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RAPIVAB Drug 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 four patents protecting this drug.

This drug has sixty-three 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.

US ANDA Litigation and 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 September 20, 2020. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for RAPIVAB

International Patents:	63
US Patents:	4
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	57
Clinical Trials:	2
Patent Applications:	56
Drug Prices:	Drug price information for RAPIVAB
DailyMed Link:	RAPIVAB at DailyMed

See drug prices for RAPIVAB

Generic Entry Opportunity Date for RAPIVAB

Constraining patent/regulatory exclusivity:

NEW PATIENT POPULATION

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
BioCryst Pharmaceuticals	Phase 3
Department of Health and Human Services	Phase 4
Johns Hopkins University	Phase 4

See all RAPIVAB clinical trials

Synonyms for RAPIVAB

(-)-(1S,2S,3R,4R)-3-[(1S)-1-(Acetylamino)-2-ethylbutyl]-4-{[amino(imino)methyl]amino}-2-hydroxycyclopentanecarboxylic Acid

(+/-)-Peramivir

(1s,2s,3r,4r)-3-((1s)-1-acetylamino-2-ethylbutyl))-4-((aminoiminomethyl)amino)-2-hydroxycyclopentane

(1S,2S,3R,4R)-3-((S)-1-acetamido-2-ethylbutyl)-4-guanidino-2-hydroxycyclopentane-1-carboxylic acid

(1S,2S,3R,4R)-3-((S)-1-Acetamido-2-ethylbutyl)-4-guanidino-2-hydroxycyclopentanecarboxylic acid

(1S,2S,3R,4R)-3-(1-acetaMido-2-ethylbutyl)-4-guanidino-2-hydroxycyclopentanecarboxylic acid (Peramivir)

(1S,2S,3R,4R)-3-[(1S)-1-(acetylamino)-2-ethylbutyl]-4-carbamimidamido-2-hydroxycyclopentanecarboxylic acid

(1S,2S,3R,4R)-3-[(1S)-1-acetamido-2-ethyl-butyl]-4-guanidino-2-hydroxy-cyclopentanecarboxylic acid

(1S,2S,3R,4R)-3-[(1S)-1-acetamido-2-ethylbutyl]-4-carbamimidamido-2-hydroxycyclopentane-1-carboxylic acid

(1S,2S,3R,4R)-3-[(1S)-1-acetamido-2-ethylbutyl]-4-carbamimidamido-2-hydroxycyclopentane-1-carboxylic acid--water (1/3)

(1S,2S,3R,4R)-4-carbamimidamido-3-[(1S)-1-acetamido-2-ethylbutyl]-2-hydroxycyclopentane-1-carboxylic acid

(1S,2S,3S,4R)-3-((S)-1-acetamido-2-ethylbutyl)-4-((diaminomethylene)amino)-2-hydroxycyclopentane-1-carboxylic acid

(1S,2S,3S,4R)-3-[(1S)-1-acetamido-2-ethylbutyl]-4-(diaminomethylideneamino)-2-hydroxycyclopentane-1-carboxylic acid

229614-55-5

229614-55-5,330600-85-6,1041434-82-5(3H2O)

229614-56-6

3-(1-ACETYLAMINO-2-ETHYL-BUTYL)-4-GUANIDINO-2-HYDROXY-CYCLOPENTANECARBOXYLIC ACID

3-(1'-acetylamino-2'-ethyl)butyl-4-((aminoimino)methyl)amino-2-hydroxycyclopentane-1-carboxylic acid

3(R)-[1(S)-Acetamido-2-ethylbutyl]-4(R)-guanidino-2(S)-hydroxycyclopentane-1(S)-carboxylic acid

330600-85-6

600P856

9ZS94HQO3B

AB01566838_01

AB2000310

ABP000969

AC-22715

AC1L4BWX

AJ-47581

AK-48380

AKOS016007760

API0004841

AX8147150

BCPP000117

BCX 1812

BCX-1812

BCX1812

BCZ

BDBM50181441

BDBM5024

CHEBI:85196

CHEBI:85202

CHEMBL139367

CP0131

CS-0638

Cyclopentanecarboxylic acid, 3-((1R)-1-(acetylamino)-2-ethylbutyl)-4-((aminoiminomethyl)amino)-2-hydroxy-, (1R,2R,3S,4S)-rel-

Cyclopentanecarboxylic acid, 3-((1S)-1-(acetylamino)-2-ethylbutyl)-4-((aminoiminomethyl)amino)-2-hydroxy-, (1S,2S,3R,4R)-

Cyclopentanecarboxylic acid, 3-[(1S)-1-(acetylamino)-2-ethylbutyl]-4-[(aminoiminomethyl)amino]-2-hydroxy-, (1S,2S,3R,4R)-

DB06614

HY-17015A

PeramiFlu

Peramivir

Peramivir [USAN:INN]

Peramivir hydrate

Peramivir, (+/-)-

Rapiacta

RL02720

RL03191

RWJ 270201

RWJ-270201

RWJ270201

S-021812

SCHEMBL12795462

SCHEMBL744373

ST2402123

UNII-9ZS94HQO3B

ZINC3981610

US Patents and Regulatory Information for RAPIVAB

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
Biocryst	RAPIVAB	peramivir	SOLUTION;INTRAVENOUS	206426-001	Dec 19, 2014		RX	Yes	Yes				Y

Expired US Patents for RAPIVAB

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

International Patents for RAPIVAB

Country	Patent Number	Estimated Expiration
Canada	2315262
Japan	5118502
Hong Kong	1212250