Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving leading biopharmaceutical companies globally:

Baxter
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Medtronic
Boehringer Ingelheim
McKinsey

Last Updated: October 23, 2019

DrugPatentWatch Database Preview

ENTEREG Drug Profile

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

Entereg is a drug marketed by Cubist Pharms and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has twenty patent family members in fourteen countries.

The generic ingredient in ENTEREG is alvimopan. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the alvimopan profile page.

Drug patent expirations by year for ENTEREG
Drug Prices for ENTEREG

See drug prices for ENTEREG

Generic Entry Opportunity Date for ENTEREG
Generic Entry Date for ENTEREG*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
CAPSULE;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 ENTEREG

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

SponsorPhase
University of California, San DiegoPhase 2
University of Puerto RicoPhase 4
Brigham and Women's HospitalPhase 3

See all ENTEREG clinical trials

Recent Litigation for ENTEREG

Identify potential future generic entrants

District Court Litigation
Case NameDate
MERCK SHARP & DOHME CORP. v. TEVA PHARMACEUTICALS USA, INC.2017-09-08
CELGENE CORPORATION v. LOTUS PHARMACEUTICAL CO., LTD.2017-09-06

See all ENTEREG litigation

Pharmacology for ENTEREG
Drug ClassOpioid Antagonist
Mechanism of ActionOpioid Antagonists
Synonyms for ENTEREG
(((2S)-2-(((3R,4R)-4-(3-hydroxyphenyl)-3,4-dimethylpiperidin-1-yl)methyl)-3-phenylpropanoyl)amino)acetic acid dihydrate
((S)-2-benzyl-3-((3R,4R)-4-(3-hydroxyphenyl)-3,4-dimethylpiperidin-1-yl)propanoyl)glycine dihydrate
(2S, 3R, 4R)[[2-[[4-(3-hydroxyphenyl)-3,4-dimethyl-1-piperidinyl ]methyl]-1-oxo-3-phenylpropyl]-amino]acetic acid dihydrate
[[(S)-2-Benzyl-3-[(3R,4R)-4-(3-hydroxyphenyl)-3,4-dimethylpiperidin-1-yl]propionyl]amino]acetic acid
053A893
098A381
145590-44-9
156053-89-3
156053-89-3 (anhydrous)
170098-38-1
170098-38-1 (dihydrate)
2-((S)-2-benzyl-3-((3R,4R)-4-(3-hydroxyphenyl)-3,4-dimethylpiperidin-1-yl)propanamido)acetic acid
2-[(2S)-2-benzyl-3-[(3R,4R)-4-(3-hydroxyphenyl)-3,4-dimethylpiperidin-1-yl]propanamido]acetic acid
2-[(2S)-2-benzyl-3-[(3R,4R)-4-(3-hydroxyphenyl)-3,4-dimethylpiperidin-1-yl]propanamido]acetic acid dihydrate
2-[[(2S)-2-[[(3R,4R)-4-(3-hydroxyphenyl)-3,4-dimethylpiperidin-1-yl]methyl]-3-phenylpropanoyl]amino]acetic acid
2-[[(2S)-2-benzyl-3-[(3R,4R)-4-(3-hydroxyphenyl)-3,4-dimethyl-1-piperi dyl]propanoyl]amino]acetic acid dihydrate
2-[[(2S)-2-benzyl-3-[(3R,4R)-4-(3-hydroxyphenyl)-3,4-dimethyl-1-piperidyl]propanoyl]amino]acetic acid dihydrate
2-[[(2S)-2-benzyl-3-[(3R,4R)-4-(3-hydroxyphenyl)-3,4-dimethylpiperidin-1-yl]propanoyl]amino]acetic acid
2-[[(2S)-2-benzyl-3-[(3R,4R)-4-(3-hydroxyphenyl)-3,4-dimethylpiperidin-1-yl]propanoyl]amino]acetic acid dihydrate
2-[[(2S)-2-benzyl-3-[(3R,4R)-4-(3-hydroxyphenyl)-3,4-dimethylpiperidin-1-yl]propanoyl]amino]acetic acid,dihydrate
2-[[(2S)-2-benzyl-3-[(3R,4R)-4-(3-hydroxyphenyl)-3,4-dimethylpiperidin-1-yl]propanoyl]amino]acetic acid;dihydrate
3436AH
4CH-023254
677C126AET
A11881
AC-8813
AC1NUQN3
AC1NUQN6
ACN-047960
Adl 8-2698
ADL-8-2698
AJ-45653
AK119795
AK161801
AKOS015896476
AKOS015899533
Alvimopan
Alvimopan (dihydrate)
Alvimopan (USAN)
Alvimopan [INN]
Alvimopan [USAN:INN:BAN]
Alvimopan [USAN]
Alvimopan anhydrous
Alvimopan dihydrate
Alvimopan hydrate
Alvimopan, >=98% (HPLC)
Alvimopan(dihydrate)
AM84590
AN-7616
anhydrous alvimopan
API0025949
AS-35088
AX8245211
AX8256955
BC658544
BCP10120
BDBM50088381
C25H32N2O4
C25H32N2O4.2H2O
CHEBI:135686
CHEMBL270190
CS-0536
CS-1540
CTK4D3485
CTK8F0805
D02878
DB06274
DTXSID40168794
DTXSID60166035
Entereg (TN)
Entrareg
FT-0652843
FT-0687493
Glycine, N-((2S)-2-(((3R,4R)-4-(3-hydroxyphenyl)-3,4-dimethyl-1-piperidinyl)methyl)-1-oxo-3-phenylpropyl)-
Glycine, N-((2S)-2-(((3R,4R)-4-(3-hydroxyphenyl)-3,4-dimethyl-1-piperidinyl)methyl)-1-oxo-3-phenylpropyl)-, dihydrate
Glycine, N-(2-((4-(3-hydroxyphenyl)-3,4-dimethyl-1-piperidinyl)methyl)-1-oxo-3-phenylpropyl)-, dihydrate, (3R-(1(S*),3alpha,4alpha))-
Glycine, N-(2-((4-(3-hydroxyphenyl)-3,4-dimethyl-1-piperidinyl)methyl)-1-oxo-3-phenylpropyl)-,dihydrate, (3R-(1(S*),3-alpha,4-alpha))-
Glycine,N-[(2S)-2-[[(3R,4R)-4-(3-hydroxyphenyl)-3,4-dimethyl-1-piperidinyl]methyl]-1-oxo-3-phenylpropyl]-,hydrate (1:2)
GTPL7471
HSDB 7704
HY-13243
HY-76657A
I06-1921
I14-11165
KS-00001EFW
LS-72704
LY 246736
LY 246736 dihydrate
LY-246736 dihydrate
LY246736
MolPort-006-167-841
MolPort-028-744-654
NCGC00378640-02
Q153V49P3Z
RTX-013338
S036
sb-767905
SCHEMBL1477341
SCHEMBL49578
SR-01000945029
SR-01000945029-1
ST24039017
ST24045942
trans-3,4-dimethyl-4-(3-hydroxyphenyl) piperidine
UNII-677C126AET
UNII-Q153V49P3Z
USPVLEIQIUNQGE-DBFLIVQGSA-N
VA10012
W-5224
W-5416
ZINC3802417

US Patents and Regulatory Information for ENTEREG

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Cubist Pharms ENTEREG alvimopan CAPSULE;ORAL 021775-001 May 20, 2008 RX Yes Yes   Start Trial   Start Trial   Start Trial
Cubist Pharms ENTEREG alvimopan CAPSULE;ORAL 021775-001 May 20, 2008 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Cubist Pharms ENTEREG alvimopan CAPSULE;ORAL 021775-001 May 20, 2008 RX Yes Yes   Start Trial   Start Trial   Start Trial
Cubist Pharms ENTEREG alvimopan CAPSULE;ORAL 021775-001 May 20, 2008 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration
Paragraph IV (Patent) Challenges for ENTEREG
Drugname Dosage Strength RLD Date
➤ Subscribe Capsules 12 mg ➤ Subscribe   Start Trial

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