CAPMATINIB HYDROCHLORIDE - Generic Drug Details

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

Capmatinib hydrochloride is the generic ingredient in one branded drug marketed by Novartis Pharm and is included in one NDA. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Capmatinib hydrochloride has one hundred and seventy-eight patent family members in forty-five countries.

One supplier is listed for this compound.

Summary for CAPMATINIB HYDROCHLORIDE

International Patents:	178
US Patents:	6
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	25
DailyMed Link:	CAPMATINIB HYDROCHLORIDE at DailyMed

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

Constraining patent/regulatory exclusivity:

10,596,178

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 CAPMATINIB HYDROCHLORIDE

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

Sponsor	Phase
Sun Yat-sen University	Phase 2
Yonsei University	Phase 2
Southwest Oncology Group	Phase 2

See all CAPMATINIB HYDROCHLORIDE clinical trials

Pharmacology for CAPMATINIB HYDROCHLORIDE

Drug Class	Kinase Inhibitor
Mechanism of Action	Breast Cancer Resistance Protein Inhibitors Cytochrome P450 1A2 Inhibitors Mesenchymal Epithelial Transition Inhibitors Multidrug and Toxin Extrusion Transporter 1 Inhibitors Multidrug and Toxin Extrusion Transporter 2 K Inhibitors P-Glycoprotein Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for CAPMATINIB HYDROCHLORIDE

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

Paragraph IV (Patent) Challenges for CAPMATINIB HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TABRECTA	Tablets	capmatinib hydrochloride	150 mg and 200 mg	213591	1	2024-05-06

US Patents and Regulatory Information for CAPMATINIB HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis Pharm	TABRECTA	capmatinib hydrochloride	TABLET;ORAL	213591-002	May 6, 2020		RX	Yes	Yes
Novartis Pharm	TABRECTA	capmatinib hydrochloride	TABLET;ORAL	213591-002	May 6, 2020		RX	Yes	Yes	8,461,330		Y	Y
Novartis Pharm	TABRECTA	capmatinib hydrochloride	TABLET;ORAL	213591-001	May 6, 2020		RX	Yes	No	10,596,178		Y	Y
Novartis Pharm	TABRECTA	capmatinib hydrochloride	TABLET;ORAL	213591-002	May 6, 2020		RX	Yes	Yes	8,420,645		Y	Y
Novartis Pharm	TABRECTA	capmatinib hydrochloride	TABLET;ORAL	213591-001	May 6, 2020		RX	Yes	No	8,461,330		Y	Y

International Patents for CAPMATINIB HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
Norway	20190709	Imidazotriaziner og imidazopyrimidiner som kinaseinhibitorer
Eurasian Patent Organization	201790259	СОСТАВ ТАБЛЕТОК 2-ФТОР-N-МЕТИЛ-4-[7-(ХИНОЛИН-6-ИЛМЕТИЛ)ИМИДАЗО[1,2-b][1,2,4]ТРИАЗИН-2-ИЛ]БЕНЗАМИДА
Serbia	54510	IMIDAZOTRIAZINI I IMIDAZOPIRIMIDINI KAO INHIBITORI KINAZE (IMIDAZOTRIAZINES AND IMIDAZOPYRIMIDINES AS KINASE INHIBITORS)
Japan	2011520976
Israel	198716	אימידזוטריאזינים ואימידזופירימידינים כמעכבי קינאז (Imidazotriazines and imidazopyrimidines as kinase inhibitors)

Supplementary Protection Certificates for CAPMATINIB HYDROCHLORIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3172209	22C1058	France		PRODUCT NAME: CAPMATINIB OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, EN PARTICULIER LE SEL DE DICHLORHYDRATE; REGISTRATION NO/DATE: EU/1/22/1650 20220621
2099447	CR 2022 00053	Denmark		PRODUCT NAME: CAPMATINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/22/1650 20220621
2099447	PA2022527	Lithuania		PRODUCT NAME: KAPMATINIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/22/1650 20220620
3172209	51/2022	Austria		PRODUCT NAME: CAPMATINIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/22/1650 (MITTEILUNG) 20220621
3172209	C202230060	Spain		PRODUCT NAME: CAPMATINIB O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/22/1650; DATE OF AUTHORISATION: 20220620; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/22/1650; DATE OF FIRST AUTHORISATION IN EEA: 20220620

CAPMATINIB HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Capmatinib Hydrochloride

Introduction

Capmatinib hydrochloride, marketed under the brand name Tabrecta, is a significant advancement in the treatment of metastatic non-small cell lung cancer (mNSCLC) with a specific MET exon 14 (METex14) skipping mutation. This article delves into the market dynamics and financial trajectory of this drug, highlighting its impact on patients, pharmaceutical companies, and investors.

Clinical Significance and Approval

Capmatinib hydrochloride is a small molecule drug that targets the c-Met protein, crucial for cell growth and survival. It has been approved globally for the treatment of mNSCLC with METex14 skipping mutations, a condition that is aggressive and challenging to treat[4].

Market Uptake and Patient Eligibility

The market uptake of capmatinib is influenced by several factors, including the number of eligible patients and the testing rates for the METex14 mutation. Studies estimate that in a hypothetical 1 million member commercial health plan, 2-3 patients per year would be eligible for capmatinib, while in a Medicare plan, this number increases to 34-44 patients per year[1].

Budget Impact and Cost Analysis

The inclusion of capmatinib in health plans has a minimal budget impact. For commercial plans, the estimated total budget impact ranges from $9,695 to $67,725, while for Medicare plans, it ranges from $141,350 to $985,695. The marginal per member per month budget impact is relatively low, estimated at $0.0008 to $0.0056 for commercial plans and $0.0118 to $0.0821 for Medicare plans. Notably, the increased drug costs are partially offset by savings in adverse event, progression-related, and terminal care costs[1].

Generic Version and Market Exclusivity

Natco Pharma's recent move to submit an Abbreviated New Drug Application (ANDA) for a generic version of capmatinib hydrochloride is significant. If approved, Natco could gain 180 days of sole marketing exclusivity, which would be a game-changer in the US oncology market. This exclusivity period could result in substantial revenue, given that the branded version, Tabrecta, recorded sales of $126 million in 2023 alone[2].

Financial Implications for Natco Pharma

Natco Pharma's strategy to challenge patents and bring generic versions of complex drugs to market positions it for sustained growth. The potential approval and market exclusivity for the generic version of capmatinib hydrochloride could significantly boost Natco's financial performance in the 2024-25 fiscal year. This move has already reflected positively in the stock market, with Natco's shares jumping nearly 5% following the announcement[2].

Revenue and Stock Performance

Natco Pharma has been on a growth trajectory, with its stock gaining nearly 90% year-to-date and over 150% in the past two years. The potential revenue from the new generic drug could further enhance this performance, making Natco a strong contender in the pharmaceutical market. However, investors must consider the risks involved, including the lengthy and uncertain approval process and potential legal challenges from Novartis[2].

Market Competition and Strategy

Natco Pharma's focus on high-margin, niche products, particularly in the oncology segment, helps it differentiate from competitors. By targeting a niche product like capmatinib hydrochloride, Natco is positioning itself to tap into a lucrative market with less competition. This strategy aligns with Natco's overall approach of identifying and capitalizing on market opportunities[2].

Clinical Trials and R&D Progress

The clinical trials for capmatinib hydrochloride have demonstrated its potential therapeutic benefits, particularly at the 2023 ESMO Congress. The drug has reached the highest phase of development and is approved globally, with clinical trial areas primarily in the United States, China, and the United Kingdom[4].

Sensitivity Analysis

The budget impact of capmatinib is most sensitive to its market share, price, and treatment duration. These factors significantly influence the overall cost and savings associated with the drug's inclusion in health plans[1].

Conclusion

Capmatinib hydrochloride is a critical drug in the treatment of mNSCLC with METex14 skipping mutations. Its market dynamics are shaped by factors such as patient eligibility, testing rates, and the presence of generic versions. The financial trajectory for this drug is promising, especially for companies like Natco Pharma that are poised to capitalize on market exclusivity and high demand.

Key Takeaways

• Minimal Budget Impact: The inclusion of capmatinib in health plans has a minimal budget impact, with costs partially offset by savings in other medical areas.
• Generic Version: Natco Pharma's generic version could gain significant market share and revenue due to 180 days of sole marketing exclusivity.
• Financial Growth: Natco Pharma's strategy positions it for substantial financial gains in the 2024-25 fiscal year.
• Clinical Significance: Capmatinib hydrochloride has demonstrated strong therapeutic benefits in clinical trials.
• Market Competition: Natco Pharma's focus on niche products helps it differentiate and capitalize on market opportunities.

FAQs

Q: What is capmatinib hydrochloride used for? A: Capmatinib hydrochloride is used to treat adults with metastatic non-small cell lung cancer (mNSCLC) who have a specific MET exon 14 (METex14) skipping mutation.

Q: How does the generic version of capmatinib hydrochloride impact Natco Pharma? A: The generic version could grant Natco Pharma 180 days of sole marketing exclusivity, leading to significant revenue and financial growth.

Q: What are the key factors influencing the budget impact of capmatinib? A: The budget impact is most sensitive to capmatinib's market share, price, and treatment duration.

Q: How does capmatinib hydrochloride affect healthcare costs? A: The increased drug costs are partially offset by savings in adverse event, progression-related, and terminal care costs.

Q: What is the current market status of capmatinib hydrochloride? A: Capmatinib hydrochloride is approved globally and has reached the highest phase of development, with ongoing clinical trials in several countries.

Sources

1. PubMed: "Budget impact of capmatinib for adults with metastatic non-small cell lung cancer..."
2. StockGro: "Natco Pharma's New Generic Cancer Drug: Impact on FY 2024-25"
3. Chugai Pharma: "Q2 Results (Jan - Jun 2021) Conference Call"
4. Patsnap Synapse: "Brief Review of Capmatinib Hydrochloride's R&D Progress and Clinical Results in 2023 ESMO"