BIVALIRUDIN IN 0.9% SODIUM CHLORIDE Drug Patent Profile
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When do Bivalirudin In 0.9% Sodium Chloride patents expire, and when can generic versions of Bivalirudin In 0.9% Sodium Chloride launch?
Bivalirudin In 0.9% Sodium Chloride is a drug marketed by Baxter Hlthcare Corp and is included in one NDA.
The generic ingredient in BIVALIRUDIN IN 0.9% SODIUM CHLORIDE is bivalirudin. There are fourteen drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the bivalirudin profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Bivalirudin In 0.9% Sodium Chloride
A generic version of BIVALIRUDIN IN 0.9% SODIUM CHLORIDE was approved as bivalirudin by FRESENIUS KABI USA on October 28th, 2016.
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Summary for BIVALIRUDIN IN 0.9% SODIUM CHLORIDE
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Clinical Trials: | 72 |
| What excipients (inactive ingredients) are in BIVALIRUDIN IN 0.9% SODIUM CHLORIDE? | BIVALIRUDIN IN 0.9% SODIUM CHLORIDE excipients list |
| DailyMed Link: | BIVALIRUDIN IN 0.9% SODIUM CHLORIDE at DailyMed |
Recent Clinical Trials for BIVALIRUDIN IN 0.9% SODIUM CHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Sydney Local Health District | Phase 2 |
| Veralox Therapeutics | Phase 2 |
| University Magna Graecia | N/A |
US Patents and Regulatory Information for BIVALIRUDIN IN 0.9% SODIUM CHLORIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baxter Hlthcare Corp | BIVALIRUDIN IN 0.9% SODIUM CHLORIDE | bivalirudin | SOLUTION;INTRAVENOUS | 208374-001 | Dec 21, 2017 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Baxter Hlthcare Corp | BIVALIRUDIN IN 0.9% SODIUM CHLORIDE | bivalirudin | SOLUTION;INTRAVENOUS | 208374-002 | Dec 21, 2017 | DISCN | Yes | 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 |
EU/EMA Drug Approvals for BIVALIRUDIN IN 0.9% SODIUM CHLORIDE
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| The Medicines Company UK Ltd | Angiox | bivalirudin | EMEA/H/C/000562 Angiox is indicated as an anticoagulant in adult patients undergoing percutaneous coronary intervention (PCI), including patients with ST-segment-elevation myocardial infarction (STEMI) undergoing primary PCI.Angiox is also indicated for the treatment of adult patients with unstable angina / non-ST-segment-elevation myocardial infarction (UA / NSTEMI) planned for urgent or early intervention.Angiox should be administered with aspirin and clopidogrel. |
Withdrawn | no | no | no | 2004-09-20 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
