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SUMAVEL DOSEPRO

NDA

SUMATRIPTAN SUCCINATE | N022239 | ENDO OPERATIONS LTD

2 strengths2 unique patents0 unique exclusivities

Patent Timeline

2 unique patents by expiration date

Expiring < 1yr (2)Today

Today

7776007

Nov. 22, 2026

7901385

Jul. 31, 2026

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

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

5 letters from Drugs@FDA

Date	Submission	Document
Jul 6, 2020	SUPPL -7	View Letter (PDF)
Dec 27, 2019	SUPPL -6	View Letter (PDF)
Nov 27, 2013	SUPPL -5	View Letter (PDF)
Jul 5, 2011	SUPPL -2	View Letter (PDF)
Jul 20, 2009	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)

RLD

2 patents0 exclusivities▴

INJECTABLE;SUBCUTANEOUS | Approved: Jul 15, 2009

Patents (2)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7776007	Nov 22, 2026	—	—	Yes	—	—
7901385	Jul 31, 2026	—	—	Yes	—	—

#002 — EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)

RLD

0 patents0 exclusivities▾

INJECTABLE;SUBCUTANEOUS | Approved: Nov 26, 2013