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Generated: March 23, 2019

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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 patents protecting this drug and two Paragraph IV challenges.

This drug has two hundred and thirty-seven patent family members in forty-two countries.

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

Drug patent expirations by year 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.

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

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 ➤ Sign Up ➤ Sign Up ➤ Sign Up
Genentech Inc ESBRIET pirfenidone TABLET;ORAL 208780-003 Jan 11, 2017 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Genentech Inc ESBRIET pirfenidone TABLET;ORAL 208780-002 Jan 11, 2017 DISCN Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
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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Paragraph IV (Patent) Challenges for ESBRIET
Drugname Dosage Strength RLD Date
➤ Subscribe Tablets 267 mg, 534 mg and 801 mg ➤ Subscribe ➤ Sign Up
➤ Subscribe Capsules 267 mg ➤ Subscribe ➤ Sign Up

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