FDA Orange Book · active-ingredient family
Dihydroergotamine mesylate
Dihydroergotamine mesylate: 5 brands, 13 generics; first approved Dec 08, 1997; generic available.
Generic available1 exclusivity periodHas discontinued products
Generic status & protection
Generic available: 13 ANDA applications approved.
Earliest patent expiry Latest exclusivity ends
Brands (NDA)
5
Generics (ANDA)
13
Listed patents
21
Next patent expiry
Sep 05, 2032
in 6 yr 2 mo
Brand (NDA) products
Originator applications
- AMNEALNDA 2154002025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML SOLUTION SUBCUTANEOUS Rx — - SATSUMA PHARMSNDA 2179012025
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5.2MG BASE POWDER NASAL Rx — - IMPEL PHARMSNDA 2134362021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.725MG/SPRAY SPRAY, METERED NASAL Rx — - BAUSCHNDA 0201481997
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG/SPRAY SPRAY, METERED NASAL Rx AB - D.H.E. 45RLDBAUSCHNDA 005929—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Discontinued —
Generic (ANDA) products (13)
Abbreviated applications
- DIHYDROERGOTAMINE MESYLATESOMERSET THERAPS LLCANDA 2152282025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG/SPRAY SPRAY, METERED NASAL Rx AB - DIHYDROERGOTAMINE MESYLATEBAXTER HLTHCARE CORPANDA 2167472025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Discontinued — - DIHYDROERGOTAMINE MESYLATECIPLAANDA 2123342024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Discontinued — - DIHYDROERGOTAMINE MESYLATEGLANDANDA 2156232023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Rx AP - DIHYDROERGOTAMINE MESYLATERUBICON RESEARCHANDA 2168812023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG/SPRAY SPRAY, METERED NASAL Rx AB - DIHYDROERGOTAMINE MESYLATEAMNEALANDA 2141052022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG/SPRAY SPRAY, METERED NASAL Discontinued — - DIHYDROERGOTAMINE MESYLATECIPLAANDA 2129072020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG/SPRAY SPRAY, METERED NASAL Rx AB - DIHYDROERGOTAMINE MESYLATEHIKMAANDA 2113932020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG/SPRAY SPRAY, METERED NASAL Rx AB - DIHYDROERGOTAMINE MESYLATEMILLA PHARMSANDA 2120462020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Rx AP - DIHYDROERGOTAMINE MESYLATESAGENT PHARMS INCANDA 2072642018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Rx AP - DIHYDROERGOTAMINE MESYLATERSHIKMA PHARMSANDA 2066212017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Rx AP - DIHYDROERGOTAMINE MESYLATEHIKMAANDA 0404532003
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Rx AP - DIHYDROERGOTAMINE MESYLATEPADAGIS USANDA 0404752003
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Discontinued —
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Marketing exclusivity
Hatch-Waxman
- NPNew product exclusivity (3 years)
in 1 yr 9 mo
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 9550036 | in 6 yr 2 mo | Product | |
| 10507295 | in 6 yr 6 mo | Product | |
| 10940278 | in 6 yr 7 mo | Product | |
| 9919117 | in 6 yr 8 mo | ProductU-3218 | |
| 12594273 | in 7 yr 3 mo | Product | |
| 11266799 | in 10 yr 5 mo | Product | |
| 11872314 | in 11 yr 2 mo | Product | |
| 10792253 | in 11 yr 2 mo | Product | |
| 11185497 | in 12 yr 7 mo | U-3218 | |
| 11819501 | in 12 yr 9 mo | U-848 | |
| 10532049 | in 12 yr 9 mo | Product | |
| 12533351 | in 12 yr 9 mo | Product | |
| 11304942 | in 12 yr 9 mo | Product | |
| 11541043 | in 12 yr 9 mo | Product | |
| 12329749 | in 13 yr | ProductU-2718 | |
| 11083712 | in 13 yr 1 mo | ProductU-2718 | |
| 12414941 | in 13 yr 3 mo | Product | |
| 10758532 | in 13 yr 6 mo | Product | |
| 12263162 | in 13 yr 6 mo | Product | |
| 12102754 | in 15 yr 5 mo | Product | |
| 11744967 | in 15 yr 5 mo | Product |
Approval history
FDA approval span
First approval
29 yr 1 mo ago
Most recent approval
1 yr 3 mo ago
Approvals span 1997–2025 across 18 FDA applications.
Brand (NDA) 528%
Generic (ANDA) 1372%
Dihydroergotamine mesylate: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
