Dr Reddy’s semaglutide approvals: tablets, Obeda in 2026

Why semaglutide approvals are in focus

Dr Reddy’s Laboratories has moved deeper into India’s fast-growing GLP-1 therapy space with two distinct regulatory and commercial milestones around semaglutide. The company confirmed final approval from the Central Drugs Standard Control Organisation (CDSCO) to manufacture and sell generic versions of semaglutide tablets, while also launching its injectable semaglutide under the brand name Obeda after approval from the Drugs Controller General of India (DCGI). The developments come as innovator Novo Nordisk continues to dispute alleged patent infringement by Indian drugmakers.

Semaglutide is the active ingredient behind Novo Nordisk’s diabetes and anti-obesity drugs, including Ozempic and Wegovy, and it is also sold as an oral tablet under the Rybelsus brand. In India, the patent landscape is fragmented by dosage form, which is shaping how and when generic players can enter each segment.

CDSCO clears Dr Reddy’s generic semaglutide tablets

Dr Reddy’s said it received final CDSCO approval to manufacture and sell generic semaglutide tablets in India. The company did not disclose a launch timeline. The approval was supported by a head-to-head comparative study conducted in India, which the company said established non-inferiority versus Novo Nordisk’s oral semaglutide (Rybelsus).

A company spokesperson said the product was approved under the biosimilar regulatory pathway, based on the clinical evidence generated locally. Dr Reddy’s also noted that an expert committee had earlier provided a positive opinion on its application based on data from local clinical trials.

Oral semaglutide: strengths, SNAC and the regulator’s note

According to a regulator’s note cited in the report, Dr Reddy’s has received approval for three oral compositions of semaglutide tablets: 3 mg, 7 mg and 14 mg. The tablets are indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus.

Dr Reddy’s also addressed formulation specifics involving SNAC, an absorption enhancer used in oral semaglutide. The report cited Novo’s claimed molar range as 0.65-2.1 mmol per tablet. Dr Reddy’s said it independently developed its oral semaglutide formulation by incorporating SNAC within a defined and optimized concentration range.

Patents: core semaglutide expiry vs oral formulation protection till 2031

The report said the core semaglutide patent expired in India last month. But it also highlighted that Novo Nordisk’s patent on oral formulations runs until 2031. Novo sells oral semaglutide under the Rybelsus brand.

This split between molecule-level protection and formulation-level protection is central to the dispute playing out in India. It also explains why market entries can differ across tablets and injections, and why companies may face legal or regulatory scrutiny even after a core patent expires.

Obeda launch: DCGI-approved generic semaglutide injection

Separately, Dr Reddy’s launched Obeda, described as India’s first DCGI-approved generic semaglutide injection for type 2 diabetes. The company said it marked a Day-1 entry after patent expiry. Obeda is offered in 2 mg and 4 mg strengths in pre-filled, disposable pens for once-weekly subcutaneous administration, and the company said robust cold-chain integrity is maintained through distribution.

Each pen delivers a minimum of four weekly doses. Dr Reddy’s said Obeda is prescription-based and positioned the launch as a step toward expanding access to GLP-1 receptor agonist-based therapy in India.

Clinical evidence cited for Obeda and for tablets

For Obeda, the company cited a head-to-head Phase III clinical study enrolling 312 participants. It said Obeda demonstrated non-inferior efficacy and a comparable safety profile versus the innovator drug, with similar glycaemic reduction. It also reported comparable outcomes for fasting glucose control, post-prandial glucose control, and achieving HbA1c below 7.0% at study end, and said no anti-drug antibodies were detected and immunogenicity was comparable.

For the oral semaglutide tablets, Dr Reddy’s said the formulation was clinically evaluated in a head-to-head comparative study conducted in India and was found non-inferior to Novo Nordisk’s oral semaglutide (Rybelsus), supporting approval through the biosimilar pathway.

Pricing and market context: ₹4,200 per month and GLP-1 competition

Dr Reddy’s priced Obeda at ₹4,200 per month for both the 2 mg and 4 mg strengths. The report also described this as a 62% drop from the highest dosage form of the innovator drug Ozempic marketed by Novo Nordisk.

Broader competition intensified after semaglutide lost patent protection in India. The report said at least six domestic companies launched generic semaglutide on Day 1, including Dr Reddy’s Laboratories, Sun Pharma, Glenmark Pharmaceuticals, Alkem Laboratories, Zydus Lifesciences, and Natco Pharma. Their prices were reported to range from ₹1,300 to ₹4,200 per month, compared with the innovator brands priced at ₹8,800 and ₹10,850 per month for starting doses.

The company is targeting India’s ₹1,446 crore GLP-1 market, as cited in the report.

What the approvals mean for patients and prescribing

Both the tablet approval and the Obeda launch are framed around type 2 diabetes management. The oral tablets are indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus. Obeda is a once-weekly injectable option, delivered via a pre-filled pen device.

Dr Reddy’s also linked the launch to patient support through the SemaKare patient-support program, and said it plans broader GLP-1 portfolios and metabolic centres of excellence in India. The report cited the diabetes burden as more than 101 million adults living with diabetes in the country.

Key facts at a glance

Market impact: pricing pressure and form-factor segmentation

The immediate market impact highlighted in the report is pricing compression as multiple Indian companies enter after patent expiry, with monthly therapy prices reported between ₹1,300 and ₹4,200. For Novo Nordisk, the reported innovator pricing for starting doses at ₹8,800 and ₹10,850 per month sets a wide gap that generics are targeting.

The second factor is segmentation by formulation. Oral semaglutide has distinct intellectual property constraints compared with injectable semaglutide, and the report underscored that Novo Nordisk’s oral formulation patent runs until 2031 even though the core patent expired last month. That framework can influence launch timelines, legal strategies, and how quickly competition scales across dosage forms.

Analysis: why the tablet approval and Obeda launch matter

Dr Reddy’s is building presence across both injectable and oral GLP-1 therapies, supported by head-to-head clinical comparisons reported for each product line. In a market where affordability is a central barrier, the ₹4,200 per month pricing for Obeda becomes a reference point as more companies compete in the same therapeutic class.

At the same time, the report shows that generics in complex drugs may hinge as much on formulation science and regulatory pathways as on patent expiry dates. The mention of SNAC concentration ranges and the use of a biosimilar regulatory pathway for oral semaglutide indicate that technical and regulatory positioning will be closely examined alongside legal arguments around patent claims.

What to watch next

Dr Reddy’s did not provide a launch timeline for its generic semaglutide tablets despite confirming CDSCO’s final approval. The report also said the company is separately seeking regulatory approval to market semaglutide for weight management.

For investors and industry watchers, the next set of signals will likely be the company’s stated commercial rollout plans for oral tablets, further regulatory updates related to weight management, and any developments in Novo Nordisk’s disputes with Indian drugmakers over alleged patent infringement.