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Last Updated: February 27, 2020

DrugPatentWatch Database Preview

ESBRIET Drug Profile


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When do Esbriet patents expire, and what generic alternatives are available?

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-four patent family members in forty-four 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 eleven 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

See drug prices for ESBRIET

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
Royal Brompton & Harefield NHS Foundation TrustPhase 4
H. Lee Moffitt Cancer Center and Research InstitutePhase 1

See all ESBRIET clinical trials

Recent Litigation for ESBRIET

Identify potential future generic entrants

District Court Litigation
Case NameDate
Genentech, Inc. v. Teva Pharmaceuticals USA, Inc.2019-01-24
Genentech, Inc. v. Shilpa Medicare Limited2019-01-23
Genentech, Inc. v. Apotex Inc.2019-01-22

See all ESBRIET litigation

Pharmacology for ESBRIET
Drug ClassPyridone
Synonyms for ESBRIET
1-phenyl-5-methyl-2-pyridinone
179P138
2(1H)-Pyridinone, 5-methyl-1-phenyl-
2(1H)-Pyridone, 5-methyl-1-phenyl-
4CH-013041
5-21-07-00197 (Beilstein Handbook Reference)
5-Methyl-1-phenyl-1H-pyridin-2-one
5-methyl-1-phenyl-2-(1H)-pyridinone;
5-Methyl-1-phenyl-2-(1H)-pyridone
5-methyl-1-phenyl-2-pyridinone
5-Methyl-1-phenyl-2-pyridone
5-methyl-1-phenyl-2(1H)-pyridinone
5-Methyl-1-phenyl-2(1H)-pyridone
5-methyl-1-phenyl-pyridin-2-one
5-methyl-1-phenylpyridin-2-one
5-methyl-1-phenylpyridin-2(1H)-one
5-METHYL-N-PHENYL-2-1H-PYRIDONE
53179-13-8
A829431
AB0006721
AB07515
AC-6797
AC1L2454
ACMC-209t1g
AJ-08117
AK-72929
AKOS006273697
AM84939
AMR 69
AMR-69
AMR69
AN-5207
ANW-41906
AOB31717
API0003873
AX8028958
B2288
BC678265
BCP04473
BDBM50005201
Bio1_000397
Bio1_000886
Bio1_001375
BN0421
BR-72929
BRD-K96862998-001-03-1
BRD-K96862998-001-09-8
BRN 1526549
C-07370
CAS-53179-13-8
CC-33825
CCG-204989
CHEBI:32016
CHEMBL1256391
CP0088
CS-2905
CTK8B3176
D01583
D7NLD2JX7U
DB04951
Deskar
DSSTox_CID_25183
DSSTox_GSID_45183
DSSTox_RID_80731
DTXSID4045183
EBD52457
EN000704
Esbriet (TN)
EU-0100907
F-647
FCH842465
FT-0082541
FT-0602686
GP4948
GTPL7532
H960
HMS2234G24
HMS3262F16
HMS3267I06
HMS3372A08
HMS3651P08
HSDB 8340
HY-B0673
I01-1466
ISWRGOKTTBVCFA-UHFFFAOYSA-N
J-523979
J90039
KB-246459
KS-5041
Lopac-P-2116
Lopac0_000907
LP00907
LS-133834
M-2515
MFCD00866047
MFCD00866047 (97%)
MLS000860042
MolPort-003-666-737
NCGC00015806-01
NCGC00015806-02
NCGC00015806-03
NCGC00015806-04
NCGC00015806-05
NCGC00015806-06
NCGC00024992-01
NCGC00024992-02
NCGC00024992-03
NCGC00261592-01
NSC-748456
NSC748456
P 2116
P1871
Pirespa
Pirfenidona
Pirfenidona [INN-Spanish]
PIRFENIDONE
Pirfenidone (Deskar)
Pirfenidone (JAN/USAN/INN)
Pirfenidone [USAN:INN]
Pirfenidone D5
Pirfenidone, >=97% (HPLC)
Pirfenidone, European Pharmacopoeia (EP) Reference Standard
Pirfenidone(AMR69)
Pirfenidonum
Pirfenidonum [INN-Latin]
Prfendone
RP24541
RTR-018809
s2907
SC-17366
SCHEMBL4708
SMR000326900
SR-01000076061
SR-01000076061-1
SR-01000076061-3
ST2418816
SW220156-1
SY034783
Tocris-1093
Tox21 110225
Tox21_110225
Tox21_110225_1
Tox21_500907
UNII-D7NLD2JX7U
ZB000448
ZINC1958
Paragraph IV (Patent) Challenges for ESBRIET
Tradename Dosage Ingredient NDA Submissiondate
ESBRIET TABLET;ORAL pirfenidone 208780 2018-10-15
ESBRIET CAPSULE;ORAL pirfenidone 022535 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   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:

Mallinckrodt
Medtronic
Moodys
McKesson
Dow
Merck

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 verifification 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.