JEMPERLI Drug Profile

Summary for Tradename: JEMPERLI

High Confidence Patents:	0
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for JEMPERLI

Recent Clinical Trials for JEMPERLI

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Yonsei University	Phase 2
GERCOR - Multidisciplinary Oncology Cooperative Group	Phase 2
Casey Cosgrove	Phase 2

See all JEMPERLI clinical trials

Pharmacology for JEMPERLI

Mechanism of Action	Programmed Death Receptor-1-directed Antibody Interactions
Established Pharmacologic Class	Programmed Death Receptor-1 Blocking Antibody

Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

1. Brand-side disclosures in response to biosimilar applications

These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

2. DrugPatentWatch analysis and company disclosures

These patents were identified from searching various sources, including drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

3. Patents from broad patent text search

For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for JEMPERLI Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for JEMPERLI Derived from DrugPatentWatch Analysis and Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for JEMPERLI Derived from Patent Text Search

No patents found based on company disclosures

JEMPERLI Market Dynamics, Sales Trajectory, Exclusivity and Patent Risk

Last updated: September 8, 2026

JEMPERLI, the brand name for dostarlimab-gxly, is GSK’s PD-1 inhibitor for mismatch repair-deficient or microsatellite instability-high endometrial cancer. Its commercial outlook improved materially after FDA approval of the carboplatin-paclitaxel combination in 2024. The main growth drivers are broader first-line use, expansion through biomarker testing, and potential additional solid-tumor indications. The main constraints are a concentrated endometrial-cancer market, competition from pembrolizumab-based regimens, limited near-term use outside dMMR or MSI-H disease, and eventual biosimilar competition after biologic exclusivity expires.

What is JEMPERLI approved to treat?

JEMPERLI is an anti-PD-1 monoclonal antibody developed by Tesaro and acquired by GSK through its $5.1 billion acquisition of Tesaro in 2019. The active ingredient is dostarlimab-gxly.

FDA milestone	Date	Commercial significance
Accelerated approval for dMMR recurrent or advanced solid tumors after prior treatment	April 2021	Established the initial tissue-agnostic indication
Accelerated approval for dMMR recurrent or advanced endometrial cancer after platinum therapy	April 2021	Created the initial core market
Regular approval for dMMR recurrent or advanced endometrial cancer after prior platinum-containing regimen	August 2023	Converted the principal endometrial indication to traditional approval
Approval with carboplatin and paclitaxel for primary advanced or recurrent dMMR endometrial cancer	August 2024	Moved JEMPERLI into first-line combination treatment

The 2024 approval is commercially important because first-line treatment generates more eligible patients and longer treatment exposure than a later-line monotherapy indication. The approved population remains biomarker-defined, with dMMR status required for the combination indication under the FDA label (FDA, 2024a).

How large is the JEMPERLI market?

JEMPERLI competes in a broader immuno-oncology market dominated by Keytruda, Opdivo and Tecentriq. Its directly addressable market is narrower because the strongest approved use is linked to dMMR or MSI-H tumors, especially endometrial cancer.

Endometrial cancer is the central commercial market. In the United States, approximately 67,000 new endometrial-cancer cases were expected in 2024, according to the American Cancer Society. A minority of tumors are dMMR or MSI-H, but that subgroup has a high treatment need and is identifiable through routine molecular testing.

The 2024 first-line label allows JEMPERLI to compete with:

• Keytruda plus carboplatin and paclitaxel, followed by pembrolizumab maintenance, in advanced or recurrent endometrial cancer.
• Keytruda plus lenvatinib in advanced endometrial cancer after prior systemic therapy when the tumor is not MSI-H or dMMR.
• Single-agent PD-1 or PD-L1 therapies used in biomarker-defined disease.
• Chemotherapy alone, hormonal therapy and clinical-trial combinations.

JEMPERLI’s principal differentiation is the combination of dostarlimab with chemotherapy in dMMR endometrial cancer. The market opportunity is less dependent on treatment-line expansion than on gaining share against pembrolizumab in the first-line setting.

What are JEMPERLI’s sales and financial trajectory?

GSK reported JEMPERLI sales of approximately £97 million in 2023, compared with about £74 million in 2022. The increase reflected greater uptake in recurrent or advanced endometrial cancer and wider use of dMMR testing (GSK, 2024).

Fiscal year	Reported sales	Key driver
2021	Early commercial sales	Initial U.S. launch after accelerated approval
2022	Approximately £74 million	Expansion in recurrent or advanced endometrial cancer
2023	Approximately £97 million	Conversion to regular approval and continued U.S. uptake
2024 onward	Growth phase	First-line combination approval and broader treatment duration

The revenue trajectory should accelerate after the 2024 approval, but the impact will not be immediate. Commercial adoption depends on:

1. Guideline inclusion and treatment-pathway changes.
2. Oncologist preference between JEMPERLI and Keytruda-based regimens.
3. Availability and reimbursement of dMMR testing.
4. The proportion of eligible patients receiving combination therapy.
5. Maintenance-treatment duration and discontinuation rates.
6. GSK’s ability to secure favorable formulary and payer positioning.

JEMPERLI is not currently a GSK-scale revenue driver comparable with respiratory products such as Trelegy or vaccines such as Shingrix. Its strategic value is its growth rate, oncology platform potential and use of GSK’s commercial infrastructure. The product also carries relatively high gross-margin characteristics typical of an antibody, although combination treatment increases total regimen cost for payers.

When does JEMPERLI lose exclusivity?

JEMPERLI’s principal U.S. regulatory exclusivity is expected to run until April 22, 2033, based on the 12-year reference-product exclusivity period for the original biologic license approval in 2021.

Exclusivity type	Approximate end date	Assessment
U.S. biologic reference-product exclusivity	April 22, 2033	Twelve years from initial BLA approval
Pediatric exclusivity	Not established publicly	Could add six months if FDA requirements are satisfied
Patent protection	Patent-specific	Requires analysis of individual patent families and terminal disclaimers
Biosimilar approval pathway	Potentially from 2033, subject to patent litigation	FDA approval does not guarantee immediate market entry

The 12-year biologic exclusivity period is separate from patent protection. A biosimilar sponsor can file an application before the end of exclusivity and may challenge patents before commercial launch. Patent litigation, settlement terms and injunctions can extend practical market protection beyond the regulatory date.

What patents protect JEMPERLI?

JEMPERLI is a biologic, so its protection is divided among composition-of-matter, antibody-sequence, manufacturing, formulation and use patents. FDA’s Orange Book is not the primary patent database for a product approved through a biologics license application. JEMPERLI’s principal regulatory record is maintained through the Purple Book rather than through an Orange Book patent listing.

The likely patent categories include:

Patent category	Protected subject matter	Commercial relevance
Antibody composition	Dostarlimab antibody sequences and binding characteristics	Core product protection
Anti-PD-1 use	Treatment of tumors using PD-1 blockade	May protect selected indications
Biomarker-selected use	dMMR or MSI-H tumors	Could support indication-specific enforcement
Combination therapy	Dostarlimab with platinum chemotherapy or other agents	Potentially relevant to first-line treatment
Formulation	Concentration, stabilizers, containers and storage	Can complicate substitution
Manufacturing	Cell culture, purification and antibody production processes	May create supply-chain barriers

Publicly available FDA materials do not provide a simple, consolidated JEMPERLI patent table equivalent to a conventional small-molecule Orange Book listing. Patent expiry must therefore be assessed at the family level, including continuations, divisionals, terminal disclaimers, PTA and PTE.

No major U.S. Paragraph IV litigation risk applies in the same way as it does to an orally administered small molecule. JEMPERLI’s principal future challenge is expected to involve biosimilar patent litigation under the Biologics Price Competition and Innovation Act.

What is the Orange Book and Purple Book status of JEMPERLI?

JEMPERLI is regulated as a biologic under a BLA. Its reference-product status is therefore more relevant than an Orange Book listing.

Regulatory issue	JEMPERLI status
FDA regulatory pathway	Biologics license application
Active ingredient	Dostarlimab-gxly
Reference product	Yes
Biosimilar pathway	Available under the BPCIA
Orange Book patent certification	Not the primary framework
Purple Book relevance	High
Interchangeability	No approved interchangeable biosimilar publicly established through mid-2024

A future biosimilar would need to demonstrate biosimilarity to the reference product. Interchangeability is a separate designation and is not necessary for all substitution or market-entry scenarios, depending on state pharmacy law and payer policy.

Which companies are challenging JEMPERLI?

No publicly established U.S. biosimilar competitor had launched JEMPERLI as of mid-2024. Potential competition is more likely to arise from large biologics manufacturers with oncology manufacturing capacity, including Amgen, Celltrion, Biocon Biologics, Samsung Bioepis, Sandoz and Fresenius Kabi. This is a potential competitor set, not a confirmed list of JEMPERLI biosimilar applicants.

The more immediate competitive threat is commercial rather than legal. Merck’s Keytruda has broader endometrial-cancer data, a larger treatment ecosystem and established payer access. Its first-line combination with carboplatin and paclitaxel directly overlaps with JEMPERLI’s 2024 approval.

How does JEMPERLI compare with Keytruda in endometrial cancer?

Factor	JEMPERLI	Keytruda
Active ingredient	Dostarlimab	Pembrolizumab
Class	PD-1 inhibitor	PD-1 inhibitor
Core biomarker opportunity	dMMR/MSI-H	dMMR/MSI-H plus broader approved settings
First-line combination	With carboplatin and paclitaxel in dMMR disease	With carboplatin and paclitaxel in advanced or recurrent disease
Later-line positioning	dMMR recurrent or advanced endometrial cancer	Multiple endometrial-cancer settings
Commercial scale	Smaller oncology franchise	Much larger global oncology franchise
Competitive advantage	Focused dMMR strategy and GSK execution	Brand scale, broad label and established prescribing base

JEMPERLI’s clinical and commercial case is strongest in dMMR endometrial cancer. Keytruda retains an advantage in breadth, physician familiarity, combination development and global commercial reach.

What clinical expansion could increase JEMPERLI revenue?

GSK has pursued a tissue-agnostic development strategy based on dMMR and MSI-H biology. Potential expansion areas include colorectal cancer and other advanced solid tumors. A small prospective study of dostarlimab in locally advanced rectal cancer produced a high complete response rate in a selected dMMR population, but that result does not itself establish a broad commercial indication.

The major expansion opportunities are:

• Earlier-line endometrial cancer.
• Additional dMMR solid tumors.
• Neoadjuvant or adjuvant treatment.
• Combination regimens with chemotherapy, targeted agents or radiotherapy.
• International markets with increasing molecular-testing penetration.

The largest execution risk is that the biomarker-defined population remains comparatively small. Clinical success outside endometrial cancer is required for JEMPERLI to become a major oncology product rather than a focused specialty franchise.

What litigation and settlement risks affect JEMPERLI?

There was no widely reported major U.S. JEMPERLI patent trial or Paragraph IV settlement through mid-2024. Future litigation risk is concentrated in four areas:

1. Patent infringement claims against biosimilar applicants.
2. Validity challenges involving antibody sequence or use patents.
3. Patent disputes over combination treatment.
4. Manufacturing-process and formulation claims.

A biosimilar settlement could establish a launch date before April 2033 if GSK agrees to waive or narrow enforcement rights. The economic value of such a settlement would depend on the strength of remaining patents, the size of the dMMR market and the expected discount to JEMPERLI.

What generic and biosimilar launch risks exist?

Traditional generic competition is not the relevant risk because JEMPERLI is an antibody. Biosimilar entry is the relevant long-term threat.

The commercial impact of biosimilar entry may be slower than for small molecules because:

• Oncology treatment is administered through specialist channels.
• Hospital and payer procurement can favor low-cost alternatives.
• Physicians may continue established products in high-risk patients.
• Interchangeability and substitution rules vary.
• Manufacturing capacity can constrain early supply.
• GSK may defend market share through contracting and lifecycle management.

A first biosimilar could produce price erosion, but the magnitude would depend on the number of entrants. One competitor may create moderate discounting; several competitors could produce materially greater erosion.

What manufacturing and intellectual-property barriers protect JEMPERLI?

Dostarlimab is a complex monoclonal antibody requiring controlled cell-line development, upstream production, purification, viral clearance, analytical characterization and sterile fill-finish. These requirements create higher barriers than those faced by a conventional generic-drug manufacturer.

Manufacturing barriers include:

• Reproducing the antibody’s critical quality attributes.
• Demonstrating comparable glycosylation and impurity profiles.
• Establishing a reliable commercial cell-culture process.
• Validating cold-chain and storage conditions.
• Scaling production without affecting clinical performance.

These barriers do not prevent biosimilar entry, but they can reduce the number of viable competitors and delay launch after approval.

What is the investment outlook for JEMPERLI?

JEMPERLI has a credible growth profile but remains a concentrated asset. Its near-term value depends on first-line adoption in dMMR endometrial cancer. Its long-term value depends on successful expansion into additional dMMR tumors and protection against biosimilar erosion.

The most important indicators are:

• U.S. quarterly sales growth after the 2024 label expansion.
• Duration of therapy in first-line patients.
• Market share against Keytruda combinations.
• dMMR testing rates.
• European and Japanese reimbursement.
• New clinical data in colorectal and other solid tumors.
• Patent-family strength and biosimilar filing activity.

JEMPERLI is more likely to become a meaningful specialty-oncology product than a broad PD-1 market leader. The 2033 biologic exclusivity date provides a long regulatory runway, but commercial durability depends on clinical differentiation and lifecycle execution.

Key Takeaways

• JEMPERLI is dostarlimab-gxly, a GSK PD-1 inhibitor focused on dMMR or MSI-H cancers.
• FDA approval in August 2024 expanded JEMPERLI into first-line advanced or recurrent dMMR endometrial cancer with carboplatin and paclitaxel.
• GSK reported approximately £97 million in 2023 sales, up from about £74 million in 2022.
• U.S. reference-product biologic exclusivity is expected to run through April 22, 2033, before any pediatric extension.
• The primary commercial competitor is Keytruda, not a conventional generic.
• The principal near-term opportunity is first-line dMMR endometrial cancer.
• The principal long-term risk is biosimilar entry combined with competition from pembrolizumab-based regimens.
• JEMPERLI’s patent assessment requires family-level review because it is a BLA-approved biologic without a conventional Orange Book patent framework.

FAQs

Is JEMPERLI chemotherapy?

No. JEMPERLI is an immune checkpoint inhibitor that blocks the PD-1 receptor. In its first-line endometrial-cancer indication, it is administered with carboplatin and paclitaxel chemotherapy.

Is JEMPERLI approved for colorectal cancer?

JEMPERLI’s FDA approvals through mid-2024 do not establish a broad colorectal-cancer indication. Clinical data in dMMR rectal cancer are significant but remain separate from an approved commercial label.

Does JEMPERLI have an interchangeable biosimilar?

No interchangeable JEMPERLI biosimilar had been approved publicly through mid-2024.

What biomarker is required for first-line JEMPERLI treatment?

The FDA first-line combination indication requires dMMR status. dMMR is commonly assessed through immunohistochemistry, microsatellite-instability testing or validated molecular methods.

Is JEMPERLI protected by patents after 2033?

Potentially. The April 2033 date reflects biologic regulatory exclusivity, not every patent expiry. Individual antibody, formulation, manufacturing and method-of-use patents may expire earlier or later, subject to validity, enforceability and litigation outcomes.

References

1. American Cancer Society. (2024). Key statistics for endometrial cancer. https://www.cancer.org/cancer/types/endometrial-cancer/about/key-statistics.html

2. GlaxoSmithKline plc. (2024). Annual report 2023. https://www.gsk.com/en-gb/investors/annual-report/

3. U.S. Food and Drug Administration. (2021). FDA grants accelerated approval to dostarlimab-gxly for mismatch repair deficient solid tumors. https://www.fda.gov/

4. U.S. Food and Drug Administration. (2023). FDA grants regular approval to dostarlimab-gxly for dMMR advanced or recurrent endometrial cancer. https://www.fda.gov/

5. U.S. Food and Drug Administration. (2024a). FDA approves dostarlimab-gxly with carboplatin and paclitaxel for primary advanced or recurrent endometrial cancer. https://www.fda.gov/

6. U.S. Food and Drug Administration. (2024b). Purple Book: Database of licensed biological products. https://purplebooksearch.fda.gov/

7. U.S. Food and Drug Administration. (2024c). JEMPERLI prescribing information. GlaxoSmithKline. https://gskpro.com/ content/dam/global/hcpportal/en_US/Prescribing_Information/Jemperli/pdf/JEMPERLI-PI-PIL.PDF

8. U.S. Congress. (2010). Biologics Price Competition and Innovation Act of 2009, Pub. L. No. 111-148, §§ 7001-7003.