CARNEXIV Drug Patent Profile

When do Carnexiv patents expire, and what generic alternatives are available?

Carnexiv is a drug marketed by Lundbeck Pharms Llc and is included in one NDA. There are seven patents protecting this drug.

This drug has seventy-seven patent family members in twenty-one countries.

The generic ingredient in CARNEXIV is carbamazepine. There are twenty-seven drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the carbamazepine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Carnexiv

A generic version of CARNEXIV was approved as carbamazepine by TARO on October 3^rd, 1996.

Summary for CARNEXIV

International Patents:	77
US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	163
Patent Applications:	4,301
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CARNEXIV
What excipients (inactive ingredients) are in CARNEXIV?	CARNEXIV excipients list
DailyMed Link:	CARNEXIV at DailyMed

Pharmacology for CARNEXIV

Drug Class	Mood Stabilizer
Mechanism of Action	Cytochrome P450 1A2 Inducers Cytochrome P450 2B6 Inducers Cytochrome P450 2C19 Inducers Cytochrome P450 2C9 Inducers Cytochrome P450 3A4 Inducers
Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity

US Patents and Regulatory Information for CARNEXIV

CARNEXIV is protected by nine US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Lundbeck Pharms Llc	CARNEXIV	carbamazepine	SOLUTION;INTRAVENOUS	206030-001	Oct 7, 2016		DISCN	Yes	No	9,629,797
Lundbeck Pharms Llc	CARNEXIV	carbamazepine	SOLUTION;INTRAVENOUS	206030-001	Oct 7, 2016		DISCN	Yes	No	9,770,407		Y
Lundbeck Pharms Llc	CARNEXIV	carbamazepine	SOLUTION;INTRAVENOUS	206030-001	Oct 7, 2016		DISCN	Yes	No	9,493,582		Y
Lundbeck Pharms Llc	CARNEXIV	carbamazepine	SOLUTION;INTRAVENOUS	206030-001	Oct 7, 2016		DISCN	Yes	No	8,410,077		Y
Lundbeck Pharms Llc	CARNEXIV	carbamazepine	SOLUTION;INTRAVENOUS	206030-001	Oct 7, 2016		DISCN	Yes	No	9,750,822		Y

International Patents for CARNEXIV

See the table below for patents covering CARNEXIV around the world.

Country	Patent Number	Title	Estimated Expiration
Russian Federation	2014136206	КОМПОЗИЦИИ АЛКИЛИРОВАННОГО ЦИКЛОДЕКСТРИНА И СПОСОБЫ ИХ ПОЛУЧЕНИЯ И ПРИМЕНЕНИЯ
Mexico	352459	COMPOSICIONES DE ETER-SULFOALQUILICO-CICLODEXTRINA. (SULFOALKYL ETHER CYCLODEXTRIN COMPOSITIONS.)
Russian Federation	2615385	КОМПОЗИЦИИ АЛКИЛИРОВАННОГО ЦИКЛОДЕКСТРИНА И СПОСОБЫ ИХ ПОЛУЧЕНИЯ И ПРИМЕНЕНИЯ (ALKYLATED CYCLODEXTRIN COMPOSITIONS AND PROCESSES FOR PREPARING AND USING THE SAME RELATED APPLICATIONS)
Russian Federation	2455996	НОВАЯ ПАРЕНТЕРАЛЬНАЯ КОМПОЗИЦИЯ КАРБАМАЗЕПИНА (NEW PARENTERAL CARMABAZEPINE COMPOSITION)
Hong Kong	1211311	烷基化環糊精組合物及其製備和使用方法 (ALKYLATED CYCLODEXTRIN COMPOSITIONS AND PROCESSES FOR PREPARING AND USING THE SAME)

CARNEXIV Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Carnexiv

Introduction to Carnexiv

Carnexiv, developed by Lundbeck, is an intravenous formulation of the antiepileptic drug (AED) carbamazepine. It was approved by the US FDA as a short-term replacement therapy for oral carbamazepine formulations in adults with certain seizure types when oral administration is temporarily not feasible[1].

Clinical Indications and Usage

Carnexiv is indicated for the treatment of partial seizures with complex symptomatology and generalized tonic-clonic seizures in adults. It is designed to provide continuity of care for patients who are unable to take oral carbamazepine due to various reasons. The intravenous administration of Carnexiv involves dividing the total daily dosage into four separate 30-minute infusions, with each infusion separated by 6 hours. The dosage should be 70% of the total daily dose of oral carbamazepine[1].

Development and Approval Process

The development of Carnexiv involved significant collaboration between Lundbeck and researchers at the University of Minnesota College of Pharmacy. Early clinical proof-of-concept studies conducted by James Cloyd, PharmD, Angela Birnbaum, PhD, and Ilo E. Leppik, MD, were instrumental in making intravenous administration of carbamazepine possible. Carnexiv received orphan drug designation for its specific indication and was approved by the FDA in 2016[1].

Market Position in Epilepsy Therapeutics

The global epilepsy therapeutics market is expected to grow to $7.5 billion by 2026, driven by the launch of late-stage pipeline products. While Carnexiv is not one of the top-selling pipeline drugs, it fills a critical niche as the first available intravenous formulation of carbamazepine, addressing a specific need in the epilepsy treatment landscape[4].

Financial Impact on Lundbeck

The approval of Carnexiv contributed to Lundbeck's financial performance in 2016. Lundbeck's total revenue for 2016 reached DKK 15,634 million, with a significant increase in US revenue driven by the uptake of several key products, including Carnexiv. The approval of Carnexiv also led to a milestone payment of $1.25 million to Ligand Pharmaceuticals, which partnered with Lundbeck on the drug[1][2].

Royalty Structure and Revenue Projections

Ligand Pharmaceuticals, which has a royalty agreement with Lundbeck for Carnexiv, is entitled to receive a royalty of 2.75% on the net sales of Carnexiv. This royalty structure is part of Ligand's broader portfolio of royalty-generating assets, which are expected to drive significant revenue growth. Ligand's royalty revenue is projected to grow substantially over the next few years, with Carnexiv contributing to this growth, although it is not expected to be one of the largest contributors compared to other products like Kyprolis and Evomela[1][3].

Competitive Landscape

In the epilepsy therapeutics market, Carnexiv competes with other AEDs such as Aptiom/Zebinix (eslicarbazepine acetate), Briviact (brivaracetam), Fycompa (perampanel), Keppra (levetiracetam), and Lamictal (lamotrigine). However, its unique intravenous formulation sets it apart, catering to a specific patient population that cannot take oral medications temporarily[4].

Future Outlook and Growth Potential

Lundbeck's financial outlook for subsequent years includes continued growth driven by key products, including those in the epilepsy segment. While Carnexiv is not expected to be a blockbuster drug, it contributes to the overall growth and diversification of Lundbeck's product portfolio. The company's strategy to improve profitability and value creation is likely to benefit from the commercial success of Carnexiv and other products[2].

Key Challenges and Opportunities

One of the key challenges for Carnexiv is the limited duration of its use (≤7 days), which restricts its long-term revenue potential. However, its orphan drug designation and the lack of other intravenous carbamazepine formulations provide a unique market opportunity. The drug's success also depends on its integration into clinical practice guidelines and its acceptance by healthcare providers[1].

Regulatory and Safety Considerations

Carnexiv comes with a boxed warning for serious dermatologic reactions and aplastic anemia and agranulocytosis. These safety considerations are crucial for its prescribing information and patient monitoring. Ensuring compliance with regulatory requirements and maintaining a strong safety profile will be essential for its continued market presence[1].

Partnerships and Collaborations

The development and commercialization of Carnexiv highlight the importance of partnerships in the pharmaceutical industry. The collaboration between Lundbeck, Ligand Pharmaceuticals, and researchers at the University of Minnesota demonstrates how such partnerships can lead to innovative treatments and mutual financial benefits[1].

Financial Performance and Projections

Lundbeck's financial performance in 2016 was positively impacted by the approval of Carnexiv, among other factors. The company's revenue and operating profit increased significantly, setting a strong foundation for future growth. For 2017, Lundbeck forecasted revenue to be between DKK 16.3-17.1 billion, with EBIT expected to be between DKK 3.4-3.8 billion[2].

Conclusion

Carnexiv represents a significant advancement in the treatment of epilepsy, particularly for patients who cannot take oral medications. Its unique intravenous formulation and specific indications position it well in the market, despite its limited use duration. The financial trajectory for Carnexiv is tied to the broader success of Lundbeck and Ligand Pharmaceuticals, with both companies expecting continued growth from their respective portfolios.

Key Takeaways

• Unique Formulation: Carnexiv is the first intravenous formulation of carbamazepine, addressing a critical need for patients unable to take oral medications.
• Market Niche: It fills a specific niche in the epilepsy therapeutics market, contributing to the overall growth of Lundbeck and Ligand Pharmaceuticals.
• Financial Impact: The approval of Carnexiv contributed to the financial performance of both Lundbeck and Ligand Pharmaceuticals in 2016.
• Safety Considerations: It comes with a boxed warning for serious dermatologic reactions and hematologic adverse effects.
• Partnerships: The development of Carnexiv highlights the importance of partnerships in bringing innovative treatments to market.

FAQs

Q: What is Carnexiv used for? A: Carnexiv is an intravenous antiepileptic drug used as a short-term replacement therapy for oral carbamazepine formulations in adults with certain seizure types when oral administration is temporarily not feasible.

Q: Who developed Carnexiv? A: Carnexiv was developed by Lundbeck in collaboration with researchers at the University of Minnesota College of Pharmacy.

Q: What is the royalty structure for Carnexiv? A: Ligand Pharmaceuticals is entitled to a royalty of 2.75% on the net sales of Carnexiv.

Q: What are the key safety considerations for Carnexiv? A: Carnexiv comes with a boxed warning for serious dermatologic reactions and aplastic anemia and agranulocytosis.

Q: How does Carnexiv fit into the broader epilepsy therapeutics market? A: Carnexiv fills a specific niche as the first available intravenous formulation of carbamazepine, addressing a critical need for patients who cannot take oral medications temporarily.

Cited Sources

1. Ligand Partners Spectrum Pharmaceuticals & Lundbeck Receive FDA Approvals - Drug Development.
2. Lundbeck Annual Report 2016 - Lundbeck.
3. 2023 Investor Day - Ligand Pharmaceuticals.
4. Epilepsy – Global Drug Forecast and Market Analysis to 2026 - GlobalData.