Esmolol hydrochloride - Generic Drug Details
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What are the generic drug sources for esmolol hydrochloride and what is the scope of freedom to operate?
Esmolol hydrochloride
is the generic ingredient in six branded drugs marketed by Baxter Hlthcare, Am Regent, Amneal, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hq Spclt Pharma, Mylan Institutional, Mylan Labs Ltd, and Sagent Pharms Inc, and is included in thirteen NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Esmolol hydrochloride has seven patent family members in seven countries.
There are five drug master file entries for esmolol hydrochloride. Twelve suppliers are listed for this compound.
Summary for esmolol hydrochloride
International Patents: | 7 |
US Patents: | 2 |
Tradenames: | 6 |
Applicants: | 11 |
NDAs: | 13 |
Drug Master File Entries: | 5 |
Finished Product Suppliers / Packagers: | 12 |
Raw Ingredient (Bulk) Api Vendors: | 96 |
Clinical Trials: | 109 |
Patent Applications: | 1,049 |
Formulation / Manufacturing: | see details |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for esmolol hydrochloride |
What excipients (inactive ingredients) are in esmolol hydrochloride? | esmolol hydrochloride excipients list |
DailyMed Link: | esmolol hydrochloride at DailyMed |
Recent Clinical Trials for esmolol hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Instituto de Salud Carlos III | Phase 3 |
Consorcio Centro de Investigación Biomédica en Red (CIBER) | Phase 3 |
Xiumei Song | Phase 4 |
Pharmacology for esmolol hydrochloride
Drug Class | beta-Adrenergic Blocker |
Mechanism of Action | Adrenergic beta-Antagonists |
Paragraph IV (Patent) Challenges for ESMOLOL HYDROCHLORIDE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
BREVIBLOC IN PLASTIC CONTAINER | Injection | esmolol hydrochloride | 10 mg/mL, 250 mL infusion bags and 20 mg/mL, 100 mL infusion bags | 019386 | 1 | 2014-01-31 |
US Patents and Regulatory Information for esmolol hydrochloride
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Hq Spclt Pharma | ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER | esmolol hydrochloride | SOLUTION;INTRAVENOUS | 205703-001 | Apr 7, 2016 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Mylan Labs Ltd | ESMOLOL HYDROCHLORIDE | esmolol hydrochloride | INJECTABLE;INJECTION | 206608-002 | Jun 8, 2018 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Hq Spclt Pharma | ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER | esmolol hydrochloride | SOLUTION;INTRAVENOUS | 205703-002 | Apr 7, 2016 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
>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 esmolol hydrochloride
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Hq Spclt Pharma | ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER | esmolol hydrochloride | SOLUTION;INTRAVENOUS | 205703-002 | Apr 7, 2016 | ⤷ Try a Trial | ⤷ Try a Trial |
Baxter Hlthcare | BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER | esmolol hydrochloride | INJECTABLE;INJECTION | 019386-005 | Jan 27, 2003 | ⤷ Try a Trial | ⤷ Try a Trial |
Baxter Hlthcare | BREVIBLOC | esmolol hydrochloride | INJECTABLE;INJECTION | 019386-003 | Aug 15, 1988 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for esmolol hydrochloride
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | 2016515513 | 改良軟質プラスチック容器中のすぐに使用可能な共溶媒医薬組成物 | ⤷ Try a Trial |
China | 105263809 | Ready-to-use co-solvents pharmaceutical composition in modified flexible plastic container | ⤷ Try a Trial |
Canada | 2906031 | COMPOSITION PHARMACEUTIQUE DE COSOLVANTS PRETE A L'UTILISATION DANS DES RECIPIENTS DE MATIERE PLASTIQUE FLEXIBLES MODIFIES (READY-TO-USE CO-SOLVENTS PHARMACEUTICAL COMPOSITION IN MODIFIED FLEXIBLE PLASTIC CONTAINER) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
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