Indian Court Allows Dr. Reddy's to Produce Generic Versions of Novo Nordisk's Blockbuster Drugs — 2nd Update

By Dominic Chopping

An Indian court allowed Dr. Reddy's Laboratories to manufacture and export generic versions of Novo Nordisk's blockbuster diabetes and weight-loss drugs.

In a Dec. 2 decision, the Delhi High Court dismissed Novo Nordisk's application to block production of semaglutide--the key ingredient in Ozempic and Wegovy--allowing the Indian drugmaker to make the drug and export it to countries where it doesn't have patent protection.

The decision comes as the patent for semaglutide is due to expire in India early next year.

According to court documents, Dr. Reddy's confirmed that it wouldn't sell the drug in India until the patent expires next March, and the court ordered the company to keep a record of the quantity and value of the products its manufactures and sells.

Dr. Reddy's began producing the drug in April this year, according to the documents.

Patent protections for semaglutide expire in India, Canada, Brazil and China next year, clearing the way for cheaper generic versions to be sold in those markets. In Europe, the U.S. and Japan, patents aren't due to expire until the 2030s.

Novo Nordisk has the option to appeal to the Supreme Court.

A spokesperson for the Danish company said they have received a copy of the judgment and are currently examining it.

Dr. Reddy's didn't respond to a request for comment.

Write to Dominic Chopping at dominic.chopping@wsj.com

By Dominic Chopping

An Indian court allowed Dr. Reddy's Laboratories to manufacture and export generic versions of Novo Nordisk's blockbuster diabetes and weight-loss drugs.

In a Dec. 2 decision, the Delhi High Court dismissed Novo Nordisk's application to block production of semaglutide--the key ingredient in Ozempic and Wegovy--allowing the Indian drugmaker to make the drug and export it to countries where it doesn't have patent protection.

The decision comes as the patent for semaglutide is due to expire in India early next year.

According to court documents, Dr. Reddy's confirmed that it wouldn't sell the drug in India until the patent expires next March, and the court ordered the company to keep a record of the quantity and value of the products its manufactures and sells.

Dr. Reddy's began producing the drug in April this year, according to the documents.

Patent protections for semaglutide expire in India, Canada, Brazil and China next year, clearing the way for cheaper generic versions to be sold in those markets. In Europe, the U.S. and Japan, patents aren't due to expire until the 2030s.

Novo Nordisk has the option to appeal to the Supreme Court.

Novo Nordisk and Dr. Reddy's didn't respond to requests for comment.

Write to Dominic Chopping at dominic.chopping@wsj.com

The equity benchmarks gave up gains in a highly volatile session on Thursday as profit-booking pulled the indices off their intraday highs. The Sensex slipped about 250 points from its peak, while the Nifty fell below 26,050 during the session.

The Sensex opened on a weak note, declining 156.83 points to 84,949.98. The Nifty too eased 47 points to 25,938.95. Both indices later recouped losses, with the Sensex trading 369.80 points higher at 85,476.62 and the Nifty at 26,096.25, up 110.25 points.

InterGlobe Aviation, Dr. Reddy's Laboratories and Kotak Mahindra Bank were among the major laggards in the Nifty50 pack, declining up to 2 percent, while Tata Consultancy Services and Tech Mahindra Limited were the top gainers, rising up to 2 percent. Market breadth remained negative as about 1765 shares advanced, 1848 shares declined and 151 shares unchanged.

Key factors behind market decline

1) Rupee under pressure: The rupee fell 28 paise to a fresh low of 90.43 against the US dollar in early trade. A weakening currency typically dampens market sentiment as it prompt foreign investors to turn cautious.

2) Sustained FII selling: Foreign Institutional Investors offloaded equities worth Rs 3,206.92 crore on Wednesday, marking the fifth straight session of outflows. Persistent selling by overseas investors has continued to put pressure on domestic equities.

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3) Caution ahead of RBI policy: The Reserve Bank of India’s Monetary Policy Committee will announce its policy decision on Friday. With growth staying strong and the rupee weakening, investors are unsure whether the central bank will signal any shift in its stance.

"Investors are focused on the RBI’s policy call and tone," Kranthi Bathini, Director of Equity Strategy at Wealthmills Securities told Reuters.

Adding to the cautious mood, Prashanth Tapse, Senior VP (Research) at Mehta Equities Ltd, said "Nifty slipped below the 26,000 mark yesterday, extending its losing streak to a fourth straight session with market breadth firmly favouring the bears. A sliding rupee and persistent FII outflows continue to weigh on sentiment, while upcoming RBI and Fed policy decisions and geopolitical developments could add fresh volatility."

4) Weekly expiry: Volatility picked up as traders squared off positions on the weekly derivatives expiry, leading to frequent swings between positive and negative territory.

5) Firm crude prices: Brent crude rose 0.35 percent to USD 62.89 per barrel. Higher crude prices tend to unsettle domestic markets as they can push up import costs and impact inflation expectations.

Technical view

Anand James, Chief Market Strategist at Geojit Financial Services, said the Nifty’s attempt to recover appeared to have paused near the 26,000 mark. "A phase of consolidation may be required before a move towards 26,111 or a break above 26,200,” he said. “However, a fall below 25,935 could confirm a resumption of the downside."

Disclaimer: The views and investment tips expressed by experts on Moneycontrol are their own and not those of the website or its management. Moneycontrol advises users to check with certified experts before taking any investment decisions.

The Delhi High Court has allowed Dr Reddy’s Laboratories Ltd to manufacture its version of diabetes and anti-obesity drug semaglutide in India for export even as Danish firm Novo Nordisk pursues a patent infringement case.

The company, however, will not be allowed to sell the drug in the country till March 2026, when Novo Nordisk’s secondary patent expires.

On December 2, Justice Manmeet Pritam Singh Arora ruled that Dr Reddy’s can continue production under the Bolar exemption, citing a “credible challenge” to the validity of Novo Nordisk’s patent for semaglutide, marketed globally as Wegovy.

The court said exports may proceed uninterrupted, but any commercial activity in India is prohibited until the end of the patent term.

The Bolar exemption refers to a legal defence against patent infringement. It allows manufacturers of generics to use a patented drug to conduct studies, develop generic versions, and apply for regulatory approval. It ensures that a generic version can be launched quickly once the patent ends.

Novo Nordisk has alleged infringement, claiming that Dr Reddy’s imported active pharmaceutical ingredients and manufactured finished formulations without consent.

The Indian firm argued that the patent was invalid and amounted to evergreening, saying its production was solely for export to markets where Novo Nordisk’s rights had lapsed.

The dispute underscores the stakes in India’s fast-growing diabetes market, where nearly 90 million adults live with type-2 diabetes and another 25 million are prediabetic, according to WHO.

Dr. Reddy’s began producing semaglutide in April after securing regulatory approval in December 2024. Novo Nordisk responded with a cease-and-desist notice and filed an infringement suit in May. The case continues, with final outcome on patent validity and statutory exemptions pending further hearings.

As the patent for semaglutide will expire in March, India companies are lining up to launch generics, which will widen access to these drugs.

Medicare has negotiated steep new prices for 15 high-cost drugs, including Novo Nordisk’s blockbuster semaglutide (Wegovy and Ozempic), with negotiated prices set to take effect in 2027.

The move cuts projected Medicare spending by an estimated $8.5 billion to $12 billion annually and forces drugmakers to reassess pricing, access, and strategy on the world’s largest market.

The announcement arrives at a delicate political moment, reflecting both Biden-era policy continuity and Trump administration negotiating tactics that have reshaped pharmaceutical pricing expectations.​

This matters because the new price structure could reshape business models across European pharma.

Novo Nordisk, AstraZeneca, GSK, and Boehringer Ingelheim face pricing pressure that ripples beyond the US, forcing them to recalibrate global strategies and prepare for tougher negotiations worldwide.​

Policy & market snapshot: the numbers and immediate reactions

Medicare will pay $274 monthly for semaglutide (sold as Ozempic for diabetes and Rybelsus), down from a 2024 list price of $959, a 71% reduction representing the steepest discount in the negotiation round.

Wegovy for weight loss will cost $386 monthly, also down 71% from the list.

The 15-drug package spans cancer, respiratory, and metabolic conditions, with discounts ranging from 38% to 85% off published list prices.

The CMS estimates total Medicare Part D enrollment savings of roughly $685 million once prices take effect in 2027, though the full budget impact depends on volume and the interaction with prior separate most-favored-nation deals announced by the Trump administration.​

Market reaction was muted: Novo Nordisk shares rose 4.8% on the news, with analysts noting the hit was “largely anticipated” and prior guidance already factored in a low-single-digit global sales impact of roughly 6 billion Danish crowns ($900 million) if cuts were implemented immediately.

Peers fared similarly, with AstraZeneca and GSK each trading flat, as Shore Capital’s Sean Conroy noted that “cuts are already reflected in company guidance”.

Novo said in a statement: “We continue to have serious concerns about the Inflation Reduction Act’s impact on innovation,” warning of potential coverage losses and higher premiums, though the company accepted the deal.​

Analytical take: revenue trade-offs and strategic responses

The real test for Novo Nordisk and European pharma is whether higher patient access and volume can offset margin compression.

JPMorgan analysts said the impact was “already captured in Novo’s forecast,” implying limited surprise to earnings.

However, the devil lies in execution: semaglutide is Novo’s revenue engine, the drug alone generated over $14 billion in gross Medicare costs in the past year, so even modest volume gains would need to offset significant per-unit margin loss.​

Strategic responses are already emerging. Novo Nordisk has cut direct-to-consumer prices to $349 monthly for Wegovy and Ozempic, unlocking uninsured and high-deductible patients outside Medicare.

The company is also accelerating pipeline launches: oral Wegovy (2026) and CagriSema (a combination therapy) could diversify revenue and restore growth if market adoption accelerates.

For GSK and AstraZeneca, the pressure is narrower; their drugs represent smaller revenue streams, but both are preparing for similar payer pressure in Europe and Asia, where tender systems and health-technology-assessment bodies now cite Medicare’s rates as benchmarks for negotiation.​

The broader structural risk is that negotiated Medicare prices reset payer expectations globally.

Boehringer Ingelheim noted that over 80% of its US business is now subject to government-negotiated prices; the firm warned that this “siphons billions from research and development”.

Yet, industry opposition has not slowed the program. The third round of Medicare negotiations begins in February 2026, with expectations that another 15 drugs will be selected.​

The real question: can Novo Nordisk and European peers convert lower prices into market expansion, or will unit economics and competitive pressure force cost-cutting and slower innovation?

Investors will be watching guidance updates, EU regulator reactions, and early Medicare uptake data when it arrives in 2027.https://www.cityam.com/budget-obr-leak-labour-rachel-reeves/

Novo Nordisk could benefit from higher volumes as the obesity market evolves, but it will likely take time for investors to give credit, Goldman Sachs analysts write. Pricing across the obesity portfolio will be a headwind, but volumes may offer a partial offset, as well as the launch of oral Wegovy, they say. Expectations have reset sharply downwards, but Goldman Sachs still sees opportunities for Wegovy, CagriSema and oral Wegovy to drive value in excess of what the market currently believes. The bank adjusts estimates to reflect recent newsflow. It cuts its 2026 revenue and EBIT estimates by around 5% and 8%, respectively, and reduces its 2027-2030 revenue and EBIT estimates by 4% to 5%. It lowers its target price on the stock to 353 Danish kroner from 391 kroner and keeps at buy. Shares trade 3.8% higher at 311.30 kroner. (dominic.chopping@wsj.com)