2028 is going to be a landmark year in the pharmaceutical industry. Several blockbuster drugs, each with billion-dollar sales projections, will lose patent exclusivity, opening the door for Para IV filings.
For generic and biosimilar manufacturers, this represents a great opportunity. With the right data, the right timing, and tools like NCE Grid to track NCE-1 dates and exclusivity timelines, it is now possible for companies to prepare for Para IV filings, launch development programs, and scale fast into impactful therapeutic categories.
Here’s a breakdown of the top 10 drugs set to lose exclusivity in 2028:
1. Bimzelx
- Therapy Area: Immunomodulators (Psoriasis)
- Innovator: UCB INC
- 2028 Sales Forecast: $4,157M
Para IV Insight: Fast-growing specialty biologic. Ideal for early biosimilar competition.
2. Leqembi
- Therapy Area: Antialzheimers
- Innovator: EISAI INC
- 2028 Sales Forecast: $3,368M
Para IV Insight: Alzheimer’s therapy with explosive growth—entry here can redefine access.
3. Paxlovid
- Therapy Area: Antiviral (COVID-19)
- Innovator: PFIZER INC
- 2028 Sales Forecast: $3,282M
Para IV Insight: Still valuable during viral surges—high-volume generic potential.
4. Beyfortus
- Therapy Area: Antiviral (RSV Prevention)
- Innovator: SANOFI
- 2028 Sales Forecast: $3,276M
Para IV Insight: Pediatric preventive space, biosimilars can drive massive public health value.
5. Epkinly
- Therapy Area: Anticancer (Lymphoma)
- Innovator: GENMAB & ABBVIE
- 2028 Sales Forecast: $2,560M
Para IV Insight: Cutting-edge immunotherapy. Timely generics can offer huge cost savings.
6. Fabhalta
- Therapy Area: Immunomodulators (PNH)
- Innovator: NOVARTIS
- 2028 Sales Forecast: $1,818M
Para IV Insight: Rare-disease treatment. Early generic entry can relieve pricing pressure.
7. Jaypirca
- Therapy Area: Anticancer (Mantle Cell Lymphoma)
- Innovator: LOXO ONCOLOGY INC
- 2028 Sales Forecast: $1,509M
Para IV Insight: Solid brand trust. Generic competition can open new access pathways.
8. Wainua
- Therapy Area: Neuroprotective (Hereditary Amyloidosis)
- Innovator: ASTRAZENECA AB
- 2028 Sales Forecast: $1,485M
Para IV Insight: Orphan drug with high unmet need. A key niche for generic expansion.
9. Ogsiveo
- Therapy Area: Anticancer (Desmoid Tumors)
- Innovator: SPRINGWORKS THERAPEUTICS INC
- 2028 Sales Forecast: $1,432M
Para IV Insight: Novel therapy for rare tumors — generics can enhance accessibility.
10. Ojjaara
- Therapy Area: Anticancer (Myelofibrosis)
- Innovator: GLAXOSMITHKLINE LLC
- 2028 Sales Forecast: $1,401M
Para IV Insight: Chronic therapy with durable demand—generic options can drive down cost long-term.
To know more features like dosage form, NCE-1 date, and strength, visit the NCE Grid.
Track Para IV Filing Opportunities Smarter with NCE Grid
Manually tracking Para IV opportunities, exclusivity dates, and NCE-1 filings is a complex and time-consuming process.
NCE Grid Simplifies Para IV Filing by:
- Monitoring NCE and NCE-1 dates
- Searching by molecule, therapeutic area, or innovator
- Spotting high-growth opportunities earlier than your competition
- Planning Para IV filings well before the 2028
Whether you’re scouting early-stage pipeline ideas or preparing a robust launch plan, NCE Grid turns data into action.
Conclusion
The loss of exclusivity for these 10 drugs marks more than a regulatory milestone. It’s a great opportunity for generic and biosimilar companies to lead the next wave of access and affordability.
With the right insights and tools like NCE Grid, you can be first in line to file Para IVs, develop cost-effective alternatives for the branded drugs, and scale your impact across markets and specific therapeutic areas.
Contact us to learn more about our specialized, integrated clinical trial supply services, combined with the NCE Grid platform, which makes a significant difference in your clinical trial studies.
