SYMJEPI Drug Patent Profile

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

Symjepi is a drug marketed by Adamis Pharms Corp and is included in one NDA. There is one patent protecting this drug.

This drug has thirty-two patent family members in seventeen countries.

The generic ingredient in SYMJEPI is epinephrine. There are twenty-one drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the epinephrine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Symjepi

A generic version of SYMJEPI was approved as epinephrine by BPI LABS on July 29^th, 2014.

Summary for SYMJEPI

International Patents:	32
US Patents:	1
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	88
Patent Applications:	1,165
Drug Prices:	Drug price information for SYMJEPI
What excipients (inactive ingredients) are in SYMJEPI?	SYMJEPI excipients list
DailyMed Link:	SYMJEPI at DailyMed

See drug prices for SYMJEPI

US Patents and Regulatory Information for SYMJEPI

SYMJEPI is protected by one US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Adamis Pharms Corp	SYMJEPI	epinephrine	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	207534-002	Sep 27, 2018		DISCN	Yes	No			Y
Adamis Pharms Corp	SYMJEPI	epinephrine	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	207534-001	Jun 15, 2017		RX	Yes	Yes			Y

International Patents for SYMJEPI

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

Country	Patent Number	Title	Estimated Expiration
Brazil	112018003461	dispositivo de seringa, e método para administrar uma dose terapêutica de pelo menos um medicamento
Israel	257642	התקנים מסוג מזרק (Syringe devices)
Russian Federation	2710493	ШПРИЦЕВЫЕ УСТРОЙСТВА (SYRINGE DEVICES)
Portugal	3341056
Japan	6753926

SYMJEPI Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for SYMJEPI

Introduction to SYMJEPI

SYMJEPI, developed by Adamis Pharmaceuticals, is an epinephrine injection product designed to treat severe allergic reactions, including anaphylaxis. It is available in two doses: 0.3mg and 0.15mg, catering to different patient needs.

Market Position and Growth Prospects

The epinephrine autoinjector market, in which SYMJEPI operates, is poised for significant growth. The market is expected to grow at a CAGR of 8.5% by 2027, driven by favorable reimbursement policies and increasing demand for emergency allergy treatments[1].

Competitive Landscape

SYMJEPI enters a competitive market dominated by established players, but it offers a unique alternative. The product is promoted by US WorldMeds through its field sales force, which has been crucial in reaching high-prescribing allergists and primary care physicians. This strategic partnership is expected to enhance the product's market presence and sales[4].

Financial Performance of Adamis Pharmaceuticals

Revenue Trends

Despite the potential of SYMJEPI, Adamis Pharmaceuticals has faced challenges in recent years. In the third quarter of 2022, the company reported total net revenue of approximately $1.5 million, a significant increase from $760,000 in the third quarter of 2021. However, this growth was partly offset by the absence of SYMJEPI sales due to a product recall in March 2022[2].

For the full year 2021, net revenues from continuing operations were $2.2 million, down from $2.8 million in 2020. This decline was largely due to a $2.0 million reserve related to the SYMJEPI recall[5].

Operating Expenses

Adamis Pharmaceuticals has made efforts to reduce operating expenses. In the third quarter of 2022, selling, general, and administrative expenses decreased by 52% compared to the same period in 2021, primarily due to lower development spending and reduced legal and advisory fees[2].

Net Loss

The company reported a net loss of approximately $4.4 million in the third quarter of 2022, a 64% decrease from the $12.4 million net loss in the third quarter of 2021. This improvement is a positive sign, but the company still faces financial challenges[2].

Impact of the SYMJEPI Recall

Voluntary Recall

In March 2022, Adamis Pharmaceuticals announced a voluntary recall of certain lots of SYMJEPI due to quality control issues. This recall had a significant impact on the company's financials, leading to a $2.0 million reserve reduction in revenue for 2021. The recall also affected the product's commercial availability and sales momentum[5].

Recovery and Future Plans

The company is exploring the possibility of recovering some or all of the recall costs from third parties under their manufacturing agreements. However, the exact amount and timing of any recovery are uncertain. Despite this setback, Adamis and its partner US WorldMeds are committed to relaunching SYMJEPI and ensuring its commercial availability[5].

Strategic Partnerships and Distribution

Partnership with US WorldMeds

The partnership with US WorldMeds has been a critical factor in the commercial strategy for SYMJEPI. US WorldMeds began promoting the product through its field sales force in July 2020, following the termination of the distribution agreement with Sandoz Inc. This transition aimed to minimize market disruption and leverage US WorldMeds' commercial infrastructure to boost sales[4].

Transition Services Agreement

Adamis entered into a transition services agreement with Sandoz and US WorldMeds to ensure a smooth transfer of commercial rights for SYMJEPI. This agreement helps in maintaining continuity for patients and customers during the transition period[4].

Market Challenges and Opportunities

Regulatory Constraints

The epinephrine autoinjector market, including SYMJEPI, faces regulatory constraints that can impede growth. Compliance with FDA regulations and managing recalls effectively are crucial for maintaining market trust and ensuring product safety[1].

Cost and Affordability

The high cost of epinephrine autoinjectors is another significant challenge. Despite the critical need for these devices, affordability remains a barrier for many patients. Favorable reimbursement policies can help mitigate this issue, but it remains a key challenge for market growth[1].

Future Outlook

Relaunch and Commercial Availability

Adamis Pharmaceuticals and its partners are working towards the relaunch of SYMJEPI, with commercial availability anticipated before the end of the first quarter of 2023. This relaunch is expected to revive sales and help the company regain its market position[1].

Market Expansion

The Asia-Pacific region is identified as the fastest-growing market for epinephrine autoinjectors, offering significant expansion opportunities for SYMJEPI. North America remains the largest market, but the growing demand in other regions presents a promising future for the product[1].

Key Takeaways

• Market Growth: The epinephrine autoinjector market is expected to grow at a CAGR of 8.5% by 2027.
• Financial Challenges: Adamis Pharmaceuticals faced financial setbacks due to the SYMJEPI recall, but has seen improvements in revenue and reduced operating expenses.
• Strategic Partnerships: The partnership with US WorldMeds is crucial for the commercial success of SYMJEPI.
• Regulatory and Cost Challenges: The market faces regulatory constraints and high product costs, which need to be addressed.
• Future Outlook: The relaunch of SYMJEPI and expansion into growing markets offer promising opportunities.

FAQs

What is SYMJEPI?

SYMJEPI is an epinephrine injection product developed by Adamis Pharmaceuticals to treat severe allergic reactions, including anaphylaxis.

Why was SYMJEPI recalled?

SYMJEPI was recalled in March 2022 due to quality control issues, which affected its commercial availability and sales.

Who is promoting SYMJEPI?

US WorldMeds is promoting SYMJEPI through its field sales force, following a partnership agreement with Adamis Pharmaceuticals.

What are the financial implications of the SYMJEPI recall?

The recall resulted in a $2.0 million reserve reduction in revenue for 2021 and impacted the company's overall financial performance.

What are the future prospects for SYMJEPI?

The product is expected to be relaunched before the end of the first quarter of 2023, and there are significant growth opportunities in the expanding epinephrine autoinjector market.

Sources

1. Mordor Intelligence: Epinephrine Autoinjector Market Size & Share Analysis
2. BioSpace: Adamis Pharmaceuticals Reports Third Quarter 2022 Financial Results and Provides Corporate Update
3. Annual Reports: ADAMIS PHARMACEUTICALS CORPORATION - Annual Reports
4. BioSpace: Adamis Pharmaceuticals Provides Update on SYMJEPI Products
5. GlobeNewswire: Adamis Pharmaceuticals Reports Full Year 2021 Financial Results and Provides Corporate Update