Semaglutide Ruling Sparks Generic Pharma Boom

At the heart of this debate is Section 3(d) of the Patents Act, a safeguard designed to prevent drugmakers from extending monopoly protection through trivial modifications to existing medicines.

The recent ruling by the Delhi high court allowing Dr Reddy's Laboratories to continue manufacturing diabetes and weight-management drug semaglutide in India opens up opportunities worth billion of dollars for domestic generic drugmakers.

Sales and exports have, for now, been allowed only to those jurisdictions where Danish drugmaker Novo Nordisk, which holds the patent for semaglutide, does not have patent protection.

Semaglutide patent expiry impact

In India and Canada, Novo Nordisk's patent on semaglutide, the active ingredient in blockbuster brands such as Rybelsus, Ozempic, and Wegovy, expired on March 20.

All of these brands are marketed as the next wonder in weight loss management.

The weight-loss market in India stands at around Rs 1,446 crore on a moving annual turnover (MAT) basis, with semaglutide-based drugs accounting for Rs 445 crore as of February 2026.

Blockbuster drugs nearing patent expiry

Apart from semaglutide, several other blockbuster drugs are approaching patent expiry in India by 2026.

These include sacubitril/valsartan (Vymada) and several biologic oncology drugs.

India's revocation of Novartis' patent for its heart drug Vymada last year has already paved the way for generic competition.

India battle against evergreening

Long-running battle

This and other similar rulings have also brought back into focus India's long-running battle against 'evergreening', the practice by pharma companies to try and torpedo the expiry of a patent by claiming 'improvements' or changes to the original formulations.

At the heart of this debate is Section 3(d) of the Patents Act, a safeguard designed to prevent drugmakers from extending monopoly protection through trivial modifications to existing medicines.

In the last few years, Indian courts have heard a series of cases involving blockbuster molecules such as semaglutide, risdiplam and nivolumab.

Most of the court's decisions have either cleared the way for generics or challenged the validity of patents held by multinational (MNC) pharmaceutical companies.

Key court rulings on generics

In October 2025, the Delhi high court allowed Hyderabad-based Natco Pharma to launch its version of Roche's spinal muscular atrophy (SMA) therapy Risdiplam despite opposition from the latter.

Natco had then said that it would price its version at Rs 15,900 per bottle, compared with Rs 6.2 lakh per bottle charged by Roche under the brand Evrysdi.

The Supreme Court also later dismissed Roche's challenge, effectively clearing the way for the generic version to enter the market.

In another recent ruling, the Delhi high court allowed Zydus to proceed with the manufacturing and sale of American multinational Bristol Myers Squibb (BMS)'s immunotherapy drug Nivolumab, marketed as Opdivo and as Opdyta in India.

Treatment costs, therefore, increase by Rs 2 lakh to Rs 3.5 lakh per month.

In its ruling, the court held that access to affordable treatment could not be denied to patients, while turning down BMS' plea to block Indian companies from producing biosimilar versions of Nivolumab.

Following the ruling, Ahmedabad-based Zydus Lifesciences launched Tishtha, its version of Nivolumab, and priced it at Rs 13,950 and Rs 28,950 for the two dosage forms.

Patent litigation wave in 2026

Legal and industry experts believe 2026 could be a crucial year, as a fresh wave of disputes over secondary patents covering formulations, dosages, and minor modifications could emerge.

There could be intensified litigation as generic manufacturers challenge follow-on patents intended to prolong exclusivity, the experts said.

"Incremental pharmaceutical changes now need to show a substantial clinical benefit in order to get past the evergreening barrier," said Ankit Rajgarhia, designate partner at Bahuguna Law Associates.

The decisions emerging from this phase will likely crystallise the evidentiary standards for therapeutic efficacy and shape enforcement strategies for the next decade," Rajgarhia added.

Most legal experts also believe that Indian courts have become increasingly exacting in applying Section 3(d).

After testing for novelty and non-obviousness, judges apply the Section 3(d) filter to ensure incremental changes demonstrate enhanced therapeutic efficacy.

Courts also weigh broader public-interest considerations when deciding interim relief in patent disputes, Rajgarhia said.

The test most courts apply to avoid patent evergreening is whether small changes in dosage, polymorph, or formulation demonstrate enhanced therapeutic efficacy, said Rahul Hingmire, managing partner at Vis Legis Law Practice.

"In oppositions and revocation matters, judges now expect solid clinical data, not theoretical claims," Hingmire said.

Industry analysts say this combination of expiring patents and stricter scrutiny is likely to accelerate generic entry in India over the next two years.

While the legal framework is designed to curb evergreening, litigation tactics can still delay generic entry as even relatively weak secondary patents can temporarily block competition through interim injunctions, experts said.

"In infringement suits before the High Court, originators often seek ad-interim relief pending trial.

Even a six-to-twelve-month delay can significantly affect market access," Hingmire said.

Section 3(d) and patent challenges

'Questionable patents'

Despite the risks and challenges, court rulings continue to strengthen generic companies to challenge questionable patents, the experts said.

A recent Delhi high court ruling held that a revocation challenge under Section 64 of the Patents Act can continue even after the patent has expired, particularly where damages are claimed in an infringement suit.

A revocation challenge under patent law is a legal proceeding to challenge the validity of a granted patent, often initiated by third parties or the government for reasons such as lack of novelty, obviousness, or improper disclosure.

If the patent is eventually revoked by a court ruling, the invalidation operates retrospectively, treating the patent as void from the date of grant.

Swati Sharma, partner and head of intellectual property at Cyril Amarchand Mangaldas, said the decision primarily clarifies procedural strategy rather than dramatically altering litigation risks for patent holders.

"Defendants would generally always defend any patent infringement claim by filing a revocation petition or counter-claim," Sharma said.

"The decision clarifies that such challenges can continue even after the patent expires."

Despite periodic international pressure for stronger intellectual property protections through trade negotiations, experts say India's anti-evergreening framework remains firmly entrenched.

Hingmire said Section 3(d) is now embedded in Indian patent jurisprudence and continues to shape how courts approach pharmaceutical innovation and access to medicines.

"In practice, India's legal framework balances innovation and access," he said.

"It is unlikely to dilute core public health protections."

As pharmaceutical companies prepare for a new cycle of patent expiries and follow-on filings, the outcomes of litigation in 2026 and in the coming years could determine how effectively India continues to police evergreening while still protecting genuine pharmaceutical innovation.

Delhi high court rulings

Semaglutide (2026)

• The court allowed Dr Reddy's Laboratories to manufacture semaglutide in India but restricted sales and exports

Risdiplam (2025)

• It permitted Natco Pharma to launch a generic version of Roche's spinal muscular atrophy drug

Nivolumab (2025)

• Zydus Lifesciences allowed to manufacture and sell biosimilar versions of Bristol Myers Squibb's cancer immunotherapy drug

Pricing has emerged as a key battleground

About 10 Indian pharmaceutical companies have launched branded generic versions of semaglutide -- the active ingredient in blockbuster weight-loss and diabetes drugs Ozempic and Wegovy -- following the expiry of the innovator's patent on March 20.

Nomura Research expects the market, currently pegged at Rs 1,600 crore, to expand into a Rs 12,000 crore opportunity over the next five years.

Semaglutide Patent Expiry India

Companies including Dr Reddy's Laboratories (DRL), Sun Pharmaceutical Industries, Zydus Lifesciences, Natco Pharma, Alkem Laboratories, and Torrent Pharmaceuticals have developed their own formulations.

Others, such as Glenmark Pharmaceuticals, Eris Lifesciences, Lupin, and USV, have entered the market through in-licensing agreements.

50+ Generic Brands Launch

More than 50 generic brands of semaglutide are expected to launch in India across three dosage forms: Disposable pens, reusable pens, and oral tablets, ICICI Securities notes.

Among the products developed in-house, Zydus, Alkem, and Sun Pharma have received approvals for both Type 2 diabetes and obesity indications, expanding their addressable market.

DRL and Natco have approvals for diabetes only.

Pricing War Among Pharma Firms

On the licensing front, DRL has licensed its product to USV and Torrent, while Zydus has licensed its differentiated reusable pen to Lupin and Torrent.

Natco has licensed its vial and disposable pen formulations to Glenmark and Eris.

A few companies have introduced differentiated delivery devices.

Zydus and Alkem have introduced reusable pens, offering a more cost-effective alternative to disposable formats.

Zydus' pen also allows dose adjustments, particularly useful during the initial titration phase.

The firm has secured an exclusive agreement with its pen supplier to protect this advantage.

Pricing has emerged as a key battleground, with Alkem standing out for its aggressive strategy.

Most companies have priced the disposable pen at Rs 4,200–5,200 per month for diabetes treatment, while Alkem has priced its disposable pen at roughly Rs 2,000 per month -- less than half the market rate.

For obesity, Sun Pharma's maintenance dose is around Rs 8,000 per month, compared with roughly Rs 3,500 for Alkem.

Oral Semaglutide Market Push

Torrent has emerged as the first mover in the oral segment.

It is the only listed company, according to ICICI Securities, to announce an oral product (a generic version of Rybelsus) across all three dosages.

Analysts expect DRL and Sun Pharma to follow soon.

Natco, along with partners Glenmark and Eris, has taken a different approach by introducing low-cost vials, targeting price-sensitive patients and institutional buyers.

Rs 12,000 Crore Market Opportunity

According to Macquarie Research, Torrent, Sun Pharma, Lupin, and Eris are best positioned for market-share gains -- Torrent (oral), Sun Pharma (portfolio/device), Lupin (Zydus partnership), and Eris (vial pricing plus upcoming pens) -- with larger players leveraging scale for distribution and innovation.

Reusable pens from Zydus and Alkem offer the best combination of pricing and convenience, with monthly costs ranging from Rs 1,800–2,200 for diabetes and Rs 3,500–5,500 for obesity.

The vial format is the cheapest, at about Rs 1,290 per month for diabetes.

Nomura Research expects the Indian semaglutide market to exceed Rs 12,000 crore over the next five years.

Initial pricing is broadly in line with analyst estimates, with further reductions and volume growth expected.

Zydus is seen as a key beneficiary, given its differentiated product and licensing tieups with players strong in the diabetes segment.

Alkem, despite a relatively weaker diabetes foothold, could gain above-average volume share through aggressive pricing and the reusable pen launch.

DRL, via partnerships with USV and Torrent, and Sun Pharma, backed by its large commercial infrastructure, are also expected to capture above-average market share.

Analysts, however, caution on the oral segment, observing that sales of Rybelsus -- the innovator's oral version -- have declined recently.

In the vial segment, analysts expect volume share to remain below 30 per cent, given the preference for pen-based delivery.

Macquarie Research expects six to 12 months of consolidation, with price wars over volume gains followed by sustained expansion.

Investors will monitor risks including supply-chain issues, regulatory scrutiny on bioequivalence, and potential innovator pushback, which could have stock implications for listed players.

Feature Presentation: Ashish Narsale/Rediff

Feature Presentation: Ashish Narsale/Rediff