RIVIVE Drug Patent Profile

Which patents cover Rivive, and what generic alternatives are available?

Rivive is a drug marketed by Harm Reduction Therp and is included in one NDA. There are two patents protecting this drug.

This drug has fifty-one patent family members in thirty-six countries.

The generic ingredient in RIVIVE is naloxone hydrochloride. There are twelve drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the naloxone hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Rivive

A generic version of RIVIVE was approved as naloxone hydrochloride by HOSPIRA on September 24^th, 1986.

Summary for RIVIVE

International Patents:	51
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
What excipients (inactive ingredients) are in RIVIVE?	RIVIVE excipients list
DailyMed Link:	RIVIVE at DailyMed

Pharmacology for RIVIVE

Drug Class	Opioid Antagonist
Mechanism of Action	Opioid Antagonists

US Patents and Regulatory Information for RIVIVE

RIVIVE is protected by two US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Harm Reduction Therp	RIVIVE	naloxone hydrochloride	SPRAY, METERED;NASAL	217722-001	Jul 28, 2023		OTC	Yes	Yes	11,020,343
Harm Reduction Therp	RIVIVE	naloxone hydrochloride	SPRAY, METERED;NASAL	217722-001	Jul 28, 2023		OTC	Yes	Yes	11,806,428		Y

International Patents for RIVIVE

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

Country	Patent Number	Title	Estimated Expiration
Israel	229409	צורות מינון רוקחיות תוך אפיות המכילות נאלוקסון (Intranasal pharmaceutical dosage forms comprising naloxone)
Russian Federation	2657441	ИНТРАНАЗАЛЬНЫЕ ФАРМАЦЕВТИЧЕСКИЕ ДОЗИРОВАННЫЕ ФОРМЫ, СОДЕРЖАЩИЕ НАЛОКСОН (INTRANASAL PHARMACEUTICAL DOSAGE FORMS COMPRISING NALOXONE)
South Korea	20140007482	INTRANASAL PHARMACEUTICAL DOSAGE FORMS COMPRISING NALOXONE
Russian Federation	2587051	ИНТРАНАЗАЛЬНЫЕ ФАРМАЦЕВТИЧЕСКИЕ ДОЗИРОВАННЫЕ ФОРМЫ, СОДЕРЖАЩИЕ НАЛОКСОН (INTRANASAL PHARMACEUTICAL DOSAGE FORMS COMPRISING NALOXONE)
Russian Federation	2013155479	ИНТРАНАЗАЛЬНЫЕ ФАРМАЦЕВТИЧЕСКИЕ ДОЗИРОВАННЫЕ ФОРМЫ, СОДЕРЖАЩИЕ НАЛОКСОН

Supplementary Protection Certificates for RIVIVE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1685839	92292	Luxembourg		PRODUCT NAME: COMBINAISON D OXYCODONE EN TANT QUE COMPOSANT A ET DE NALOXONE EN TANT QUE COMPOSANT B SOUS TOUTES LES FORMES PROTEGES PAR LE BREVET DE BASE

RIVIVE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Reviva Pharmaceuticals

Introduction

Reviva Pharmaceuticals Holdings, Inc. is a late-stage pharmaceutical company focused on developing therapies to address unmet medical needs in central nervous system (CNS), inflammatory, and cardiometabolic diseases. This article delves into the market dynamics and financial trajectory of Reviva Pharmaceuticals, highlighting key aspects of their operations, financial performance, and market trends.

Market Context

Pharmaceutical Market Trends

The pharmaceutical market, particularly in the U.S., is characterized by several key trends. Biologics continue to grow at a higher pace than non-biologics, with specialty drugs accounting for more than half of the total market. This trend is significant as it indicates a shift towards more targeted and often more expensive therapies[4].

Competitive Landscape

The retail pharmacy sector is undergoing significant changes, with almost 700 pharmacies closing in the U.S. over the last two years. This includes closures at major chains like CVS, Walgreens, and Rite Aid. Additionally, the rise of online pharmacy services, such as Amazon Pharmacy, is altering the way prescriptions are filled and priced[4].

Reviva Pharmaceuticals' Focus Areas

Therapeutic Areas

Reviva Pharmaceuticals is primarily focused on developing therapies for CNS, inflammatory, and cardiometabolic diseases. These areas represent significant unmet medical needs and are critical for the company's growth strategy. For instance, their drug candidate Brilaroxazine is being developed for the treatment of schizophrenia and bipolar disorder, which are part of the CNS therapeutic area[5].

Financial Performance

Full Year 2023 Financial Results

For the year ended December 31, 2023, Reviva Pharmaceuticals reported a net loss of approximately $39.3 million, or $1.65 per share. This compares to a net loss of approximately $28.3 million, or $1.45 per share, for the year ended December 31, 2022. The increase in net loss is largely due to higher research and development expenses, which rose to $31.4 million in 2023 from $22.9 million in 2022[2].

Cash and Cash Equivalents

As of December 31, 2023, the company's cash and cash equivalents totaled approximately $23.4 million, compared to $18.5 million as of December 31, 2022. However, by March 31, 2024, this figure had decreased to approximately $12.0 million, reflecting ongoing operational expenses[2][5].

Quarterly Financial Performance

For the first quarter of 2024, Reviva Pharmaceuticals reported a net loss of approximately $7.4 million, or $0.25 per share, compared to a net loss of approximately $6.9 million, or $0.31 per share, for the same period in 2023. This indicates a continued investment in research and development activities[5].

Research and Development Expenses

Breakdown of Expenses

Research and development expenses are a significant component of Reviva Pharmaceuticals' financials. In 2023, these expenses totaled $31.4 million, up from $22.9 million in 2022. For the first quarter of 2024, R&D expenses were $5.8 million, slightly higher than the $5.5 million in the same period of 2023[2][5].

Market Opportunities and Challenges

Commercial Potential

The commercial potential of new drugs is a critical factor in the pharmaceutical industry. Investors and big biopharma companies assess the addressable patient populations, levels of unmet need, drug-value propositions, expected uptake, and pricing potential. These assessments drive the investment decisions and strategic considerations for bringing a product to market[3].

Regulatory Incentives

Reviva Pharmaceuticals, like other companies in the sector, leverages regulatory incentives such as Orphan Drug, Fast Track, Breakthrough Therapy, and Rare Pediatric Disease designations to enhance shareholder value. These designations can provide significant advantages in terms of expedited review processes and market exclusivity[2].

Competitive Advantage

Unique Drug Candidates

Reviva Pharmaceuticals has a unique portfolio of drug candidates, including Brilaroxazine, which is in development for CNS disorders. The company's focus on addressing unmet medical needs in specific therapeutic areas helps it stand out in a competitive market[5].

Global Willingness to Pay

Impact on Drug Development

The global willingness to pay for new pharmaceutical drugs significantly influences the supply and distribution of novel drugs. In key global markets, affordability issues can affect the willingness to pay, particularly for more personalized and segmented treatments. This can impact the development of drugs in certain therapeutic areas, with those having the highest expected willingness to pay being more likely to be developed[3].

Conclusion

Reviva Pharmaceuticals operates in a dynamic pharmaceutical market characterized by growing demand for biologics and specialty drugs, and significant changes in the retail pharmacy sector. The company's financial trajectory reflects its ongoing investment in research and development, particularly in CNS, inflammatory, and cardiometabolic diseases.

Key Takeaways

• Market Trends: Biologics and specialty drugs are driving growth in the pharmaceutical market.
• Financial Performance: Reviva Pharmaceuticals reported a net loss of $39.3 million in 2023, with cash and cash equivalents decreasing to $12.0 million by March 2024.
• Research and Development: R&D expenses are a significant component of the company's financials, reflecting its focus on developing new therapies.
• Regulatory Incentives: Leveraging regulatory designations to expedite review processes and gain market exclusivity.
• Commercial Potential: Assessing commercial potential is crucial for investment decisions and strategic planning.

FAQs

Q: What are the primary therapeutic areas Reviva Pharmaceuticals is focused on?

A: Reviva Pharmaceuticals is primarily focused on developing therapies for central nervous system (CNS), inflammatory, and cardiometabolic diseases.

Q: How has the net loss of Reviva Pharmaceuticals changed from 2022 to 2023?

A: The net loss increased from approximately $28.3 million in 2022 to approximately $39.3 million in 2023.

Q: What is the current cash position of Reviva Pharmaceuticals as of March 31, 2024?

A: As of March 31, 2024, the company's cash and cash equivalents totaled approximately $12.0 million.

Q: What is Brilaroxazine, and what is it being developed for?

A: Brilaroxazine is a drug candidate being developed by Reviva Pharmaceuticals for the treatment of schizophrenia and bipolar disorder.

Q: How do global willingness to pay and affordability issues impact drug development?

A: The global willingness to pay significantly influences the supply and distribution of novel drugs, with affordability issues affecting the development of drugs in certain therapeutic areas.

Sources

1. Revive Therapeutics Provides Update on Cannabinoid Pharmaceuticals Program - BioSpace
2. Reviva Reports Full Year 2023 Financial Results and Recent Business Highlights - Reviva Pharmaceuticals
3. The Financial Ecosystem of Pharmaceutical R&D - RAND
4. Insights Into the 2023 U.S. Pharmaceutical Market - IQVIA
5. Reviva Reports First Quarter 2024 Financial Results and Recent Business Highlights - Reviva Pharmaceuticals