Dihydroergotamine mesylate - Generic Drug Details
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What are the generic drug sources for dihydroergotamine mesylate and what is the scope of freedom to operate?
Dihydroergotamine mesylate
is the generic ingredient in five branded drugs marketed by Bausch, Cipla, Gland Pharma Ltd, Hikma, Hikma Pharms, Padagis Us, Provepharm Sas, Sagent Pharms Inc, Amneal, Rubicon, Impel Pharms, and Novartis, and is included in fifteen NDAs. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.Dihydroergotamine mesylate has sixty-four patent family members in sixteen countries.
There are six drug master file entries for dihydroergotamine mesylate. Ten suppliers are listed for this compound.
Summary for dihydroergotamine mesylate
| International Patents: | 64 |
| US Patents: | 6 |
| Tradenames: | 5 |
| Applicants: | 12 |
| NDAs: | 15 |
| Drug Master File Entries: | 6 |
| Finished Product Suppliers / Packagers: | 10 |
| Raw Ingredient (Bulk) Api Vendors: | 48 |
| Clinical Trials: | 16 |
| Patent Applications: | 1,945 |
| Drug Prices: | Drug price trends for dihydroergotamine mesylate |
| What excipients (inactive ingredients) are in dihydroergotamine mesylate? | dihydroergotamine mesylate excipients list |
| DailyMed Link: | dihydroergotamine mesylate at DailyMed |
Recent Clinical Trials for dihydroergotamine mesylate
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Ache Laboratorios Farmaceuticos S.A. | Phase 3 |
| Xijing Hospital | Phase 2/Phase 3 |
| Satsuma Pharmaceuticals, Inc. | Phase 3 |
Pharmacology for dihydroergotamine mesylate
| Drug Class | Ergotamine Derivative |
Medical Subject Heading (MeSH) Categories for dihydroergotamine mesylate
Anatomical Therapeutic Chemical (ATC) Classes for dihydroergotamine mesylate
US Patents and Regulatory Information for dihydroergotamine mesylate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Cipla | DIHYDROERGOTAMINE MESYLATE | dihydroergotamine mesylate | SPRAY, METERED;NASAL | 212907-001 | May 20, 2020 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Amneal | DIHYDROERGOTAMINE MESYLATE | dihydroergotamine mesylate | SPRAY, METERED;NASAL | 214105-001 | Jan 4, 2022 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Padagis Us | DIHYDROERGOTAMINE MESYLATE | dihydroergotamine mesylate | INJECTABLE;INJECTION | 040475-001 | Apr 28, 2003 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Sagent Pharms Inc | DIHYDROERGOTAMINE MESYLATE | dihydroergotamine mesylate | INJECTABLE;INJECTION | 207264-001 | Jul 11, 2018 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Cipla | DIHYDROERGOTAMINE MESYLATE | dihydroergotamine mesylate | INJECTABLE;INJECTION | 212334-001 | Sep 20, 2024 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Impel Pharms | TRUDHESA | dihydroergotamine mesylate | SPRAY, METERED;NASAL | 213436-001 | Sep 2, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Novartis | EMBOLEX | dihydroergotamine mesylate; heparin sodium; lidocaine hydrochloride | INJECTABLE;INJECTION | 018885-002 | Nov 30, 1984 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for dihydroergotamine mesylate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Bausch | MIGRANAL | dihydroergotamine mesylate | SPRAY, METERED;NASAL | 020148-001 | Dec 8, 1997 | ⤷ Sign Up | ⤷ Sign Up |
| Bausch | MIGRANAL | dihydroergotamine mesylate | SPRAY, METERED;NASAL | 020148-001 | Dec 8, 1997 | ⤷ Sign Up | ⤷ Sign Up |
| Bausch | MIGRANAL | dihydroergotamine mesylate | SPRAY, METERED;NASAL | 020148-001 | Dec 8, 1997 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for dihydroergotamine mesylate
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| South Korea | 20200118032 | 정밀 후각기관 장치에 의한 디하이드로에르고타민의 비강내 전달 | ⤷ Sign Up |
| China | 103619485 | Nozzles for nasal drug delivery | ⤷ Sign Up |
| Japan | 2018527099 | 直列形経鼻送達デバイス | ⤷ Sign Up |
| Japan | 6959708 | ⤷ Sign Up | |
| Canada | 3088942 | ADMINISTRATION INTRANASALE DE DIHYDROERGOTAMINE PAR UN DISPOSITIF OLFACTIF DE PRECISION (INTRANASAL DELIVERY OF DIHYDROERGOTAMINE BY PRECISION OLFACTORY DEVICE) | ⤷ Sign Up |
| South Africa | 201801543 | IN-LINE NASAL DELIVERY DEVICE | ⤷ Sign Up |
| World Intellectual Property Organization (WIPO) | 2019136291 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
ISSN: 2162-2639
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