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ATZUMI

NDA

DIHYDROERGOTAMINE MESYLATE | N217901 | SATSUMA PHARMACEUTICALS INC

1 strength7 unique patents1 unique exclusivity

Patent Timeline

7 unique patents, 1 exclusivity by expiration date

Active (7)TodayExclusivity

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

2038

2039

2040

2041

2042

Today

Dec. 11, 2039

Aug. 4, 2037

Oct. 12, 2041

Aug. 4, 2037

Oct. 12, 2041

Dec. 11, 2039

Sep. 24, 2033

Apr. 30, 2028

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 Chain4 active DMFs2 inactive

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

TAPI NL BVDIHYDROERGOTAMINE MESYLATE

DMF 149442000

CURIA ITALY SRLDIHYDROERGOTAMINE MESYLATE USP/EP

DMF 224072009

OLON SPADIHYDROERGOTAMINE MESYLATE

DMF 304972016

OLON SPADIHYDROERGOTAMINE MESYLATE

DMF 330222018

BOEHRINGER INGELHEIM PHARMA GMBH AND CO KGInactiveDIHYDROERGOTAMINE MESYLATE

DMF 102421993

LEK PHARMACEUTICALS DDInactiveDIHYDROERGOTAMINE MESYLATE

DMF 161942002

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
May 5, 2025	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 5.2MG BASE

RLD

7 patents1 exclusivity▴

POWDER;NASAL | Approved: Apr 30, 2025

Patents (7)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
10758532	Dec 11, 2039	—	—	Yes	—	—
10792253	Aug 4, 2037	—	—	Yes	—	—
11744967	Oct 12, 2041	—	—	Yes	—	—
11872314	Aug 4, 2037	—	—	Yes	—	—
12102754	Oct 12, 2041	—	—	Yes	—	—
12263162	Dec 11, 2039	—	—	Yes	—	—
12594273	Sep 24, 2033	—	—	Yes	—	—

Exclusivities (1)

Code	Date	Status
NP	Apr 30, 2028	Active