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Last Updated: July 6, 2020

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ESBRIET Drug Profile


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Which patents cover Esbriet, and when can generic versions of Esbriet launch?

Esbriet is a drug marketed by Genentech Inc and is included in two NDAs. There are twenty-one patents protecting this drug and two Paragraph IV challenges.

This drug has two hundred and fifty-nine patent family members in forty-five countries.

The generic ingredient in ESBRIET is pirfenidone. There are twenty-three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the pirfenidone profile page.

US ANDA Litigation and Generic Entry Outlook for Esbriet

Esbriet was eligible for patent challenges on October 16, 2018.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be September 22, 2026. This may change due to patent challenges or generic licensing.

There have been thirteen patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There is one tentative approval for the generic drug (pirfenidone), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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Drug patent expirations by year for ESBRIET
Drug Prices for ESBRIET

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Generic Entry Opportunity Date for ESBRIET
Generic Entry Dates for ESBRIET*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
CAPSULE;ORAL
Generic Entry Dates for ESBRIET*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL

*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 ESBRIET

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

SponsorPhase
Jesse RomanPhase 2
University of California, Los AngelesPhase 2
Royal Brompton & Harefield NHS Foundation TrustPhase 4

See all ESBRIET clinical trials

Pharmacology for ESBRIET
Drug ClassPyridone
Paragraph IV (Patent) Challenges for ESBRIET
Tradename Dosage Ingredient NDA Submissiondate
ESBRIET CAPSULE;ORAL pirfenidone 022535 2018-10-15
ESBRIET TABLET;ORAL pirfenidone 208780 2018-10-15

US Patents and Regulatory Information for ESBRIET

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Genentech Inc ESBRIET pirfenidone TABLET;ORAL 208780-002 Jan 11, 2017 DISCN Yes No   Start Trial   Start Trial   Start Trial
Genentech Inc ESBRIET pirfenidone TABLET;ORAL 208780-003 Jan 11, 2017 RX Yes Yes   Start Trial   Start Trial   Start Trial
Genentech Inc ESBRIET pirfenidone TABLET;ORAL 208780-002 Jan 11, 2017 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Genentech Inc ESBRIET pirfenidone TABLET;ORAL 208780-003 Jan 11, 2017 RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

Colorcon
Baxter
Mallinckrodt
Boehringer Ingelheim
Merck
Medtronic

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.