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Last Updated: March 28, 2024

Details for Patent: 7,598,343


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Which drugs does patent 7,598,343 protect, and when does it expire?

Patent 7,598,343 protects ANGIOMAX and is included in one NDA.

Protection for ANGIOMAX has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

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 ANGIOMAX bivalirudin INJECTABLE;INTRAVENOUS 020873-001 Dec 15, 2000 AP 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. >Patented / Exclusive Use >Submissiondate

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