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Last Updated: January 28, 2020

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Eletriptan hydrobromide - Generic Drug Details

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What are the generic drug sources for eletriptan hydrobromide and what is the scope of freedom to operate?

Eletriptan hydrobromide is the generic ingredient in two branded drugs marketed by Ajanta Pharma Ltd, Amneal Pharms Co, Aurobindo Pharma Ltd, Mylan, Teva Pharms Usa, Zydus Pharms, and Pfizer Ireland, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.

There are twelve drug master file entries for eletriptan hydrobromide. Eleven suppliers are listed for this compound. There is one tentative approval for this compound.

Recent Clinical Trials for eletriptan hydrobromide

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

SponsorPhase
PfizerPhase 1

See all eletriptan hydrobromide clinical trials

Recent Litigation for eletriptan hydrobromide

Identify potential future generic entrants

District Court Litigation
Case NameDate
Valeant International, Bermuda v. Watson Pharmaceuticals Inc.2010-02-19

See all eletriptan hydrobromide litigation

Generic filers with tentative approvals for ELETRIPTAN HYDROBROMIDE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial40MGTABLET; ORAL
  Start Trial  Start Trial20MGTABLET; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Synonyms for eletriptan hydrobromide
(R)-3-((1-Methyl-2-pyrrolidinyl)methyl)-5-(2-(phenylsulfonyl)ethyl)-1H-indole monohydrobromide
(R)-3-((1-Methylpyrrolidin-2-yl)methyl)-5-(2-(phenylsulfonyl)ethyl)-1H-indole hydrobromide
(r)-3-[(1-methyl-2-pyrrolidinyl) methyl]-5-[2-(phenylsulfonyl) ethyl]-1h-indole monohydrobromide
(R)-5-[2-(Benzenesulfonyl)ethyl]-3-[(N-methylpyrrolidin-2-yl)methyl]-1H-indole Hydrobromide
177834-92-3
1H-Indole, 3-(((2R)-1-methyl-2-pyrrolidinyl))methyl)-5-(2-(phenylsulfonyl)ethyl)-, monohydrobromide
3-(((R)-1-Methyl-2-pyrrolidinyl)methyl)-5-(2-(phenylsulfonyl)ethyl)indole, monohydrobromide
3-(N-methyl-2(R)-pyrrolidinyl methyl)-5-[2-(phenyl sulfonyl)ethyl]-1H-indole hydrobromide
3-(N-Methyl-2(R)-pyrrolidinylmethyl)-5-(2-phenylsulphonylethly)-1H-indole hydrobromide
3-(N-Methyl-2(R)-pyrrolidinylmethyl)-5-(2-phenylsulphonylethyl)-1H-indole hydrobromide
3-(N-methyl-2(R)-pyrrolidinylmethyl)-5-[2-(phenyl sulfonyl)ethyl]-1H-indole hydrobromide
3-[[(2R)-1-Methyl-2-pyrrolidinyl]methyl]-5-[2-(phenylsulfonyl)ethyl]-1H-indole Hydrobromide
3-[[(2R)-1-methylpyrrolidin-2-yl]methyl]-5-[2-(phenylsulfonyl)ethyl]-1H-indole hydrobromide
3-{[1-Methylpyrrolidin-2(R)-yl]methyl}-5-(2-phenylsulphonylethyl)-1H-indole hydrobromide
5-[2-(benzenesulfonyl)ethyl]-3-[[(2R)-1-methyl-2-pyrrolidinyl]methyl]-1H-indole hydrobromide
5-[2-(benzenesulfonyl)ethyl]-3-[[(2R)-1-methylpyrrolidin-2-yl]methyl]-1H-indole hydrobromide
5-[2-(benzenesulfonyl)ethyl]-3-[[(2R)-1-methylpyrrolidin-2-yl]methyl]-1H-indole;hydrobromide
5-[2-(phenylsulfonyl)ethyl]-3-[(2R)-pyrrolidin-2-ylmethyl]-1H-indole hydrobromide
A812302
AC-3398
AC1LCVBD
AKOS024262728
API0008562
BCP9000640
C22H26N2O2S.HBr
CCG-221712
CHEBI:61176
CHEMBL1201003
CS-0379
D01973
Eletriptan HBr
Eletriptan hydrobromide (JAN/USAN)
Eletriptan Hydrobromide [USAN]
Eletriptan hydrobromide, >=98% (HPLC)
Eletriptan hydrobromide; 1H-Indole,3-[(1-methyl-2-pyrrolidinyl)methyl]-5-[2-(phenylsulfonyl)ethyl]-,monohydrobromide, (R)-
Eletriptan hydrobromide|177834-92-3
eletriptan monohydrobromide
HY-A0010
J-011323
J-520433
M41W832TA3
MolPort-019-993-155
NCGC00261093-01
Relert
Relpax (TN)
RelpaxAlso see: E505000
RL02268
s3180
SC-26797
SCHEMBL317370
ST24035397
SW220149-1
Tox21_500408
UK 116044-04
UK-116,044-04
UK-11604404
UNII-M41W832TA3
UTINOWOSWSPFLJ-FSRHSHDFSA-N
Paragraph IV (Patent) Challenges for ELETRIPTAN HYDROBROMIDE
Tradename Dosage Ingredient NDA Submissiondate
RELPAX TABLET;ORAL eletriptan hydrobromide 021016 2010-03-29

US Patents and Regulatory Information for eletriptan hydrobromide

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Aurobindo Pharma Ltd ELETRIPTAN HYDROBROMIDE eletriptan hydrobromide TABLET;ORAL 210708-001 Jan 15, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Amneal Pharms Co ELETRIPTAN HYDROBROMIDE eletriptan hydrobromide TABLET;ORAL 206787-001 May 25, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Pfizer Ireland RELPAX eletriptan hydrobromide TABLET;ORAL 021016-001 Dec 26, 2002 AB RX 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

Expired US Patents for eletriptan hydrobromide

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer Ireland RELPAX eletriptan hydrobromide TABLET;ORAL 021016-001 Dec 26, 2002   Start Trial   Start Trial
Pfizer Ireland RELPAX eletriptan hydrobromide TABLET;ORAL 021016-001 Dec 26, 2002   Start Trial   Start Trial
Pfizer Ireland RELPAX eletriptan hydrobromide TABLET;ORAL 021016-002 Dec 26, 2002   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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AstraZeneca

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