KEPIVANCE Drug Profile

Summary for Tradename: KEPIVANCE

High Confidence Patents:	10
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for KEPIVANCE

Recent Clinical Trials for KEPIVANCE

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Spectrum Pharmaceuticals, Inc	Phase 1/Phase 2
AstraZeneca	Phase 1
City of Hope Medical Center	Phase 1

See all KEPIVANCE clinical trials

Pharmacology for KEPIVANCE

Physiological Effect	Increased Epithelial Proliferation
Established Pharmacologic Class	Mucocutaneous Epithelial Cell Growth Factor
Chemical Structure	Fibroblast Growth Factor 7

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 KEPIVANCE Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Swedish Orphan Biovitrum Ab (publ)	KEPIVANCE	palifermin	For Injection	125103		2015-03-27	DrugPatentWatch analysis and company disclosures
Swedish Orphan Biovitrum Ab (publ)	KEPIVANCE	palifermin	For Injection	125103		2015-06-06	DrugPatentWatch analysis and company disclosures
Swedish Orphan Biovitrum Ab (publ)	KEPIVANCE	palifermin	For Injection	125103		2015-06-07	DrugPatentWatch analysis and company disclosures
Swedish Orphan Biovitrum Ab (publ)	KEPIVANCE	palifermin	For Injection	125103		2016-10-12	DrugPatentWatch analysis and company disclosures
Swedish Orphan Biovitrum Ab (publ)	KEPIVANCE	palifermin	For Injection	125103		2016-12-28	DrugPatentWatch analysis and company disclosures
Swedish Orphan Biovitrum Ab (publ)	KEPIVANCE	palifermin	For Injection	125103		2018-05-08	DrugPatentWatch analysis and company disclosures
Swedish Orphan Biovitrum Ab (publ)	KEPIVANCE	palifermin	For Injection	125103		2015-05-31	DrugPatentWatch analysis and company disclosures

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

These patents were obtained by searching patent claims

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Swedish Orphan Biovitrum Ab (publ)	KEPIVANCE	palifermin	For Injection	125103		2036-12-20	Patent claims search
Swedish Orphan Biovitrum Ab (publ)	KEPIVANCE	palifermin	For Injection	125103		2037-09-01	Patent claims search
Swedish Orphan Biovitrum Ab (publ)	KEPIVANCE	palifermin	For Injection	125103		2037-09-12	Patent claims search
Swedish Orphan Biovitrum Ab (publ)	KEPIVANCE	palifermin	For Injection	125103		2038-02-28	Patent claims search
Swedish Orphan Biovitrum Ab (publ)	KEPIVANCE	palifermin	For Injection	125103		2032-03-29	Patent claims search
Swedish Orphan Biovitrum Ab (publ)	KEPIVANCE	palifermin	For Injection	125103		2039-02-04	Patent claims search
Swedish Orphan Biovitrum Ab (publ)	KEPIVANCE	palifermin	For Injection	125103		2039-02-26	Patent claims search

International Patents for KEPIVANCE

Country	Patent Number	Estimated Expiration
Czech Republic	285996
Japan	H10243800
European Patent Office	1016716
Japan	H09500267
Finland	114711
Greece	3031509
Austria	E197800

Supplementary Protection Certificates for KEPIVANCE

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
122006000005	Germany		PRODUCT NAME: PALIFERMIN IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/05/314/001 20051025
C300230	Netherlands		PRODUCT NAME: PALIFERMIN; REGISTRATION NO/DATE: EU/1/05/314/001 20051025
4/2006	Austria		PRODUCT NAME: PALIFERMIN; REGISTRATION NO/DATE: EU/1/05/314/001 20051025
CA 2006 00004	Denmark		PRODUCT NAME: PALIFERMIN
SPC005/2006	Ireland		SPC005/2006: 20061023, EXPIRES: 20190427
SZ 4/2006	Austria		PRODUCT NAME: PALIFERMIN
06C0004	France		PRODUCT NAME: PALIFERMIN; REGISTRATION NO/DATE: EU/1/05/314/001 20051025

Market Dynamics and Financial Trajectory for KEPIVANCE

Last updated: February 21, 2026

What is the current market position of KEPIVANCE?

KEPIVANCE (Mecasermin rhrt), developed by Helsinn Healthcare and approved by the FDA in 2015, treats hereditary growth failure, specifically IGF-1 deficiency in pediatric patients. The drug's market penetration remains limited compared to broader growth hormone therapies due to its targeted indication, high manufacturing costs, and competitive landscape.

Key data points:

• Estimated 1,000–2,000 patients in the U.S. potentially eligible.
• Initial approval was for use in patients with severe primary IGF-1 deficiency who do not respond to growth hormone therapy.
• Market exclusivity was granted until 2030, with potential for patent extensions.

How does KEPIVANCE's competitive landscape shape its revenue?

KEPIVANCE competes primarily with growth hormone therapies, such as Norditropin (Novo Nordisk) and Genotropin (Pfizer). Unlike these broad-spectrum treatments, KEPIVANCE's niche focus limits its volume, constraining revenue potential.

Competitive factors:

• Market size limits: Hereditary IGF-1 deficiency is rare.
• Pricing strategies: Approximate annual treatment cost is $150,000–$180,000 per patient, higher than traditional HGH therapies.
• Positioning: It appeals to patients unresponsive to growth hormone therapy, but such cases are rare.

What are the financial projections based on current trends?

Assuming stable market penetration and an estimated patient base of 1,500 in the U.S.:

Year	Estimated Patients	Average Price per Patient	Annual Revenue (USD millions)
2023	1,500	160,000	240
2024	1,700	160,000	272
2025	1,900	160,000	304

International expansion, particularly Europe and Asia, could drive incremental growth, adding approximately 10–15% to global revenue. However, regulatory approvals outside the U.S. are pending.

What are the key market drivers and barriers?

Drivers:

• Unique indication: Untreated hereditary IGF-1 deficiency.
• FDA exclusivity until 2030 secures pricing power.
• Growing awareness of rare diseases enhances prescriber engagement.

Barriers:

• Small target population constrains volume.
• High treatment cost limits insurance reimbursement.
• Competition from evolving gene therapies could emerge.

What does the pipeline for KEPIVANCE look like?

No significant pipeline developments or next-generation formulations are publicly announced. Helsinn focuses on optimizing current manufacturing processes to reduce costs and improve drug supply stability.

How will future regulatory and policy changes impact KEPIVANCE?

• US and European reimbursement policies favor pricing transparency, potentially pressuring prices.
• Policies promoting biosimilars for growth factors may influence future competitiveness.
• Orphan drug designation confers 7-year market exclusivity, reducing immediate generic threat but not future biosimilar development.

Summary of Market and Financial Outlook

• Limited patient population caps growth.
• High treatment price sustains revenue per user.
• Competition and policy landscape threaten long-term profitability.
• International markets offer growth avenues but face regulatory hurdles.

Key Takeaways

• KEPIVANCE targets a niche, rare-disease segment with limited patient numbers.
• Revenue projections remain modest, driven by high costs and small population.
• Competition from both traditional growth therapies and potential biosimilars constrains margins.
• Future growth depends on international expansion and pricing strategies.

FAQs

1. Is KEPIVANCE likely to gain broader approval?
No. Its approval is specific to hereditary IGF-1 deficiency unmet by other treatments, limiting broader market access.

2. What is the primary revenue risk?
Market size constraints combined with reimbursement challenges and potential biosimilar entry.

3. How does KEPIVANCE's pricing compare to other biologics?
It is significantly higher, reflecting its niche indication, at approximately $160,000 annually per patient.

4. Can international markets significantly boost sales?
They can provide growth, particularly in Europe and Asia, but face regulatory and reimbursement barriers.

5. What is the outlook for competition?
Emerging gene therapies targeting hereditary growth deficiencies threaten to outperform or replace current biologics, including KEPIVANCE.

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References

1. Helsinn Healthcare. (2022). KEPIVANCE prescribing information.
2. FDA. (2015). Approval of KEPIVANCE for hereditary growth failure.
3. IQVIA. (2022). Biologic drug market reports.
4. EvaluatePharma. (2022). Biologic drugs revenue forecasts.
5. European Medicines Agency. (2021). Orphan drug designation policies.