Inotersen sodium - Generic Drug Details

What are the generic sources for inotersen sodium and what is the scope of freedom to operate?

Inotersen sodium is the generic ingredient in one branded drug marketed by Akcea Theraps and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Inotersen sodium has thirty-four patent family members in twenty-four countries.

One supplier is listed for this compound.

Summary for inotersen sodium

International Patents:	34
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
DailyMed Link:	inotersen sodium at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for inotersen sodium

Constraining patent/regulatory exclusivity:

8,697,860

Dosage:

SOLUTION;SUBCUTANEOUS

^*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.

Pharmacology for inotersen sodium

Drug Class	Antisense Oligonucleotide Transthyretin-directed RNA Interaction
Physiological Effect	Decreased RNA Integrity Increased Protein Breakdown

Anatomical Therapeutic Chemical (ATC) Classes for inotersen sodium

N07XX	Other nervous system drugs
N07X	OTHER NERVOUS SYSTEM DRUGS
N07	OTHER NERVOUS SYSTEM DRUGS
N	Nervous system

US Patents and Regulatory Information for inotersen sodium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Akcea Theraps	TEGSEDI	inotersen sodium	SOLUTION;SUBCUTANEOUS	211172-001	Oct 5, 2018		DISCN	Yes	No	9,061,044			Y
Akcea Theraps	TEGSEDI	inotersen sodium	SOLUTION;SUBCUTANEOUS	211172-001	Oct 5, 2018		DISCN	Yes	No	8,101,743		Y	Y
Akcea Theraps	TEGSEDI	inotersen sodium	SOLUTION;SUBCUTANEOUS	211172-001	Oct 5, 2018		DISCN	Yes	No	9,399,774
Akcea Theraps	TEGSEDI	inotersen sodium	SOLUTION;SUBCUTANEOUS	211172-001	Oct 5, 2018		DISCN	Yes	No
Akcea Theraps	TEGSEDI	inotersen sodium	SOLUTION;SUBCUTANEOUS	211172-001	Oct 5, 2018		DISCN	Yes	No	8,697,860		Y

Expired US Patents for inotersen sodium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Akcea Theraps	TEGSEDI	inotersen sodium	SOLUTION;SUBCUTANEOUS	211172-001	Oct 5, 2018	7,015,315
Akcea Theraps	TEGSEDI	inotersen sodium	SOLUTION;SUBCUTANEOUS	211172-001	Oct 5, 2018	7,101,993

International Patents for inotersen sodium

Country	Patent Number	Title	Estimated Expiration
China	103038345	Modulation of transthyretin expression
Israel	222697	איפנון הביטוי של טרנסתירטין (Modulation of transthyretin expression)
Netherlands	300963
Mexico	2012012624	MODULACION DE LA EXPRESION DE TRANSTIRETINA. (MODULATION OF TRANSTHYRETIN EXPRESSION.)
Canada	2797792	MODULATION DE L'EXPRESSION DE LA TRANSTHYRETINE (MODULATION OF TRANSTHYRETIN EXPRESSION)
South Korea	101835386

Supplementary Protection Certificates for inotersen sodium

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2563920	LUC00096	Luxembourg		PRODUCT NAME: INOTERSEN AND SALTS THEREOF; AUTHORISATION NUMBER AND DATE: EU/1/18/1296 20180710
2563920	CR 2019 00001	Denmark		PRODUCT NAME: INOTERSEN AND SALT THEREOF, INCLUDING SODIUM SALTS; REG. NO/DATE: EU/1/18/1296 20180710
2563920	PA2019001,C2563920	Lithuania		PRODUCT NAME: INOTERSENAS IR JO DRUSKOS; REGISTRATION NO/DATE: EU/1/18/1296 20180706
2563920	CA 2019 00001	Denmark		PRODUCT NAME: A COMPOUND COMPRISING A MODIFIED OLIGONUCLEOTIDE HAVING A NUCLEOBASE SEQUENCE CONSISTING OF 20 LINKED NUCLEOSIDES ACCORDING TO EP B1 2563920 CLAIM 1 (SEQ ID NO: 80), ...SPECIFICALLY INOTERSEN; AND ITS DERIVATIVES, INCLUDING SODIUM SALTS ...; REG. NO/DATE: EU/1/18/1296 20180710
2563920	122019000001	Germany		PRODUCT NAME: VERBINDUNG, UMFASSEND EIN MODIFIZIERTES OLIGONUKLEOTID MIT EINER NUKLEOBASENSEQUENZ BESTEHEND AUS 20 VERKNUEPFTEN NUKLEOSIDEN GEMAESS EP B1 2563920, ANSPRUCH 1 (SEQ ID NO: 80), WOBEI DAS MODIFIZIERTE OLIGONUKLEOTID UMFASST: EIN LUECKENSEGMENT, DAS AUS ZEHN VERKNUEPFTEN DESOXYNUKLEOSIDEN BESTEHT ; EIN 5'-FLUEGELSEGMENT BESTEHEND AUS FUENF VERKNUEPFTEN NUKLEOSIDEN; UND EIN 3'-FLUEGELSEGMENT BESTEHEND AUS FUEN; REGISTRATION NO/DATE: EU/1/18/1296 20180706
2563920	2019001	Norway		PRODUCT NAME: FORBINDELSE OMFATTENDE ET MODIFISERT OLIGONUKLEOTID SOM HAR EN NUKLEOBASESEKVENS BESTAENDE AV 20 KOBLEDE NUKLEOSIDER IFOELGE EP B1 2563920 KRAV 1 (SEQ ID NO: 80), HVOR DET MODIFISERTE OLIGONUKLEOTIDET OMFATTER: ET AVSTANDSSEGMENT BESTAENDE AV TI KOBLEDE DEOKSYNUKLEOSIDER; ET 5'- VINGESEGMENT BESTAENDE AV FEM KOBLEDE NUKLEOSIDER; OG ET 3'-VINGESEGMENT BESTAENDE AV FEM KOBLEDE NUKLEOSIDER; HVOR AVSTANDSSEGMENTET ER PLASSERT MELLOM 5'- VINGESEGMENTET OG 3'- VINGESEGMENTET, HVOR HVERT NUKLEOSID AV HVERT VINGESEGMENT OMFATTER ET 2'- 0-METOKSYETYLSUKKER; HVOR HVER CYTOSIN AV DET MODIFISERTE OLIGONUKLEOTID ER EN 5-METYLCYTOSIN, OG HVOR HVER INTERNUKLEOSID-BINDING AV DET MODIFISERTE OL

Inotersen sodium Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Inotersen Sodium

Introduction to Inotersen Sodium

Inotersen sodium, marketed as Tegsedi, is an antisense oligonucleotide indicated for the treatment of polyneuropathy in adult patients with hereditary transthyretin-mediated amyloidosis (hATTR)[4][5].

Market Size and Growth

The global transthyretin amyloidosis treatment market, which includes inotersen, has been experiencing significant growth. In 2018, the market size was valued at US$ 35.8 million and is expected to witness a robust Compound Annual Growth Rate (CAGR) of 55.4% over the forecast period from 2018 to 2026[3].

Regulatory Approvals and Market Access

Inotersen received marketing authorization from the European Commission in July 2018 for the treatment of stage 1 or stage 2 polyneuropathy in adult patients with hereditary transthyretin amyloidosis. It also gained approval from the U.S. FDA in 2018[3][5].

Competitive Landscape

The market for transthyretin amyloidosis treatments is highly competitive, with several other drugs available or in late-stage clinical trials. Key competitors include patisiran (ONPATTRO) by Alnylam Pharmaceuticals and eplontersen (Wainua) by AstraZeneca and Ionis Pharmaceuticals[2][3].

Cost and Cost-Effectiveness

Inotersen is a high-cost drug, with an annual cost of approximately US$ 450,000 before insurance. This high cost is a significant barrier to adoption, even in developed economies. Pharmacoeconomic analyses have shown that inotersen is more costly than best supportive care (BSC), with an incremental cost-utility ratio (ICUR) of $523,448 per QALY gained in the manufacturer's base case analysis. However, reanalyses by CADTH estimated the ICUR to be $1,322,377 per QALY, indicating that a price reduction of at least 88% would be required for inotersen to be considered cost-effective at a $50,000 per QALY threshold[1].

Revenue and Sales Projections

Despite the high cost, inotersen generates significant revenue due to its niche market and the severe nature of the condition it treats. The revenue is expected to grow as more patients are diagnosed and treated, and as the drug becomes more widely accepted and reimbursed by healthcare systems.

Challenges and Limitations

Several challenges affect the financial trajectory of inotersen:

• High Costs: The drug's high price hinders adoption and affects its cost-effectiveness.
• Pharmacoeconomic Limitations: Uncertainties in the model structure and disease progression modeling have raised concerns about the accuracy of cost-utility analyses[1].
• Regulatory and Reimbursement Issues: The drug's approval and reimbursement processes can be complex and vary by region, impacting its market access and revenue.

Strategic Partnerships and Distribution

To enhance market share and distribution, companies like Ionis Pharmaceuticals and Akcea Therapeutics have formed strategic partnerships. For example, Alnylam Pharmaceuticals partnered with Orsini Healthcare, a specialty pharmacy, to distribute ONPATTRO, a similar drug in the same therapeutic area[3].

Pipeline and Future Developments

The robust pipeline of transthyretin amyloidosis treatment drugs, including AG10 by Eidos Therapeutics and AKCEA-TTR-LRx by Akcea Therapeutics and Ionis Pharmaceuticals, suggests that the market will continue to evolve. These new treatments could potentially impact the market share and pricing dynamics of existing drugs like inotersen[3].

Patient and Healthcare System Impact

Inotersen has shown significant clinical benefits, including a reduction in serum TTR levels and improvement in neuropathy impairment and quality of life. However, the high cost and limited cost-effectiveness pose challenges for healthcare systems and patients, highlighting the need for careful consideration in treatment decisions and reimbursement policies[4][5].

Key Takeaways

• Market Growth: The transthyretin amyloidosis treatment market is growing rapidly.
• High Cost: Inotersen is expensive, with significant annual costs.
• Cost-Effectiveness: The drug's cost-effectiveness is a major concern, requiring substantial price reductions to meet common thresholds.
• Competitive Landscape: The market is competitive, with several other treatments available or in development.
• Regulatory and Reimbursement Challenges: Approval and reimbursement processes are complex and can vary by region.

FAQs

Q: What is inotersen sodium used for? A: Inotersen sodium, marketed as Tegsedi, is used to treat polyneuropathy in adult patients with hereditary transthyretin-mediated amyloidosis (hATTR)[4].

Q: How much does inotersen sodium cost? A: The annual cost of inotersen sodium is approximately US$ 450,000 before insurance[3].

Q: What are the key challenges in the market for inotersen sodium? A: High costs, pharmacoeconomic limitations, and regulatory and reimbursement issues are significant challenges[1][3].

Q: Are there other treatments available for hereditary transthyretin-mediated amyloidosis? A: Yes, other treatments include patisiran (ONPATTRO) and eplontersen (Wainua), with several more in late-stage clinical trials[2][3].

Q: How does inotersen sodium affect serum TTR levels? A: Inotersen sodium reduces serum TTR levels by 68% to 74% from baseline with repeat dosing[4].

Cited Sources

1. CDR Pharmacoeconomic Review Report for Tegsedi - CADTH
2. Wainua (eplontersen) granted first-ever regulatory approval in the US - AstraZeneca
3. Transthyretin Amyloidosis Treatment Market Size & Share Analysis - Coherent Market Insights
4. Inotersen: Uses, Interactions, Mechanism of Action - DrugBank Online
5. Tegsedi's (inotersen) proposed indication - FDA Drugs@FDA