Viewing data from:

ZEMBRACE SYMTOUCH

NDA

SUMATRIPTAN SUCCINATE | N208223 | TONIX MEDICINES INC

1 strength3 unique patents0 unique exclusivities

Patent Timeline

3 unique patents by expiration date

Active (3)Today

2027

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2036

Today

10537554

Jan. 29, 2036

11364224

Jan. 29, 2036

12097183

Jan. 29, 2036

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

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

86 trials from ClinicalTrials.gov, 78 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Study Of Sumatriptan Succinate Injection Kit In Patients With Migraine or Cluster Headache In Japan NCT00356603	Phase 3	Completed	GlaxoSmithKline	75	2006-06-20 → 2006-08-07
Comparing Naproxen to Sumatriptan for Emergency Headache Patients NCT00449787	Phase 4	Completed	Montefiore Medical Center	401	2007-03 → 2009-07
Migraine Study in Adolescent Patients NCT00843024	Phase 3	Completed	GlaxoSmithKline	589	2008-12 → 2010-06
Effect of Sumatriptan on the Postoperative Quality of Recovery After Elective Minimally Invasive Craniotomy NCT01632657	N/A	Completed	University Health Network, Toronto	40	2012-06 → 2019-12-15
Treximet (Sumatriptan/Naproxen Sodium), Formerly Known as TREXIMA, for Menstrual Migraine in Women With Dysmenorrhea NCT00329459	Phase 3	Completed	GlaxoSmithKline	320	2006-05 → 2006-11
Sumatriptan Succinate 100 mg Tablets Under Non-Fasting Conditions NCT00846885	Phase 1	Completed	Teva Pharmaceuticals USA	28	2004-08 → 2004-10
Bioequivalence Study of Sumatriptan 100mg Tablets Under Fed Conditions NCT00872274	N/A	Completed	Ranbaxy Laboratories Limited	32	2008-07 → 2008-09
"Completeness of Response" Following Treatment With Treximet™ for Migraine NCT00893737	Phase 4	Completed	Cady, Roger, M.D.	147	2009-06 → 2010-01
To Evaluate the Safety and Efficacy of Trexima in the Acute Treatment of Migraine Headaches NCT00433732	Phase 3	Completed	POZEN	1,400	2004-08 → 2005-04
Bioequivalence Study of Sumatriptan 100mg Tablets Under Fasting Conditions NCT00872924	N/A	Completed	Ranbaxy Laboratories Limited	32	2008-07 → 2008-09

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 2 NDCs

Highest NADAC/Unit

$384.14

per ml

Lowest NADAC/Unit

$384.14

per ml

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
70792080938ZEMBRACE SYMTOUCH 3 MG/0.5 ML	$384.14	ML	Brand	—	2026-06-17
00245080938ZEMBRACE SYMTOUCH 3 MG/0.5 ML	$384.14	ML	Brand	—	2026-06-17

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

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (2 FSS)

Lowest Price

$502.12

Highest Price

$549.75

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
70792-0809-38ZEMBRACE SYMTOUCH 3MG/0.5ML INJ,PEN,0.5ML	$549.75	FSS	Tonix Medicines, Inc.	07/31/2029
00245-0809-38ZEMBRACE SYMTOUCH 3MG/0.5ML INJ,PEN,0.5ML	$502.12	FSS	Tonix Medicines, Inc.	07/31/2029

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

Medicare Part D Spending

CMS annual spending data for Zembrace Symtouch (2024)

Total Spending

$2.5M

Total Claims

1,408

Beneficiaries

342

Avg Cost/Unit

$379.30

Spending Trend

$3.0M(2019)→$3.0M(2020)→$2.7M(2021)→$2.8M(2022)→$3.0M(2023)→$2.5M(2024)

YoY Change:-3.4%

5yr CAGR:+1.9%

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

API Supply Chain15 active DMFs4 inactive

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

QUIMICA SINTETICA SASUMATRIPTAN SUCCINATE

DMF 153762001

DR REDDYS LABORATORIES LTDSUMATRIPTAN SUCCINATE

DMF 165342003

NATCO PHARMA LTDSUMATRIPTAN SUCCINATE

DMF 169302003

MOEHS IBERICA SLSUMATRIPTAN SUCCINATE

DMF 173522004

APITORIA PHARMA PRIVATE LTDSUMATRIPTAN SUCCINATE USP

DMF 193302006

ORBION PHARMACEUTICALS PRIVATE LTDSUMATRIPTAN SUCCINATE

DMF 193402006

SUN PHARMACEUTICAL INDUSTRIES LTDSUMATRIPTAN SUCCINATE USP

DMF 193722006

SMS PHARMACEUTICALS LTDSUMATRIPTAN SUCCINATE (ALTERNATIVE SYNTHESIS)

DMF 207462007

NATCO PHARMA LTDSUMATRIPTAN SUCCINATE (INJECTABLE GRADE)

DMF 208942007

MATRIX PHARMACORP PRIVATE LTDSUMATRIPTAN SUCCINATE USP

DMF 217112008

MSN PHARMACHEM PRIVATE LTDSUMATRIPTAN SUCCINATE USP [ROUTE CODE - "SU"]

DMF 224822009

DIVIS LABORATORIES LTDSUMATRIPTAN SUCCINATE AND SUMATRIPTAN

DMF 236242010

APITORIA PHARMA PRIVATE LTDSUMATRIPTAN SUCCINATE USP (PROCESS II)

DMF 322182017

CHROMO LABORATORIES INDIA PRIVATE LTDSUMATRIPTAN SUCCINATE USP

DMF 369722022

DR REDDYS LABORATORIES LTDSUMATRIPTAN SUCCINATE USP

DMF 375512022

SMS PHARMACEUTICALS LTDInactiveSUMATRIPTAN SUCCINATE

DMF 162792002

CIPLA LTDInactiveSUMATRIPTAN SUCCINATE USP

DMF 173972004

APOTEX PHARMACHEM INCInactiveSUMATRIPTAN SUCCINATE USP

DMF 230792009

ASYMCHEM LIFE SCIENCE TIANJIN CO LTDInactiveSUMATRIPTAN SUCCINATE

DMF 285902014

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

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Jun 12, 2019	SUPPL -5	View Letter (PDF)
Mar 28, 2017	SUPPL -3	View Letter (PDF)
Feb 1, 2016	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)

RLD

3 patents0 exclusivities▴

SOLUTION;SUBCUTANEOUS | Approved: Jan 28, 2016

Patents (3) · 2 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
10537554	Jan 29, 2036	—	—	—		—
11364224	Jan 29, 2036	—	—	—		—
12097183	Jan 29, 2036	—	—	Yes	—	—