Details for Patent: 7,598,343
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Summary for Patent: 7,598,343
Title: | Pharmaceutical formulations of bivalirudin and processes of making the same |
Abstract: | Pharmaceutical batch(es) or pharmaceutical formulation(s) comprising bivalirudin as the active ingredient, and a method of preparing the pharmaceutical batch(es) or pharmaceutical formulation(s). The pharmaceutical batch(es) or pharmaceutical formulation(s) may have a maximum impurity level of Asp.sup.9-bivalirudin that does not exceed about 0.6%. Also, the pharmaceutical batch(es) or pharmaceutical formulation(s) may have a reconstitution time that does not exceed about 42 seconds. The method of preparing the pharmaceutical batch(es) or pharmaceutical formulation(s) may comprise dissolving bivalirudin in a solvent to form a first solution, efficiently mixing a pH-adjusting solution with the first solution to form a second solution in which the pH-adjusting solution may comprise a pH-adjusting solution solvent, and removing the solvent and the pH-adjusting solution solvent from the second solution. |
Inventor(s): | Krishna; Gopal (Parsippany, NJ), Musso; Gary (Parsippany, NJ) |
Assignee: | The Medicines Company (Parsippany, NJ) |
Application Number: | 12/180,551 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for patent 7,598,343 |
Patent Claim Types: see list of patent claims | Composition; Compound; Process; |
Drugs Protected by US Patent 7,598,343
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Patented / Exclusive Use | Submissiondate |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sandoz Inc | ANGIOMAX | bivalirudin | INJECTABLE;INTRAVENOUS | 020873-001 | Dec 15, 2000 | AP | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Patented / Exclusive Use | >Submissiondate |