Pharma Opportunities Ahead: Key Drugs Going Off-Patent in India (2025-2027)

Explore high-impact opportunities as branded and blockbuster drugs lose patent protection in India between 2025-2027. Gain insights into market potential, regulatory pathways, and how to position your portfolio for first-mover advantage.

1. Introduction 

In the pharmaceutical industry, every drug comes with a specific expiry date, not only on labels but also on the market exclusivity. When a drug goes off patent, it signifies the expiration of the legal protection that previously prevented other manufacturers from developing and marketing equivalent generics. Drug patents are typically granted for 20 years from the date of filing, providing innovator companies with exclusive rights to manufacture and sell the product. With the expiration of patents, any qualified manufacturer can apply to produce and market a generic equivalent, significantly reducing costs and enhancing patient access. 

For pharmaceutical companies operating in cost-effective, high-volume markets like India, monitoring patent expiration is a strategic imperative, not just due diligence. The expiration of branded and blockbuster drug patents creates significant opportunities. It allows new entrants into the market and opens doors to new therapeutic segments. Furthermore, it enables companies to capture substantial market share and expand exports by providing affordable alternatives worldwide. These patent expirations frequently lead to a surge of generic drug launches, thereby transforming the competitive landscape in both domestic and international markets.

As the world's largest supplier of generic medicine, providing approximately 20% of the global supply, India is uniquely positioned to capitalize on upcoming off-patent opportunities. Indian pharmaceutical companies, with their robust manufacturing base, proven regulatory experience, and cost-efficient R&D ecosystem, are well-equipped to serve the domestic population and lead the global push for affordable healthcare. The period from 2025 to 2027 will witness a significant wave of patent expirations, presenting substantial growth potential for companies that are agile in manufacturing, swift in action, and efficient in navigating regulatory pathways. At Walter Healthcare, we empower pharmaceutical companies to identify and capitalize on opportunities. We provide comprehensive CDMO support, from molecule scouting and formulation development to regulatory affairs and manufacturing scale-up, enabling our partners to operate with speed, compliance, and confidence. This post will delve into drugs nearing patent expiration, offering a comprehensive market analysis, identifying key opportunities, and outlining regulatory pathways as defined by NDCTR 2019.

2. List of Major Drugs Approaching Patent Expiry (2025-2027)

Although India does not maintain a public-facing centralized list, global patent expirations often closely mirror Indian timelines. Here's a curated list of key drugs anticipated to lose patent protection between 2025 and 2027. 

3. Market Impact & Opportunity Analysis

In India, some blockbuster products are set to go off patent in 2025, including Empagliflozin and Dapagliflozin (type 2 diabetes drugs), rivaroxaban (anticoagulant), aripiprazole (schizophrenia), tapentadol (pain), and asthma medications. For the year 2026, the patent for Semaglutide (active in Ozempic and Wegovy) will lapse, but the drug is due to enter the public domain, India by 2027.  These drugs represent several blockbuster molecules whose global branded revenue exceeds $100 billion, including Keytruda, Eliquis, etc., poised to enter generic or biosimilar markets by 2027–29. 

3.1 Estimate the market size or potential for these off-patent drugs

The India Generic Drugs Market size is estimated at USD 26.31 billion in 2025, and is expected to reach USD 35.40 billion by 2030, at a CAGR of 6.10% during the forecast period (2025-2030). Patent expirations worth USD 112 billion in global sales (2023–29) may unlock a USD 10 billion opportunity for Indian exporters/global generic players by 2029. This shift allows them to capture a substantial share of the market previously dominated by patented drugs.

Reference: The significant impact of patent expiration on pharmaceutical markets, particularly observed with Empagliflozin in India, highlights a critical dynamic. Upon its patent expiry on March 11, 2025, the dramatic 85–90% price reduction (from ₹60 to ₹5–9) for Empagliflozin underscores the immediate and substantial effect on domestic pricing. This price drop subsequently stimulated a rapid increase in sales volume, with leading brands experiencing a doubling of their sales within a single month.

This study is particularly relevant within the context of India's robust anti-diabetes market, which is currently valued at approximately ₹20,600 crore (~USD 2.5 billion) and demonstrates a consistent annual growth rate of around 9%. The anticipated 50-100% volume surge post-patent expirations, as evidenced by Empagliflozin, suggests a predictable market response. Even with potential unit price decreases, the long-term projection indicates that the overall market value is likely to surpass previous branded levels within a 2-3 year timeframe, indicating a sustained growth trajectory driven by increased accessibility and affordability.

3.2 Highlight why pharma companies should prioritize these products

• Portfolio Synergy and Therapeutic Depth

When drugs go off-patent, it creates opportunities for companies to expand their presence in rapidly growing therapeutic areas. This includes segments like diabetes (with drugs such as empagliflozin, dapagliflozin, and semaglutide), cardiovascular health (rivaroxaban), central nervous system disorders (aripiprazole), and pain management (tapentadol). Incorporating these molecules not only strengthens a company's product offerings but also facilitates integrated marketing efforts and improves relationships with physicians.

• Export and First-Mover Edge

Companies that enter post-patent markets early on secure pricing power, prescriber trust, and institutional contracts. Indian pharmaceutical companies can also leverage the global demand for generics, particularly in emerging markets and regulated regions such as the EU and Canada. Robust CDMO support enables companies to expedite filings and rapidly obtain export-ready, compliant dossiers.

• Market Expansion and Access

In India's price-sensitive market, drug patent expiry significantly reduces costs, opening up vast patient access. This is particularly true for chronic therapies like empagliflozin and semaglutide, where generic versions can quickly reach Tier 2 and 3 cities. The result is expanded patient access, improved public health, and higher sales volumes due to increased affordability and accessibility.

3.3 Insight into a competitive advantage for early movers

• Early Adopter Advantage Equals Highest Market Share

In India's cost-sensitive pharmaceutical market, the early entry of low-cost generics significantly impacts market share. The first generic entrants can capture a 40-60% market share before the increased competition, influencing future pricing for tenders and exports. Timely market entry is crucial for profitability as affordable early generics quickly displace branded drugs.

• Brand Recall & Channel Loyalty

Indian retail pharmacists and stockists, along with institutional buyers such as government tenders and hospital procurement departments, demonstrate a strong preference for generic brands that establish themselves early in the market. These early-performing generics are favored due to their attractive margins and rapid inventory turnover, securing them recurring business for years to come, especially through initial major hospital or public sector orders.

• Pricing Power Before Competition Lowers Margin

Gaining early access to the generic market offers a significant advantage due to initial premium pricing, which typically erodes as more generics enter the market within 6-12 months. This early entry also facilitates the creation of unique generic formulations, such as Fixed-Dose Combinations (FDCs) or alternative dosage forms, helping to build and sustain brand recognition. Moreover, under NDCTR, the first applicants submitting a waiver-eligible dossier (BCS Class I/III) can achieve rapid approval with minimal data, securing a vital head-start in the market.

• Strategic Leverage for Global Markets

India's significant role as a generics exporter to global markets like the US, EU, LATAM, and Africa means that early drug approval within the country can strategically position companies for accelerated ANDA filings or WHO-GMP dossier preparations for international markets. This domestic success not only bolsters global credibility but also leverages Indian NDCTR approval for parallel submissions to WHO-PQ or other ROW countries, often relying on CDSCO review reports.

4. Formulation and Manufacturing Considerations

For off-patent (generic) drugs, the main challenge is bioequivalence, which involves ensuring the generic drug functions the same way as the original innovator drug. This must be achieved without access to the proprietary formulation details of the original drug.

4.1 Key hurdles

• Formulation Complexity: It is challenging to accurately replicate an innovator's complex drug formulation, such as modified-release tablets, suspensions, or injectables, without precise knowledge of the specific excipient grades, their proportions, or the manufacturing processes employed. Even minor deviations in these aspects can significantly affect the drug's release profile, its absorption into the body, and its overall stability.

• Stability Challenges: It is challenging to achieve the original drug's shelf-life and stability. Issues can arise from excipient interactions, changes in the active pharmaceutical ingredient's crystalline structure, or packaging choices, all of which can lead to degradation, reduced potency, or altered dissolution characteristics over time.

• Unique Technical Hurdles:

  • Polymorphism: The active pharmaceutical ingredient (API) may exist in various crystalline forms. Using an incorrect form can negatively impact solubility, bioavailability, and stability.

  • Particle Size Engineering: Achieving consistent flow, compaction, and dissolution requires matching the particle size distribution of the API and excipients. However, the original specifications are often unknown.

  • Excipient Functionality: Sourcing generic excipients that precisely replicate the behavior of innovator-specific grades can be challenging, potentially affecting tablet hardness, disintegration, or dissolution.

  • Process Robustness: Developing a manufacturing process that consistently produces a bioequivalent product, despite variations in raw materials or equipment, necessitates extensive trial and error.

 4.2 Walter Healthcare: Your Strategic CDMO Partner for Off-Patent Drug Development

Developing off-patent drugs requires specialized expertise beyond standard manufacturing. Walter Healthcare, as a robust CDMO partner, provides significant value in this complex landscape by offering comprehensive, end-to-end support throughout the product development lifecycle.

• Expertise Complex Formulation

Our quality checking team is adept at handling intricate drug formulations, including sustained-release systems, inhalation products, and long-acting injectables. They leverage advanced delivery platforms and robust Quality by Design (QbD) based optimization to guarantee bioequivalence and consistent batch quality.

• Tackling Stability Challenge

Walter effectively assists its clients in preventing degradation and extends shelf life for Active Pharmaceutical Ingredients (APIs) with stability issues or Fixed Dose Combinations (FDCs). This is achieved by implementing ICH-compliant stability protocols, specifically adapted for India's Zone IVb conditions.

• Overcoming Technical Hurdles:

The R&D and regulatory teams of Walter provide comprehensive support to mitigate development risks, including peptide degradation, NTI classification, and device-drug integration. They achieve this through customized BA/BE studies, high-quality CT-04/05 submissions, and expert CDSCO communication management.

• Accelerated Approvals and Market Advantage:

In-depth understanding of the New Drugs and Clinical Trials Rules (NDCTR) 2019 by Walter experts facilitates faster approvals and smoother compliance. This is crucial for achieving a first-to-launch advantage in the highly competitive post-patent market.

5. Regulatory Pathway Under NDCTR (2019)

In India, the launch of off-patent drugs is governed by the New Drugs and Clinical Trials Rules (NDCTR), 2019. Enforced by the Central Drugs Standard Control Organization (CDSCO), these regulations dictate the approval process, which is determined by the drug's regulatory status and the duration since its initial approval within the country.

5.1 Regulatory considerations of launching these off-patent products 

Classification Under NDCTR (2019)

Off-patent drugs may still be considered "New Drugs" under Indian regulations if:

• They were approved in India less than 4 years ago.

• They involve a new dosage form, strength, or route of administration that has not been previously approved.

Once 4 years have passed since a drug’s first approval in India, it is no longer classified as a "new drug" and can be approved at the state licensing level without CDSCO review.

Key Filing Requirements

If Already Approved in India (Over 4 Years Ago):

• Apply directly to the State FDA for a manufacturing license (Form 25). 

• Provide product dossier, stability data, and, if required, bioequivalence data.

If Approved in India (Within 4 Years):

• File Form CT-21 with CDSCO for marketing authorization.

• Submit:

  • Bioequivalence (BE) study protocol and data

  • Comparative dissolution profiles

  • Quality and stability data as per CTD format

If Not Approved in India Yet:

• File Form CT-20 to conduct a BE study in India.

• Post-study, submit Form CT-21 for marketing approval.

• Requires a complete technical dossier, BE results, and product characterization.

list of drugs going off patent globally by 2025 Special Considerations

• Peptides or complex injectables (e.g., semaglutide) may require additional data on sterility, comparability, and sometimes local clinical trials.

• BE waivers may be granted for certain injectables and solutions if the composition and route match the innovator exactly. 

• All submissions must align with ICH and CDSCO guidelines for stability, validation, and analytical testing.

5.2 State CDSCO’s NDCTR filing requirements for generic versions of patented molecules

No Clinical Trial Required (Unmodified Generics)

• For generics with identical salt, strength, and dosage form, a Bioavailability/Bioequivalence (BA/BE) study is sufficient, replacing a full clinical trial, provided there are no new indications or changes in delivery.

• Submit Form CT‑05 with all details per the Fourth Schedule, including:

  • Study protocol,

  • Sponsor and site details,

  • Ethics Committee approval,

  • Investigator information, and

  • Payment of the applicable fee

Clinical Trial Requirement 

A clinical trial is required for your generic if it introduces any of the following changes:

• Indication

• Dosage strength/formulation

• Delivery system

• Route of administration

In such cases:

• File Form CT‑04, including submission as per the Second Schedule: full protocol, investigator info, Ethics Committee (registered), sponsor details, and fees.

• Once approved, CDSCO grants Form CT‑06 for the clinical trial.

  Submission Requirements

6. Strategic Recommendations for Pharma Companies

6.1 Wise Product Choices Based on Market Demand and Technical Feasibility

• Molecule Priority With Solid Market Demand

Prioritize therapeutic areas with high demand in terms of oncology, diabetes, and cardiovascular diseases. Off-patent drugs in these areas remain widely prescribed due to the prevalence of chronic diseases. One such example is Sitagliptin (DPP-4 inhibitor for Type 2 Diabetes) – went off-patent in 2022. It had a large Indian market and prescriber loyalty, enabling Indian manufacturers like Sun Pharma and Glenmark to gain early traction.

• Drug Selection with Manageable Formulation and Stable Profile

Choosing off-patent drugs with existing, stable manufacturing processes and formulations is crucial. This approach helps overcome technical hurdles and significantly reduces the time it takes for a product to reach the market. One of the examples is Atorvastatin, a commonly prescribed statin. Its formulation as a film-coated tablet is straightforward; it remains stable under standard International Council for Harmonisation (ICH) conditions, and it can be easily manufactured on a large scale.

• Avoid Complex Biotech Molecules Unless Specialized Capabilities

Avoid venturing into biosimilars or complex injectables unless your research and development (R&D) and manufacturing facilities are equipped to manage biologics, lyophilized products, or liposomal delivery systems. A notable example is Trastuzumab (Herceptin), which, despite being off-patent, demands sophisticated biologics capabilities. Companies such as Biocon and Mylan achieved success in this area due to their advanced biologics infrastructure. 

• Leverage Off-Patent Drugs with Unmet Needs in Specified Segment

Focus on identifying pharmaceutical molecules where the expiration of patents doesn't automatically translate to widespread availability or affordability. This is particularly relevant in areas like smaller cities (Tier 2/3) or for drugs used in less common medical conditions. For example, Lenalidomide, a crucial drug for treating multiple myeloma, was previously very expensive, limiting its accessibility. After its patent expired, Indian pharmaceutical companies, such as Natco Pharma, introduced more affordable generic versions. This significantly broadened access to the drug, allowing more patients to benefit from it.

• Assess IP Landscape Beyond Composition Patent Expiry

Thorough intellectual property (IP) due diligence is crucial to confirm that no secondary patents, such as those related to polymorphs, formulations, or manufacturing processes, remain active and could impede market entry. A notable instance is Ezetimibe, a cholesterol absorption inhibitor. While its primary patent had expired, certain formulation patents subsequently postponed the introduction of generic versions for some companies that were not cognizant of these secondary patent obstacles.

6.2 Why collaborating with an experienced CDMO accelerates speed-to-market 

• End-to-end regulatory and Development Support under NDCTR 2019

Collaborating with an expert CDMO like Walter Healthcare will leverage extensive knowledge of India's regulatory landscape, including NDCTR 2019 and SUGAM portal submissions, to secure accelerated approvals and minimize regulatory hurdles. We also navigate clinical trial exemptions for faster, compliant filings. 

• Ready Infrastructure with Rapid Tech Transfer Capabilities

Integration approach with experienced CDMO significantly reduces the time and resources typically required for facility setup, validation, and batch optimization, allowing for a much faster time to market. Walter Healthcare offers GMP-certified manufacturing with advanced technology, modern analytical labs for testing, and a skilled tech transfer team to streamline production from lab to commercial scale. 

• Proven track Record with Complex Formulation

At the time of joining hands with the experienced CDMO like  Walter, who excels at developing complex formulations like sustained-release tablets, sterile injectables, and fixed-dose combinations with a high first-time-right success rate due to a science-backed, efficient development model. 

• Agile Project Management and Transparent Communication

Walter Healthcare, as your experienced CDMO, assigns a dedicated team member to each project, ensuring a single point of contact and consistent oversight. We also provide real-time collaboration tools that facilitate seamless communication and immediate issue resolution. This proactive approach minimizes development delays, streamlines decision-making processes, and ultimately leads to more predictable project timelines.

7. Conclusion

The period between 2025 and 2027 offers an unparalleled opportunity for pharmaceutical companies to capitalize on high-value drugs losing patent protection in India and worldwide. Companies that move swiftly into the generics space gain a significant competitive edge, benefiting from market share leadership, enhanced brand recognition, strong pricing power, and preferential access to key distribution channels. This strategic entry not only boosts profitability but also establishes companies as long-term leaders in vital therapeutic areas such as diabetes, oncology, cardiovascular, and CNS disorders. However, success in this highly time-sensitive and technically complex environment requires more than just speed; it demands precision, regulatory expertise, and advanced formulation capabilities. This is where Walter Healthcare excels. As a trusted CDMO partner, we offer comprehensive support, covering everything from product identification, regulatory submissions under NDCTR 2019, and bioequivalence (BE) study execution, to formulation development, technology transfer, and commercial manufacturing. At Walter Healthcare, we excel in navigating the complexities of generic drug development with precision, agility, and strict regulatory adherence. We ensure your products are launch-ready without compromise, from intricate formulations to accelerated time-to-market. If you're looking to explore opportunities in the off-patent space, now is the ideal time to establish a significant market presence. Let's work together to deliver high-quality, affordable medicines to patients more quickly and efficiently. Partner with Walter Healthcare for strategic support that aligns your product pipeline with both compliance and patient care.