TEPOTINIB HYDROCHLORIDE - Generic Drug Details

What are the generic drug sources for tepotinib hydrochloride and what is the scope of freedom to operate?

Tepotinib hydrochloride is the generic ingredient in one branded drug marketed by Emd Serono Inc and is included in one NDA. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Tepotinib hydrochloride has seventy-six patent family members in thirty-five countries.

One supplier is listed for this compound.

Summary for TEPOTINIB HYDROCHLORIDE

International Patents:	76
US Patents:	8
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	8
Clinical Trials:	23
Patent Applications:	47
What excipients (inactive ingredients) are in TEPOTINIB HYDROCHLORIDE?	TEPOTINIB HYDROCHLORIDE excipients list
DailyMed Link:	TEPOTINIB HYDROCHLORIDE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for TEPOTINIB HYDROCHLORIDE

Constraining patent/regulatory exclusivity:

8,580,781

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for TEPOTINIB HYDROCHLORIDE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
M.D. Anderson Cancer Center	Phase 1/Phase 2
Samsung Medical Center	Phase 2
Merck Serono GmbH, Germany	Phase 1

See all TEPOTINIB HYDROCHLORIDE clinical trials

Pharmacology for TEPOTINIB HYDROCHLORIDE

Drug Class	Kinase Inhibitor
Mechanism of Action	Mesenchymal Epithelial Transition Inhibitors P-Glycoprotein Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for TEPOTINIB HYDROCHLORIDE

L01EX	Other protein kinase inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for TEPOTINIB HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Emd Serono Inc	TEPMETKO	tepotinib hydrochloride	TABLET;ORAL	214096-001	Feb 3, 2021		RX	Yes	Yes	8,921,357		Y	Y
Emd Serono Inc	TEPMETKO	tepotinib hydrochloride	TABLET;ORAL	214096-001	Feb 3, 2021		RX	Yes	Yes	8,927,540
Emd Serono Inc	TEPMETKO	tepotinib hydrochloride	TABLET;ORAL	214096-001	Feb 3, 2021		RX	Yes	Yes	9,403,799
Emd Serono Inc	TEPMETKO	tepotinib hydrochloride	TABLET;ORAL	214096-001	Feb 3, 2021		RX	Yes	Yes	8,658,643
Emd Serono Inc	TEPMETKO	tepotinib hydrochloride	TABLET;ORAL	214096-001	Feb 3, 2021		RX	Yes	Yes

International Patents for TEPOTINIB HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
Ecuador	SP109957	DERIVADOS DE PIRIMIDINIL-PIRIDAZINONA.
Japan	2010532774
Spain	2614283
Taiwan	I501768
Chile	2008001392	Compuestos derivados de piridazinona, con actividad moduladora de quinasas; procedimiento de preparacion de dichos compuestos; composicion farmaceutica que comprende a dichos compuestos; kit farmaceutico; y uso para tratar un tumor solido.

Supplementary Protection Certificates for TEPOTINIB HYDROCHLORIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2164843	CA 2022 00021	Denmark		PRODUCT NAME: TEPOTINIB OG FARMACEUTISK ANVENDELIGE SOLVATER, SALTE, TAUTOMERER OG STEREOISOMERER DERAF; REG. NO/DATE: EU 1/21/1596 20220217
2164843	301176	Netherlands		PRODUCT NAME: TEPOTINIB EN FARMACEUTISCH AANVAARDBARE SOLVATEN EN ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/21/1596 20220217
2164843	PA2022009	Lithuania		PRODUCT NAME: TEPOTINIBAS IR FARMACINIU POZIURIU TINKAMI NAUDOTI JO SOLVATAI, DRUSKOS, TAUTOMERAI IR STEREOIZOMERAI ; REGISTRATION NO/DATE: EU/1/21/1596 20220216
2164843	CR 2022 00021	Denmark		PRODUCT NAME: TEPOTINIB OG FARMACEUTISK ANVENDELIGE SOLVATER, SALTE, TAUTOMERER OG STEREOISOMERER DERAF; REG. NO/DATE: EU 1/21/1596 20220217
2164843	C02164843/01	Switzerland		PRODUCT NAME: TEPOTINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68113 22.06.2021

TEPOTINIB HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Tepotinib Hydrochloride

Introduction

Tepotinib hydrochloride, marketed as Tepmetko, is a significant advancement in the treatment of non-small cell lung cancer (NSCLC) with MET exon 14 skipping alterations. This article delves into the market dynamics and financial trajectory of this drug, highlighting its approval, pricing, cost-effectiveness, and future prospects.

FDA Approval and Indication

Tepotinib received FDA approval on February 3, 2021, for the treatment of adult patients with locally advanced unresectable or metastatic NSCLC harboring MET exon 14 skipping alterations[4][5].

Pricing and Cost-Effectiveness

The wholesale acquisition cost (WAC) of Tepotinib is approximately $20,899 per month, which is significantly higher than its competitor, Capmatinib, priced at around $9,469 per month[1].

Despite the higher cost, Tepotinib has been found to be cost-effective under certain conditions. In frontline treatment settings, the incremental cost-effectiveness ratio (ICER) for Tepotinib is estimated at approximately $274,514 per quality-adjusted life year (QALY). In subsequent treatment lines, Tepotinib offers incremental QALYs and costs of 0.3330 and $91,401, respectively, indicating its value in these contexts[1].

Market Positioning

Tepotinib is positioned as a targeted therapy, which is preferentially used in the first-line setting for patients with MET exon 14 skipping alterations. This is due to its ability to improve overall survival (OS), progression-free survival (PFS), and response rate, while maintaining quality of life. If not used as first-line therapy, it is considered for second- or later-line treatment[4].

Clinical Efficacy

The VISION trial, a Phase 2 study, demonstrated the efficacy of Tepotinib. For patients with MET exon 14 skipping alterations who were not previously treated, 57% experienced at least a 50% shrinkage of their cancer, with disease control lasting a median of 46 months. For previously treated patients, the response rate was 45%, with many experiencing cancer control for more than 12 months[5].

Patient Demographics and Needs

Patients with MET exon 14 skipping alterations are typically older individuals, often 70 years or greater. Prior to Tepotinib, chemotherapy was the standard treatment, which often resulted in significant side effects. Tepotinib offers a well-tolerated oral treatment option, with leg swelling being the most common side effect[5].

Biomarker Testing and Liquid Biopsy

The approval of Tepotinib highlights the importance of biomarker testing to identify MET exon 14 skipping mutations in newly diagnosed lung cancer patients. The VISION trial also validated the use of liquid biopsy (blood sample) to detect these mutations, making the diagnostic process more accessible and less invasive[5].

Financial Impact and Reimbursement

The financial impact of Tepotinib is significant, given its high WAC. However, its cost-effectiveness in specific treatment lines justifies its use. Health Canada and other regulatory bodies have considered the reimbursement of Tepotinib based on its clinical benefits and the unmet need for targeted therapies in NSCLC patients with MET exon 14 skipping alterations[4].

Future Prospects and Research

Tepotinib is under development for various other cancers, including advanced gastric cancer, gastroesophageal junction carcinomas, and other solid tumors. Ongoing research involves testing Tepotinib and other MET inhibitors in different MET abnormalities, aiming to extend patient survival and improve treatment outcomes[3].

Competitive Landscape

In the competitive landscape of NSCLC treatments, Tepotinib competes with other MET inhibitors like Capmatinib. While Capmatinib is more cost-effective upfront, Tepotinib's superior cost-effectiveness in certain treatment settings gives it a strong market position[1].

Regulatory Pathways and Approvals

Tepotinib was approved through the FDA's expedited review process, and it has also received approval from Health Canada under the Project ORBIS pathway. These expedited approvals reflect the urgent need for effective treatments for NSCLC patients with MET exon 14 skipping alterations[4].

Clinical Expert Insights

Clinical experts emphasize the importance of Tepotinib as a targeted therapy that minimizes adverse events compared to traditional chemotherapy. The drug's ability to improve survival and maintain quality of life makes it a valuable addition to the treatment arsenal for NSCLC patients[4].

Patient Access and Affordability

Despite its high cost, Tepotinib's benefits in terms of improved survival and quality of life justify its use. However, patient access and affordability remain critical issues. Reimbursement policies and financial assistance programs are essential to ensure that patients can access this life-saving treatment[4].

Conclusion

Tepotinib hydrochloride has revolutionized the treatment of NSCLC with MET exon 14 skipping alterations, offering a targeted and well-tolerated oral therapy. While its high cost is a significant factor, its cost-effectiveness in specific treatment lines and its clinical efficacy make it a valuable option. Ongoing research and development in other cancer types further solidify its position in the market.

Key Takeaways

• FDA Approval: Tepotinib was approved by the FDA on February 3, 2021, for NSCLC with MET exon 14 skipping alterations.
• Pricing: The WAC of Tepotinib is approximately $20,899 per month.
• Cost-Effectiveness: Tepotinib is cost-effective in certain treatment lines, with an ICER of $274,514 per QALY in frontline settings.
• Clinical Efficacy: The VISION trial showed significant response rates and disease control in patients with MET exon 14 skipping alterations.
• Biomarker Testing: Biomarker testing, including liquid biopsy, is crucial for identifying eligible patients.
• Future Prospects: Ongoing research involves testing Tepotinib in other cancers and MET abnormalities.

FAQs

Q1: What is Tepotinib used for? Tepotinib is used for the treatment of adult patients with locally advanced unresectable or metastatic non-small cell lung cancer (NSCLC) harboring MET exon 14 skipping alterations.

Q2: How much does Tepotinib cost? The wholesale acquisition cost (WAC) of Tepotinib is approximately $20,899 per month.

Q3: Is Tepotinib cost-effective? Yes, Tepotinib is cost-effective in certain treatment lines, particularly in frontline settings, with an ICER of $274,514 per QALY.

Q4: What are the common side effects of Tepotinib? The most common side effect of Tepotinib is leg swelling.

Q5: Is Tepotinib available in other countries besides the U.S.? Yes, Tepotinib has been approved by Health Canada and is available in other countries through various regulatory pathways.

Sources

1. DelveInsight: Biomarkers in Non-Small Cell Lung Cancer Therapy Market
2. Oregon Drug Use Review / Pharmacy & Therapeutics Committee: Meeting Docs
3. GlobalData: Net Present Value Model: Tepmetko
4. Canada's Drug Agency: Tepotinib (Tepmetko)
5. Lung Cancer Research Foundation: Tepotinib approved for MET exon 14