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

2028

2029

2030

2031

2032

2033

2034

2035

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

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Zembrace Symtouch (2023)

Total Spending

$3.0M

Total Claims

1,618

Beneficiaries

363

Avg Cost/Unit

$392.72

Spending Trend

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

YoY Change:+8.1%

5yr CAGR:+3.0%

Source: CMS Medicare Part D Spending by Drug (2023). 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)

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