Dr. Reddy's to Launch Generic Ozempic in Canada Soon
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 20 hours ago
0mins
Source: seekingalpha
- First Generic Launch: Dr. Reddy's Laboratories is set to launch its generic version of Ozempic in Canada within the next few days, becoming the first company to sell this product in the country, marking the beginning of market competition.
- Pricing Strategy: CEO Erez Israeli stated that Dr. Reddy's will introduce the drug at a 'very healthy price,' although specific pricing details were not disclosed; initial prices are expected to be higher but may decrease as competition increases.
- Regulatory Approval Progress: Despite an initial rejection last year, Canada's drug regulator approved Dr. Reddy's marketing application for Ozempic in late April, making it the first generic approved in a G7 nation.
- Intensifying Market Competition: With Apotex also receiving approval for Ozempic and planning to launch by the end of May, more competitors are expected to enter the market, likely putting pressure on Novo Nordisk's market share.
Trade with 70% Backtested Accuracy
Stop guessing "Should I Buy RDY?" and start using high-conviction signals backed by rigorous historical data.
Sign up today to access powerful investing tools and make smarter, data-driven decisions.
Analyst Views on RDY
About RDY
Dr. Reddy’s Laboratories Limited is an India-based pharmaceutical company. Its products and services are spread across its core businesses of active pharmaceutical ingredients (APIs), generics, branded generics, biosimilars and over-the-counter (OTC) pharmaceutical products. It works in the areas of gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Its segments consist of Global Generics; Pharmaceutical Services and Active Ingredients (PSAI), and Others. The Global Generics segment consists of the Company's business of manufacturing and marketing prescription and over-the-counter finished pharmaceutical products ready for consumption by the patient, marketed under a brand name (branded formulations) or as generic finished dosages with therapeutic equivalence to branded formulations (generics). The Pharmaceutical Services and Active Ingredients segment consists of the Company's business of manufacturing and marketing APIs and intermediates.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Dr. Reddy's Q4 Earnings Miss Expectations
- Disappointing Earnings: Dr. Reddy's reported Q4 GAAP EPS of $0.03, falling short of expectations, with revenue of $801 million reflecting an 11.7% year-over-year decline, indicating significant profitability challenges ahead.
- Significant Revenue Shortfall: The revenue missed analyst expectations by $54.01 million, which could undermine investor confidence and negatively impact the company's future financial outlook.
- Drug Review Progress: Dr. Reddy's biosimilar is currently under FDA review, and despite facing challenges, successful approval could provide new revenue streams and enhance competitive positioning in the market.
- Rating Downgrade Impact: Immutep's downgrade following a late-stage trial setback for its lead drug may trigger a ripple effect across the biopharmaceutical sector, prompting Dr. Reddy's to remain vigilant regarding market dynamics as an industry player.
See More
Dr. Reddy's to Launch Generic Ozempic in Canada Soon
- First Generic Launch: Dr. Reddy's Laboratories is set to launch its generic version of Ozempic in Canada within the next few days, becoming the first company to sell this product in the country, marking the beginning of market competition.
- Pricing Strategy: CEO Erez Israeli stated that Dr. Reddy's will introduce the drug at a 'very healthy price,' although specific pricing details were not disclosed; initial prices are expected to be higher but may decrease as competition increases.
- Regulatory Approval Progress: Despite an initial rejection last year, Canada's drug regulator approved Dr. Reddy's marketing application for Ozempic in late April, making it the first generic approved in a G7 nation.
- Intensifying Market Competition: With Apotex also receiving approval for Ozempic and planning to launch by the end of May, more competitors are expected to enter the market, likely putting pressure on Novo Nordisk's market share.
See More
Major Earnings Reports Expected Before Tuesday: JD, SE, and More
- Earnings Release Preview: Major companies including JD.com, Sea Limited, and D-Wave Quantum are set to report earnings before the market opens on Tuesday, with investors keenly awaiting insights into their performance and future growth guidance.
- Market Reaction Anticipation: There is heightened interest in the earnings reports from JD.com and Sea Limited, as their performance in e-commerce and digital entertainment could significantly influence overall market sentiment.
- Additional Earnings Reports: In addition to JD and Sea, other companies such as Under Armour and Lithium Argentina are also scheduled to release earnings on the same day, expected to provide further industry dynamics and trend analysis for investors.
- Earnings Season Kickoff: The start of this week’s earnings season signals that investors will closely monitor the performance of major companies to assess the strength of economic recovery and industry outlook.
See More
Dr. Reddy's First to Receive Marketing Authorization for Generic Semaglutide Injection in Canada
- Market Authorization Milestone: Dr. Reddy's has received marketing authorization from Health Canada, becoming the first company to obtain approval for generic Semaglutide Injection, covering 2mg/pen and 4mg/pen, which underscores its leadership in the complex generics sector.
- Diabetes Patient Demand: According to the Public Health Agency of Canada, approximately 3.9 million people (9.7% of the population) are diagnosed with diabetes, and as the population ages, the number of diabetes patients is expected to continue rising, providing significant market potential for Dr. Reddy's products.
- In-House Production Capability: Dr. Reddy's active pharmaceutical ingredient (API) is entirely produced in-house, ensuring product quality and supply reliability, while partnering with OneSource Specialty Pharma Limited for finished product manufacturing, further enhancing the company's competitive edge in the market.
- Strategic Market Positioning: Being the first to receive market authorization not only boosts Dr. Reddy's brand influence in Canada but also demonstrates its product development capabilities under stringent global regulatory standards, which is expected to lay a foundation for long-term growth in the diabetes management sector.
See More
Dr. Reddy's Laboratories Seeks FDA Approval for Orencia Biosimilar
- FDA Review Application: Dr. Reddy's Laboratories has received FDA acceptance for its biosimilar DRL_AB, which, if approved, will be available as an intravenous infusion for rheumatoid arthritis and psoriatic arthritis patients, marking a significant advancement in the company's biopharmaceutical endeavors.
- Market Potential: Orencia generated $2.7 billion in revenue for Bristol-Myers Squibb in 2025, reflecting a ~1% year-over-year decline, yet demonstrating robust market demand; Dr. Reddy's biosimilar could directly compete in this lucrative market if approved.
- First Applicant: The company submitted its 351(k) Biologics License Application in December, becoming the first to seek U.S. approval for an off-patent version of Orencia, showcasing its pioneering position in the biosimilar sector.
- Interchangeability Goal: Dr. Reddy's aims for DRL_AB to achieve interchangeable status, which, if granted, would allow the drug to be substituted at the pharmacy level without the need for the prescribing healthcare provider's intervention, simplifying the medication process for patients and enhancing market acceptance and competitiveness.
See More
Dr. Reddy's Submits Biosimilar Application for Review
- Biosimilar Application: Dr. Reddy's Laboratories has had its 351(k) Biologics License Application (BLA) accepted for review by the US FDA, marking a significant milestone in the biosimilar sector and expected to provide cost-effective treatment options for patients.
- Broad Treatment Indications: DRL_AB, as a proposed biosimilar to ORENCIA® (abatacept), targets treatment for moderately-to-severely active rheumatoid arthritis, active psoriatic arthritis, and polyarticular juvenile idiopathic arthritis in patients aged six and above, addressing urgent market needs for effective therapies.
- Comprehensive Data Package: The BLA submission includes a robust data package comprising analytical, pharmacokinetic, and clinical studies, showcasing Dr. Reddy's strong capabilities in biologics development and enhancing its competitive position in the market.
- Future Market Potential: The biosimilars business at Dr. Reddy's plays a crucial role in driving both near-term and long-term growth, with global expansion plans expected to significantly increase the company's market share in the biologics sector.
See More
Dr. Reddy's Q4 Earnings Miss Expectations
- Disappointing Earnings: Dr. Reddy's reported Q4 GAAP EPS of $0.03, falling short of expectations, with revenue of $801 million reflecting an 11.7% year-over-year decline, indicating significant profitability challenges ahead.
- Significant Revenue Shortfall: The revenue missed analyst expectations by $54.01 million, which could undermine investor confidence and negatively impact the company's future financial outlook.
- Drug Review Progress: Dr. Reddy's biosimilar is currently under FDA review, and despite facing challenges, successful approval could provide new revenue streams and enhance competitive positioning in the market.
- Rating Downgrade Impact: Immutep's downgrade following a late-stage trial setback for its lead drug may trigger a ripple effect across the biopharmaceutical sector, prompting Dr. Reddy's to remain vigilant regarding market dynamics as an industry player.
See More
Dr. Reddy's to Launch Generic Ozempic in Canada Soon
- First Generic Launch: Dr. Reddy's Laboratories is set to launch its generic version of Ozempic in Canada within the next few days, becoming the first company to sell this product in the country, marking the beginning of market competition.
- Pricing Strategy: CEO Erez Israeli stated that Dr. Reddy's will introduce the drug at a 'very healthy price,' although specific pricing details were not disclosed; initial prices are expected to be higher but may decrease as competition increases.
- Regulatory Approval Progress: Despite an initial rejection last year, Canada's drug regulator approved Dr. Reddy's marketing application for Ozempic in late April, making it the first generic approved in a G7 nation.
- Intensifying Market Competition: With Apotex also receiving approval for Ozempic and planning to launch by the end of May, more competitors are expected to enter the market, likely putting pressure on Novo Nordisk's market share.
See More
Major Earnings Reports Expected Before Tuesday: JD, SE, and More
- Earnings Release Preview: Major companies including JD.com, Sea Limited, and D-Wave Quantum are set to report earnings before the market opens on Tuesday, with investors keenly awaiting insights into their performance and future growth guidance.
- Market Reaction Anticipation: There is heightened interest in the earnings reports from JD.com and Sea Limited, as their performance in e-commerce and digital entertainment could significantly influence overall market sentiment.
- Additional Earnings Reports: In addition to JD and Sea, other companies such as Under Armour and Lithium Argentina are also scheduled to release earnings on the same day, expected to provide further industry dynamics and trend analysis for investors.
- Earnings Season Kickoff: The start of this week’s earnings season signals that investors will closely monitor the performance of major companies to assess the strength of economic recovery and industry outlook.
See More
Dr. Reddy's First to Receive Marketing Authorization for Generic Semaglutide Injection in Canada
- Market Authorization Milestone: Dr. Reddy's has received marketing authorization from Health Canada, becoming the first company to obtain approval for generic Semaglutide Injection, covering 2mg/pen and 4mg/pen, which underscores its leadership in the complex generics sector.
- Diabetes Patient Demand: According to the Public Health Agency of Canada, approximately 3.9 million people (9.7% of the population) are diagnosed with diabetes, and as the population ages, the number of diabetes patients is expected to continue rising, providing significant market potential for Dr. Reddy's products.
- In-House Production Capability: Dr. Reddy's active pharmaceutical ingredient (API) is entirely produced in-house, ensuring product quality and supply reliability, while partnering with OneSource Specialty Pharma Limited for finished product manufacturing, further enhancing the company's competitive edge in the market.
- Strategic Market Positioning: Being the first to receive market authorization not only boosts Dr. Reddy's brand influence in Canada but also demonstrates its product development capabilities under stringent global regulatory standards, which is expected to lay a foundation for long-term growth in the diabetes management sector.
See More
Dr. Reddy's Laboratories Seeks FDA Approval for Orencia Biosimilar
- FDA Review Application: Dr. Reddy's Laboratories has received FDA acceptance for its biosimilar DRL_AB, which, if approved, will be available as an intravenous infusion for rheumatoid arthritis and psoriatic arthritis patients, marking a significant advancement in the company's biopharmaceutical endeavors.
- Market Potential: Orencia generated $2.7 billion in revenue for Bristol-Myers Squibb in 2025, reflecting a ~1% year-over-year decline, yet demonstrating robust market demand; Dr. Reddy's biosimilar could directly compete in this lucrative market if approved.
- First Applicant: The company submitted its 351(k) Biologics License Application in December, becoming the first to seek U.S. approval for an off-patent version of Orencia, showcasing its pioneering position in the biosimilar sector.
- Interchangeability Goal: Dr. Reddy's aims for DRL_AB to achieve interchangeable status, which, if granted, would allow the drug to be substituted at the pharmacy level without the need for the prescribing healthcare provider's intervention, simplifying the medication process for patients and enhancing market acceptance and competitiveness.
See More
Dr. Reddy's Submits Biosimilar Application for Review
- Biosimilar Application: Dr. Reddy's Laboratories has had its 351(k) Biologics License Application (BLA) accepted for review by the US FDA, marking a significant milestone in the biosimilar sector and expected to provide cost-effective treatment options for patients.
- Broad Treatment Indications: DRL_AB, as a proposed biosimilar to ORENCIA® (abatacept), targets treatment for moderately-to-severely active rheumatoid arthritis, active psoriatic arthritis, and polyarticular juvenile idiopathic arthritis in patients aged six and above, addressing urgent market needs for effective therapies.
- Comprehensive Data Package: The BLA submission includes a robust data package comprising analytical, pharmacokinetic, and clinical studies, showcasing Dr. Reddy's strong capabilities in biologics development and enhancing its competitive position in the market.
- Future Market Potential: The biosimilars business at Dr. Reddy's plays a crucial role in driving both near-term and long-term growth, with global expansion plans expected to significantly increase the company's market share in the biologics sector.
See More
