RAPIVAB Drug Patent Profile

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

Rapivab is a drug marketed by Biocryst and is included in one NDA. There are three patents protecting this drug.

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

The generic ingredient in RAPIVAB is peramivir. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the peramivir profile page.

DrugPatentWatch^® Generic Entry Outlook for Rapivab

Rapivab was eligible for patent challenges on December 19, 2018.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 16, 2023. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for RAPIVAB

International Patents:	70
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	90
Clinical Trials:	3
Patent Applications:	1,133
Drug Prices:	Drug price information for RAPIVAB
What excipients (inactive ingredients) are in RAPIVAB?	RAPIVAB excipients list
DailyMed Link:	RAPIVAB at DailyMed

Drug patent expirations by year for RAPIVAB

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

Generic Entry Date for RAPIVAB^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: ⤷ Try a Trial NDA: 206426 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 RAPIVAB

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

Sponsor	Phase
University of Oxford	Phase 2
BioCryst Pharmaceuticals	Phase 3
Johns Hopkins University	Phase 4

See all RAPIVAB clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for RAPIVAB

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

US Patents and Regulatory Information for RAPIVAB

RAPIVAB is protected by six US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of RAPIVAB is ⤷ Try a Trial.

This potential generic entry date is based on patent ⤷ Try a Trial.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting RAPIVAB

Antiviral treatments
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF ACUTE UNCOMPLICATED INFLUENZA IN PATIENTS 2 YEARS AND OLDER

Antiviral treatments
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF ACUTE UNCOMPLICATED INFLUENZA IN PATIENTS 6 MONTHS AND OLDER

Substituted cyclopentane and cyclopentene compounds useful as neuraminidase inhibitors
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

Antiviral treatments
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF ACUTE UNCOMPLICATED INFLUENZA IN PATIENTS 2 YEARS AND OLDER

Antiviral treatments
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF ACUTE UNCOMPLICATED INFLUENZA IN ADULTS

Antiviral treatments
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF ACUTE UNCOMPLICATED INFLUENZA IN PATIENTS 6 MONTHS AND OLDER

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Glossary

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

Expired US Patents for RAPIVAB

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

EU/EMA Drug Approvals for RAPIVAB

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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
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for RAPIVAB

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

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Country	Patent Number	Title	Estimated Expiration
Mexico	2020002008	TRATAMIENTOS ANTIVIRALES INTRAVENOSOS. (INTRAVENOUS ANTIVIRAL TREATMENTS.)	⤷ Try a Trial
Poland	341431		⤷ Try a Trial
Japan	5709688		⤷ Try a Trial
World Intellectual Property Organization (WIPO)	2007117241		⤷ Try a Trial
Brazil	9813480		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration