sustainability Report in 2004. Our current ESG goals aim to set the bar high in environmental stewardship; access and affordability for patients; diversity; and governance. For more information, log on to: www.drreddys.com.

About Senores Pharmaceuticals, Inc.: Senores Pharmaceuticals, Inc., based in Georgia, USA, is a wholly owned subsidiary of Senores Pharmaceuticals Limited and one of the fastest-growing pharmaceutical companies in the USA. The company has more than 25 products commercially launched or filed with the USFDA. For more information about Senores Pharmaceuticals, Inc., please visit www.senorespharma.com.

Disclaimer: This press release may include statements of future expectations and other forward-looking statements that are based on the management’s current views and assumptions and involve known or unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. In addition to statements which are forward-looking by reason of context, the words "may", "will", "should", "expects", "plans", "intends", "anticipates", "believes", "estimates", "predicts", "potential", or "continue" and similar expressions identify forward-looking statements. Actual results, performance or events may differ materially from those in such statements due to without limitation, (i) general economic conditions such as performance of financial markets, credit defaults, currency exchange rates, interest rates, persistency levels and frequency / severity of insured loss events, (ii) mortality and morbidity levels and trends, (iii) changing levels of competition and general competitive factors, (iv) changes in laws and regulations and in the policies of central banks and/or governments, (v) the impact of acquisitions or reorganization, including related integration issues, and (vi) the susceptibility of our industry and the markets addressed by our, and our customers’, products and services to economic downturns as a result of natural disasters, epidemics, pandemics or other widespread illness, including coronavirus (or COVID-19), and (vii) other risks and uncertainties identified in our public filings with the Securities and Exchange Commission, including those listed under the "Risk Factors" and "Forward-Looking Statements" sections of our Annual Report on Form 20-F for the year ended March 31, 2022. The company assumes no obligation to update any information contained herein.

INVESTOR RELATIONS

RICHA PERIWAL

RICHAPERIWAL@drreddys.com

MEDIA RELATIONS

USHA IYER

USHAIYER@DRREDDYS.COM

Source: Dr. Reddy's Laboratories, Inc.

FAQ

What is the market size for Ivermectin Tablets that Dr. Reddy's (RDY) is entering?

According to IQVIA data, the US market size for Ivermectin Tablets (3 mg), including both brand and generic products, was approximately $20 million MAT for the twelve months ending September 2024.

Is Dr. Reddy's (RDY) the first generic manufacturer of Ivermectin Tablets in the US?

No, Dr. Reddy's and Senores Pharmaceuticals are the second generic manufacturer to receive approval for Ivermectin Tablets USP, 3 mg in the US market.

What is the reference brand product for Dr. Reddy's (RDY) Ivermectin Tablets?

The reference brand product is STROMECTOL® Tablets manufactured by Merck Sharp and Dohme

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