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RELPAX

NDA

ELETRIPTAN HYDROBROMIDE | N021016 | UPJOHN MANUFACTURING IRELAND UNLTD

2 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

6 trials from ClinicalTrials.gov, 6 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Zolmitriptan Nasal Spray Versus Eletriptan in the Acute Treatment of Migraine NCT01276977	N/A	Completed	California Medical Clinic for Headache	80	2008-04 → 2010-12
Eletriptan vs Sumatriptan: A Double-blind, Placebo-controlled, Multiple Migraine Attack Study NCT01986088	Phase 3	Completed	Pfizer's Upjohn has merged with Mylan to form Viatris Inc.	1,008	1996-11 → 1998-01
Eletriptan Pharmacokinetics In Korean Males NCT01139515	Phase 1	Completed	Pfizer's Upjohn has merged with Mylan to form Viatris Inc.	16	2010-07 → 2010-07
Does Treximet Improve Productivity and Patient Satisfaction Due to Sustained Response and Consistency of Response?NCT01086358	Phase 4	Completed	The Cleveland Clinic	60	2009-09 → 2016-08
Comparative Study of Oral Eletriptan (40mg and 80mg), Oral Sumatriptan (25mg and 50mg) and Placebo NCT01986270	Phase 3	Completed	Pfizer's Upjohn has merged with Mylan to form Viatris Inc.	1,141	1996-12 → 1998-01
Eletriptan for the Treatment of Migraine in Patients With Previous Poor Response or Tolerance to Oral Sumatriptan NCT01989936	Phase 3	Completed	Pfizer's Upjohn has merged with Mylan to form Viatris Inc.	446	1999-01 → 2000-09

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-10-21 | 3 NDCs

Highest NADAC/Unit

$77.37

per ea

Lowest NADAC/Unit

$77.08

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
58151036756RELPAX 20 MG TABLET	$77.37	EA	Brand	$1.59	2026-10-21
58151036856RELPAX 40 MG TABLET	$77.08	EA	Brand	$1.76	2026-10-21
58151036896RELPAX 40 MG TABLET	$77.08	EA	Brand	$1.76	2026-10-21

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 8 NDCs (4 FSS, 4 Big4)

Lowest Price

$273.47

Highest Price

$546.93

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00049-2330-45RELPAX 20MG TAB	$273.47	Big4	Mylan Specialty L.P.	01/14/2027
00049-2330-45RELPAX 20MG TAB	$273.47	FSS	Mylan Specialty L.P.	01/14/2027
58151-0367-56RELPAX 20MG TAB	$273.47	Big4	Mylan Specialty L.P.	01/14/2027
58151-0367-56RELPAX 20MG TAB	$273.47	FSS	Mylan Specialty L.P.	01/14/2027
58151-0368-56RELPAX 40MG TAB	$273.47	Big4	Mylan Specialty L.P.	01/14/2027
58151-0368-56RELPAX 40MG TAB	$273.47	FSS	Mylan Specialty L.P.	01/14/2027
58151-0368-96RELPAX 40MG TAB	$546.93	Big4	Mylan Specialty L.P.	01/14/2027
58151-0368-96RELPAX 40MG TAB	$546.93	FSS	Mylan Specialty L.P.	01/14/2027

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Relpax (2024)

Total Spending

$2.8M

Total Claims

2,201

Beneficiaries

449

Avg Cost/Unit

$77.50

Spending Trend

$4.4M(2019)→$4.0M(2020)→$3.5M(2021)→$3.1M(2022)→$3.1M(2023)→$2.8M(2024)

YoY Change:-0.2%

5yr CAGR:+4.7%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain10 active DMFs2 inactive

8 active API suppliers hold Drug Master Files for this ingredient.

TAPI NL BVELETRIPTAN HYDROBROMIDE

DMF 229122009

MATRIX PHARMACORP PRIVATE LTDELETRIPTAN HYDROBROMIDE (PROCESS 1)

DMF 245042010

FIS FABBRICA ITALIANA SINTETICI SPAELETRIPTAN HYDROBROMIDE

DMF 245282010

SMS PHARMACEUTICALS LTDELETRIPTAN HYDROBROMIDE MONOHYDRATE

DMF 249052011

MATRIX PHARMACORP PRIVATE LTDELETRIPTAN HYDROBROMIDE (PROCESS 2)

DMF 250762011

HETERO DRUGS LTDELETRIPTAN HYDROBROMIDE

DMF 260992012

YUNG SHIN PHARMACEUTICAL INDUSTRIAL CO LTDELETRIPTAN HYDROBROMIDE "YUNG SHIN"

DMF 296162015

TIANJIN WEIJIE PHARMACEUTICAL CO LTDELETRIPTAN HYDROBROMIDE

DMF 303382016

APITORIA PHARMA PRIVATE LTDELETRIPTAN HYDROBROMIDE

DMF 313362017

SMS PHARMACEUTICALS LTDELETRIPTAN HYDROBROMIDE

DMF 421282025

APOTEX PHARMACHEM INDIA PVT LTDInactiveELETRIPTAN HYDROBROMIDE

DMF 236512010

VIWIT PHARMACEUTICAL CO LTDInactiveELETRIPTAN HYDROBROMIDE (DRUG SUBSTANCE, NON-STERILE)

DMF 270692013

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

9 letters from Drugs@FDA

Date	Submission	Document
Oct 8, 2013	SUPPL -21	View Letter (PDF)
Oct 8, 2013	SUPPL -24	View Letter (PDF)
Oct 8, 2013	SUPPL -27	View Letter (PDF)
Oct 8, 2013	SUPPL -23	View Letter (PDF)
Apr 15, 2011	SUPPL -18	View Letter (PDF)
Jul 23, 2010	SUPPL -9	View Letter (PDF)
Jul 23, 2010	SUPPL -16	View Letter (PDF)
May 7, 2004	SUPPL -3	View Letter (PDF)
Jan 29, 2003	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 20MG BASE

RLDAB

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Dec 26, 2002

No patent or exclusivity listings for this strength.

#002 — EQ 40MG BASE

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Dec 26, 2002