Dexmedetomidine hydrochloride - Generic Drug Details
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What are the generic drug sources for dexmedetomidine hydrochloride and what is the scope of freedom to operate?
Dexmedetomidine hydrochloride
is the generic ingredient in three branded drugs marketed by Bioxcel, Accord Hlthcare, Actavis Inc, Am Regent, Amneal, Amneal Pharms Co, Baxter Hlthcare Corp, Endo Operations, Eugia Pharma, Fresenius Kabi Usa, Gland, Gland Pharma Ltd, Hengrui Pharma, Hikma, Meitheal, Milla Pharms, Mylan Institutional, Mylan Labs Ltd, Piramal Critical, Rising, Sandoz, Tagi, Teva Pharms Usa, Wilshire Pharms Inc, Zydus Pharms, Hospira, Hq Spclt Pharma, and Somerset, and is included in thirty-two NDAs. There are twenty-one patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Dexmedetomidine hydrochloride has one hundred and twenty-three patent family members in thirty-seven countries.
There are nine drug master file entries for dexmedetomidine hydrochloride. Twenty-nine suppliers are listed for this compound.
Summary for dexmedetomidine hydrochloride
International Patents: | 123 |
US Patents: | 21 |
Tradenames: | 3 |
Applicants: | 28 |
NDAs: | 32 |
Drug Master File Entries: | 9 |
Finished Product Suppliers / Packagers: | 29 |
Raw Ingredient (Bulk) Api Vendors: | 97 |
Clinical Trials: | 1,344 |
Patent Applications: | 373 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for dexmedetomidine hydrochloride |
What excipients (inactive ingredients) are in dexmedetomidine hydrochloride? | dexmedetomidine hydrochloride excipients list |
DailyMed Link: | dexmedetomidine hydrochloride at DailyMed |
Recent Clinical Trials for dexmedetomidine hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University of Alabama at Birmingham | Phase 1 |
Boston Medical Center | Phase 4 |
Children's Mercy Hospital Kansas City | Phase 4 |
Pharmacology for dexmedetomidine hydrochloride
Drug Class | Central alpha-2 Adrenergic Agonist |
Mechanism of Action | Adrenergic alpha2-Agonists |
Physiological Effect | General Anesthesia |
Medical Subject Heading (MeSH) Categories for dexmedetomidine hydrochloride
Anatomical Therapeutic Chemical (ATC) Classes for dexmedetomidine hydrochloride
Paragraph IV (Patent) Challenges for DEXMEDETOMIDINE HYDROCHLORIDE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
PRECEDEX | Injection | dexmedetomidine hydrochloride | 4 mcg/mL, 20 mL vials | 021038 | 1 | 2015-09-30 |
PRECEDEX | Injection | dexmedetomidine hydrochloride | 4 mcg/mL, 50 mL and 100 mL vials | 021038 | 1 | 2013-12-26 |
PRECEDEX | Injection | dexmedetomidine hydrochloride | 100 mcg/mL | 021038 | 1 | 2009-04-08 |
US Patents and Regulatory Information for dexmedetomidine hydrochloride
Expired US Patents for dexmedetomidine hydrochloride
International Patents for dexmedetomidine hydrochloride
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | 2022550230 | LIDARシステムにおける波長選択 | ⤷ Subscribe |
Canada | 3103431 | FORMULATIONS DE FILM CONTENANT DE LA DEXMEDETOMIDINE ET LEURS PROCEDES DE PRODUCTION (FILM FORMULATIONS CONTAINING DEXMEDETOMIDINE AND METHODS OF PRODUCING THEM) | ⤷ Subscribe |
European Patent Office | 3813828 | MÉTHODES DE TRAITEMENT DE L'AGITATION FAISANT APPEL À DU CHLORHYDRATE DE DEXMÉDÉTOMIDINE (METHODS FOR TREATING AGITATION USING DEXMEDETOMIDINE HYDROCHLORIDE) | ⤷ Subscribe |
Slovenia | 2648520 | ⤷ Subscribe | |
Taiwan | I574688 | ⤷ Subscribe | |
China | 114983981 | 含右美托咪定的膜制剂及其制造方法 (Film formulations containing dexmedetomidine and methods of making same) | ⤷ Subscribe |
Israel | 224867 | ⤷ Subscribe | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for dexmedetomidine hydrochloride
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0300652 | 2003C/005 | Belgium | ⤷ Subscribe | PRODUCT NAME: CHLORHYDRATE DE DEXMEDETOMIDINE; REGISTRATION NO/DATE: EU/2/02/033/001 20020903 |
0300652 | C300117 | Netherlands | ⤷ Subscribe | PRODUCT NAME: DEXMEDETOMIDINE, DESGEWENST IN DE VORM VAN EEN NIET-TOXISCH IN FARMACEUTISCH OPZICHT AANVAARDBAAR ZUURADDITIEZOUT, IN HET BIJZ ONDER DEXMEDETOMIDINE HYDROCHLORIDE; REGISTRATION NO/DATE: EU/2/02/033/001 20020830 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Dexmedetomidine hydrochloride Market Analysis and Financial Projection Experimental
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