PERAMIVIR - Generic Drug Details

What are the generic sources for peramivir and what is the scope of patent protection?

Peramivir is the generic ingredient in one branded drug marketed by Biocryst and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Peramivir has forty-two patent family members in fourteen countries.

There is one drug master file entry for peramivir. One supplier is listed for this compound.

Summary for PERAMIVIR

International Patents:	42
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	146
Clinical Trials:	16
Patent Applications:	2,587
What excipients (inactive ingredients) are in PERAMIVIR?	PERAMIVIR excipients list
DailyMed Link:	PERAMIVIR at DailyMed

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

Dosage:

SOLUTION;INTRAVENOUS

^*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 PERAMIVIR

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

Sponsor	Phase
University of Oxford	Phase 2
Hoffmann-La Roche	Phase 3
Department of Health and Human Services	Phase 4

See all PERAMIVIR clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for PERAMIVIR

J05AH	Neuraminidase inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for PERAMIVIR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Biocryst	RAPIVAB	peramivir	SOLUTION;INTRAVENOUS	206426-001	Dec 19, 2014		RX	Yes	Yes
Biocryst	RAPIVAB	peramivir	SOLUTION;INTRAVENOUS	206426-001	Dec 19, 2014		RX	Yes	Yes

Expired US Patents for PERAMIVIR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Biocryst	RAPIVAB	peramivir	SOLUTION;INTRAVENOUS	206426-001	Dec 19, 2014
Biocryst	RAPIVAB	peramivir	SOLUTION;INTRAVENOUS	206426-001	Dec 19, 2014

EU/EMA Drug Approvals for PERAMIVIR

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Biocryst	Alpivab	peramivir	EMEA/H/C/004299 Alpivab is indicated for the treatment of uncomplicated influenza in adults and children from the age of 2 years.	Withdrawn	no	no	no	2018-04-13

International Patents for PERAMIVIR

Country	Patent Number	Title	Estimated Expiration
Eurasian Patent Organization	200870263	ВНУТРИВЕННЫЙ СПОСОБ ЛЕЧЕНИЯ ВИРУСНОЙ ИНФЕКЦИИ
Eurasian Patent Organization	025483	ВНУТРИВЕННЫЙ СПОСОБ ЛЕЧЕНИЯ СЕЗОННОГО ГРИППА (INTRAVENOUS METHOD FOR TREATING A SEASONAL INFLUENZA)
Japan	2013256527	INTRAVENOUS ANTIVIRAL TREATMENT
China	104784166	Antiviral compound, dosage form including same, and uses thereof
Malaysia	166063	INTRAVENOUS ANTIVIRAL TREATMENTS
South Korea	102194015
Hong Kong	1212250	抗病毒化合物、包含該化合物的劑型及其用途 (ANTIVIRAL COMPOUNDS, UNIT DOSAGE FORM COMPRISING SAID COMPOUNDS AND USE THEREOF)

PERAMIVIR Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Peramivir

Overview of Peramivir

Peramivir, marketed under the brand name RAPIVAB, is an intravenous antiviral medication approved for the treatment of acute uncomplicated influenza in patients six months and older who have been symptomatic for no more than two days. It is administered via an intravenous infusion and has been a crucial component in the U.S. government’s influenza preparedness efforts since the 2009 H1N1 pandemic[2].

Market Size and Growth

The global influenza treatment market, which includes Peramivir, is projected to experience significant growth. As of 2023, the global influenza treatment market was valued at USD 1.24 billion and is expected to reach USD 1.79 billion by 2032, growing at a CAGR of 4.2%[1].

Regional Market Dynamics

North America

North America is the largest market shareholder for influenza treatments, including Peramivir. This region is expected to exhibit a CAGR of 3.9% over the forecast period. The demand for Peramivir in North America is driven by factors such as the increase in prevalence of influenza, government guidelines on the use of antiviral medications, and easy access to these medications. The U.S. Food and Drug Administration (FDA) recommendations and the strategic stockpiling of Peramivir by the U.S. government further boost its demand[1].

Europe

Europe is predicted to be the fastest-growing market for influenza treatments, with a CAGR of 5.6%. The rise in influenza infections in Europe and the presence of major competitors making antiviral medications widely available are key drivers of this growth[1].

Asia-Pacific and LAMEA

The Asia-Pacific region, particularly countries like India, is also experiencing significant growth due to a large patient base and increasing awareness about early diagnosis and treatment of influenza. The LAMEA region, with its growing healthcare expenditures and high prevalence of influenza infections, presents lucrative opportunities for the market[1][4].

Product Segment Dynamics

Peramivir is one of the key products in the influenza treatment market, alongside Oseltamivir Phosphate, Zanamivir, and Baloxavir Marboxil. The Oseltamivir Phosphate segment currently dominates the market, but Peramivir remains a vital component due to its efficacy and the government's strategic stockpiling efforts. The segment including Peramivir and other antiviral medications is expected to grow significantly, driven by the increasing prevalence of influenza and advancements in R&D[1][4].

Government Contracts and Stockpiling

The U.S. Department of Health and Human Services (HHS) has awarded BioCryst Pharmaceuticals, the manufacturer of RAPIVAB (Peramivir), a contract worth up to $69 million for the procurement of up to 95,625 doses over a five-year period. This contract is part of the Center for the Strategic National Stockpile (SNS) to ensure readiness for public health emergencies. Such government contracts significantly impact the financial trajectory of Peramivir by ensuring a steady demand and revenue stream[2].

Financial Performance

BioCryst Pharmaceuticals, the company behind RAPIVAB, has seen notable financial performance related to this drug. For instance, in 2018, the company received a $34.7 million contract for the procurement of up to 50,000 doses of RAPIVAB, which was completed by 2022. The new contract of up to $69 million further solidifies the financial outlook for Peramivir. BioCryst's total revenues have also shown growth, with a 14.4% increase in the third quarter of 2023 compared to the same period in 2022[2][5].

Mechanism of Action and Clinical Significance

Peramivir works by inhibiting the neuraminidase enzyme on the influenza virus, preventing the virus from spreading in the respiratory tract. This mechanism of action makes it an effective treatment for acute uncomplicated influenza. Clinical trials have demonstrated its efficacy, particularly against influenza A and B viruses[2].

Challenges and Opportunities

While the market for Peramivir is growing, there are challenges such as the adoption of influenza vaccines, which can reduce the demand for antiviral treatments. However, the high growth potential in developing economies and the ongoing R&D investments in antiviral drugs present significant opportunities for market expansion[4].

Key Takeaways

• Market Growth: The global influenza treatment market, including Peramivir, is expected to grow at a CAGR of 4.2% from 2023 to 2032.
• Regional Dynamics: North America is the largest market, while Europe is the fastest-growing region.
• Government Contracts: Significant government contracts, such as the $69 million contract with HHS, drive the demand and financial performance of Peramivir.
• Mechanism of Action: Peramivir inhibits the neuraminidase enzyme, making it an effective treatment for influenza.
• Challenges and Opportunities: Despite challenges from vaccine adoption, opportunities in developing economies and R&D investments are promising.

FAQs

1. What is Peramivir used for? Peramivir is used for the treatment of acute uncomplicated influenza in patients six months and older who have been symptomatic for no more than two days.

2. How is Peramivir administered? Peramivir is administered via an intravenous infusion for a minimum of 15 minutes at recommended doses.

3. What is the significance of government contracts for Peramivir? Government contracts, such as the one with HHS, ensure a steady demand and revenue stream for Peramivir, making it a crucial component of public health emergency preparedness.

4. Which region is the largest market for Peramivir? North America is the largest market shareholder for influenza treatments, including Peramivir.

5. What are the challenges facing the market for Peramivir? The adoption of influenza vaccines is a significant challenge that can reduce the demand for antiviral treatments like Peramivir.

Sources

1. Straits Research: Global Influenza Treatment Market Size & Share analysis till 2032
2. BioCryst Pharmaceuticals: U.S. Government Awards BioCryst $69 Million RAPIVAB® (peramivir injection) Contract
3. Market Research Intellect: Global Influenza Antiviral Drugs Market Size, Trends and Projections
4. Allied Market Research: Influenza Treatment Market Size, Share | Industry Growth, 2026
5. FirstWord Pharma: BioCryst Reports Third Quarter 2023 Financial Results and Provides Business Update