A Look at 2024’s Patent Expirations and Generic Competition

The pharmaceutical industry faced a major shift in 2024 as several blockbuster drugs lost patent protection. This change brought challenges and opportunities for companies and patients. Pharmaceutical firms experienced revenue declines and tougher competition from generics and biosimilars. However, this shift increased access to affordable medications and drove the development of new treatments.

Every Blockbuster Faces the Inevitable: Generics Await

The passage of time brings different challenges for industries. Pharmaceutical executives are reminded of the need for new drug launches. They must replace revenue lost when patents expire. No matter how successful a drug is, it will eventually face competition from generics or biosimilars. Humira, a leader in immunology with over $21 billion in global sales, faced biosimilars in early 2023. It saw a significant decline last year. Each year, experts identify top drugs likely to face competition. They focus on drugs losing exclusivity in the upcoming year. These drugs include major products from Bristol Myers Squibb, Biogen, Novo Nordisk, Astellas, and Novartis. Others include drugs from PTC Therapeutics, Organon, Supernus, CSL, and Bausch + Lomb.

Sprycel (dasatinib) – Bristol Myers Squibb

Bristol Myers Squibb’s exclusivity for Sprycel, a treatment for chronic myeloid leukemia (CML), expired after years of legal battles. The company reached settlements with Apotex and other undisclosed firms, clearing the way for generics to enter the market in September 2024. Sprycel, which had revolutionized CML treatment with tyrosine kinase inhibitors, continued to generate strong sales in 2023, bringing in $1.45 billion in U.S. revenue. Generics from companies like Biocon, Lupin, and Dr. Reddy’s were expected to launch, while Xspray Pharma prepared a lower-dose version designed to reduce side effects, with an anticipated 2024 approval and launch.

Tysabri (natalizumab) – Biogen

Biogen’s Tysabri, a key treatment for multiple sclerosis and Crohn’s disease, faced increasing competition as Sandoz launched a biosimilar, Tyruko, in 2024. After Biogen lost a patent infringement lawsuit against Sandoz, the biosimilar received FDA approval. Sandoz began rolling out Tyruko in both the U.S. and Europe, which increased access to this essential medication. Despite the biosimilar competition, Biogen remained focused on maintaining Tysabri’s market position, which generated $998 million in U.S. sales in 2023.

Myrbetriq (mirabegron) – Astellas

Myrbetriq, used to treat overactive bladder, faced legal uncertainty after a U.S. court invalidated a key 2030 patent in June 2023. Astellas won a new 2030 patent and sued generics companies to delay their market entry. Myrbetriq’s regulatory exclusivity expired in September 2024, with some patents ending in May 2024. Generic versions from Lupin, Alkem, and Aurobindo were either approved or tentatively approved, with Lupin having eyed a 2024 launch. Despite this, Myrbetriq generated $640 million in U.S. sales in 2023, having been granted FDA approval in 2012, and Astellas had not yet provided guidance on the impact of generics.

Victoza (liraglutide) – Novo Nordisk

Victoza, Novo Nordisk’s first-generation GLP-1 type 2 diabetes treatment, faced generic competition in June 2024 after 14 years of exclusivity. Once a growth driver, Victoza’s U.S. sales fell sharply to $525 million in 2023, overshadowed by newer GLP-1 drugs like Ozempic, which achieved sales nearly 17 times higher.

Generic contenders Teva, Viatris, and Sandoz secured settlements with Novo, allowing mid-2024 launches, though none had FDA approval at the time. With patents expired in major markets and shortages easing, Victoza’s decline marked the end of an era, as Novo dominated the GLP-1 market with its newer therapies.

Emflaza (deflazacort) – PTC Therapeutics

Emflaza, a treatment for Duchenne muscular dystrophy, faced generic competition after India’s Aurobindo received FDA approval for a generic in January 2024. The drug’s patents and exclusivity had largely expired, leaving only limited exclusivity until 2026. Emflaza’s U.S. sales reached $255 million in 2023, but its high price and public backlash led PTC Therapeutics to acquire the drug from Marathon Pharma in 2017. PTC also struggled with its other DMD treatment, Translarna, which faced regulatory setbacks.

Sandostatin LAR (octreotide acetate) – Novartis

Novartis developed Sandostatin LAR to treat acromegaly and severe diarrhea caused by carcinoid tumors. It lost U.S. patent protections years ago. However, the drug largely avoided generic competition due to its complex manufacturing process. In 2024, Viatris, a generics maker, prepared to launch its version after submitting it for FDA approval. Viatris aimed to make a significant move in its generics pipeline by being one of the first to enter the market.

The FDA first approved Sandostatin LAR in 1998. Its sales declined sharply over the years, dropping from $853 million in 2016 to just $199 million in 2023. Novartis credited the drug’s difficult production process for its long-standing market dominance. This process kept generics from entering the U.S. market until now.

Dulera (mometasone furoate / formoterol fumarate dihydrate) – Organon

Organon’s Dulera, an asthma medication, experienced fluctuating sales since its approval in 2010. Initially anticipated to be a blockbuster, the drug’s sales peaked at $536 million in 2015 but steadily declined, dropping to $156 million by 2023. Dulera struggled to compete with similar drugs, such as GSK’s Breo, which contributed to its decline. The FDA approved Dulera for asthma treatment but rejected its use for chronic obstructive pulmonary disease (COPD) in 2012.

Although Dulera lost its patent in 2020, it had not faced generic competition in the U.S. as of late 2023. Organon anticipated this would change in the second half of 2024. To this end, Lupin made significant progress in June 2023 when it received FDA approval for its generic version of Boehringer Ingelheim’s Spiriva. At the time, the company noted it was the first from India to secure approval for a dry powder inhaler. Organon’s inhaler-based formulation complicated generic development, delaying any approvals. Despite these challenges, the company saw slight sales growth in 2023, driven by price increases and expanded demand following the FDA’s 2019 approval to extend its use to children as young as five.

Oxtellar XR (oxcarbazepine) – Supermus Pharmaceuticals

Supernus Pharmaceuticals lost market exclusivity for its epilepsy drug Oxtellar XR in September 2024. The sales impact was less severe than the 2023 loss of exclusivity for Trokendi XR. Oxtellar XR, approved in 2012 as an adjuvant therapy and later as a monotherapy, generated over $100 million in sales in 2021. By 2023, sales declined to $113 million. Supernus had fought off generic threats from Actavis and TWi Pharma. It settled with Apotex in 2023, allowing the Canadian firm to launch a generic version in September 2024. Generic competition, which had already impacted Trokendi XR’s sales, accelerated Oxtellar XR’s decline.

Despite these challenges, Supernus positioned itself for future growth. Its ADHD drug Qelbree generated $140 million in sales in 2023. The company also acquired Adamas Pharmaceuticals in 2021, adding the dyskinesia drug Gocovri to its portfolio.

Venofer (iron sucrose) – CSL Behring

CSL Behring acquired Venofer, an injectable iron therapy, when it purchased Vifor Pharma in late 2021. The drug treats iron deficiency anemia in patients with chronic kidney disease or other medical conditions. CSL Behring has positioned Venofer as a key part of its portfolio, capitalizing on the growing demand for iron therapies. The company has expanded the product’s availability globally.

By acquiring Vifor, CSL Behring strengthened its presence in the iron deficiency space, aligning with its broader strategy to lead in rare and serious diseases. Venofer remains a critical therapeutic option, and CSL is focusing on leveraging its market presence to solidify its position in the global iron deficiency treatment market.

Prolensa (bromfenac) – Bausch + Lomb

Bausch + Lomb developed Prolensa, a once-daily bromfenac solution approved by the FDA in 2013. It treats postoperative eye inflammation after cataract surgery. Clinical trials showed 46% of users achieved complete inflammation clearance by Day 15. Despite competition from existing bromfenac products like Xibrom and Bromday, Prolensa generated $113 million in sales by 2017.

Generic competition emerged early. Lupin filed a generic application in 2013. In 2024, Lupin launched its generic version after receiving FDA approval. Lupin secured 180 days of market exclusivity. Prolensa’s sales fell to $41.5 million in 2023, contributing 1% to Bausch + Lomb’s total revenue of $4.15 billion.

Other Drugs That Faced Patent Expirations and Generic Competition in 2024

UCB’s Neupro faced potential generic competition, but UCB scheduled a trial with Viatris for 2024, making the timing uncertain. Merck’s HIV drug, Isentress, lost patent protection in 2024. However, Merck did not expect U.S. generic competition that year. GSK’s Flovent inhaler was excluded due to its status as an authorized generic launched by Prasco in 2022. No other generics were ready to enter the market, so it was left out. Myrbetriq was included despite legal uncertainties, as Lupin was confident about launching its version in 2024. In 2025, biosimilars for Johnson & Johnson’s Stelara were set to launch. Stelara had nearly $7 billion in U.S. sales the previous year. Amgen planned to lead the biosimilar race with a January launch.

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