BEROTRALSTAT DIHYDROCHLORIDE | N219776 | BIOCRYST PHARMACEUTICALS INC
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| 10125102 | Apr 7, 2035 | — | Yes | — | U-4535 | — |
| 10329260 | Mar 9, 2035 | — | Yes | — | — | — |
| 10662160 | Nov 1, 2039 | — | Yes | — | U-4535 | — |
| 10689346 | Mar 9, 2035 | — | — | — | U-4535 | — |
| 11117867 | Nov 1, 2039 | — | — | Yes | U-4535 | — |
| 11230530 | Mar 9, 2035 | — | — | — | U-4535 | — |
| 11618733 | Nov 1, 2039 | — | — | — | U-4535 | — |
| 11708333 | Mar 9, 2035 | — | — | — | U-4535 | — |
| 12116346 | Mar 9, 2035 | — | Yes | — | — | — |
| 12344585 | Nov 1, 2039 | — | — | — | U-4535 | — |
| 12545645 | Nov 1, 2039PED: May 1, 2040 | PED | Yes | Yes | — | — |
| 12545646 | Nov 1, 2039PED: May 1, 2040 | PED | Yes | Yes | — | — |
| 12545647 | Nov 1, 2039PED: May 1, 2040 | PED | Yes | Yes | — | — |
| 12552750 | Nov 1, 2039PED: May 1, 2040 | PED | Yes | Yes | — | — |
| 12590068 | Nov 1, 2039PED: May 1, 2040 | PED | Yes | Yes | — | — |
| 12590069 | Nov 1, 2039PED: May 1, 2040 | PED | Yes | Yes | — | — |
| Code | Date | Status |
|---|---|---|
| NP | Dec 11, 2028 | Active |
| PED | Jun 11, 2029 | Active |
BioKryst added U.S. Patent 12,344,585 to the Orange Book for Orladeyo (berotralstat dihydrochloride), listing patent expiration in 2044.
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BioRyst added U.S. Patent 11,117,867 to the Orange Book for berotralstat dihydrochloride (ORLADEYO).
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BioRyst added U.S. Patent 11,708,333 to the Orange Book for Orladeyo (berotralstat dihydrochloride), extending patent protection for NDA 219776.
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Biocryst added U.S. Patent 11,117,867 to the Orange Book for Orladeyo (berotralstat dihydrochloride), NDA 219776.
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BioBlast BioBlast BioBlast added U.S. Patent 10,125,102 to the Orange Book listing for Orladeyo (berotralstat dihydrochloride), expanding the patent protections for this plasma kallikrein inhibitor.
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BioDelivery Sciences added US Patent 12,116,346 to the Orange Book for Orladeyo (berotralstat dihydrochloride) NDA 219776.
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BIOCRYST added U.S. patent 10,662,160 to the Orange Book listing for ORLADEYO (berotralstat dihydrochloride), NDA 219776.
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BioGiaxys added U.S. Patent 10,662,160 to the Orange Book for Orladeyo (berotralstat dihydrochloride) under NDA 219776.
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BioKryst added U.S. Patent 10,329,260 to the Orange Book for Orladeyo (berotralstat dihydrochloride) NDA 219776.
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BioKryst added U.S. Patent 11,618,733 to the Orange Book for Orladeyo (berotralstat dihydrochloride), extending patent protection for the drug.
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BIOCRYST added patent '10662160' to the Orange Book listing for ORLADEYO (berotralstat dihydrochloride) for NDA 219776.
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Berotralstat dihydrochloride (Orladeyo) NDA 219776 now lists U.S. Patent 10,329,260 in the Orange Book.
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BioRyst added U.S. Patent 12,116,346 to the Orange Book for Orladeyo (berotralstat dihydrochloride) NDA 219776.
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BIOCRYST added U.S. Patent 10329260 to the Orange Book listing for Orladeyo (berotralstat dihydrochloride), NDA 219776.
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Biocryst added U.S. Patent 10,125,102 to the Orange Book for Orladeyo (berotralstat dihydrochloride) NDA 219776.
New: New record
BioKryst added U.S. Patent 12,116,346 to the Orange Book for Orladeyo (berotralstat dihydrochloride), extending patent protection for the NDA 219776 formulation.
New: New record
BioRyst added U.S. Patent 10,689,346 to the Orange Book for Orladeyo (berotralstat dihydrochloride) NDA 219776.
New: New record
BioRyst added U.S. Patent 11,708,333 to the Orange Book for Orladeyo (berotralstat dihydrochloride), extending patent protection for the approved indication.
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BioKryst added US Patent 10,329,260 to the Orange Book for Orladeyo (berotralstat dihydrochloride), listed against NDA 219776.
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BioRyst added U.S. Patent 11,618,733 to the Orange Book for Orladeyo (berotralstat dihydrochloride), listing expiration in Dec 2042.
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BioCryst added U.S. Patent 11,708,333 to the Orange Book for Orladeyo (berotralstat dihydrochloride), extending patent protection for the NDA 219776 formulation.
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BioRyst added U.S. Patent 11,708,333 to the Orange Book for Orladeyo (berotralstat dihydrochloride) NDA 219776.
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BioRyst added U.S. Patent 11,230,530 to the Orange Book for Orladeyo (berotralstat dihydrochloride), expanding the patent protection listed against the NDA 219776 formulation.
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BioRyst added U.S. Patent 10,689,346 to the Orange Book for Orladeyo (berotralstat dihydrochloride), potentially blocking generic competition until the patent's expiration date.
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Biocryst listed U.S. Patent 12,344,585 in the Orange Book for Orladeyo (berotralstat dihydrochloride) under NDA 219776.
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BioRyst added US Patent 12,116,346 to the Orange Book for Orladeyo (berotralstat dihydrochloride), listing it for NDA 219776.
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BioCaryst added U.S. Patent 10,662,160 to the Orange Book listing for Orladeyo (berotralstat dihydrochloride), NDA 219776, extending patent protection on the drug.
New: New record
BioKryst added U.S. Patent 11,117,867 to the Orange Book for Orladeyo (berotralstat dihydrochloride), extending patent protection for the NDA 219776 formulation.
New: New record
Biocryst added U.S. Patent 10,689,346 to the Orange Book for Orladeyo (berotralstat dihydrochloride) NDA 219776.
New: New record
BioCryst added U.S. Patent 11,230,530 to the Orange Book for Orladeyo (berotralstat dihydrochloride), establishing patent protection for NDA 219776.
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BioKryst added U.S. Patent No. 10,125,102 to the Orange Book for Orladeyo (berotralstat dihydrochloride) NDA 219776.
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BioCryst added U.S. Patent 11,230,530 to the Orange Book for Orladeyo (berotralstat dihydrochloride), covering NDA 219776 strength 110 mg.
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BioRyst added U.S. Patent 10,125,102 to the Orange Book for Orladeyo (berotralstat dihydrochloride), extending patent protection for this kallikrein inhibitor.
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BioiCryst added U.S. Patent 10,689,346 to the Orange Book listing for Orladeyo (berotralstat dihydrochloride), NDA 219776, for strength 110 mg.
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BioKryst added U.S. Patent 12,344,585 to the Orange Book for Orladeyo (berotralstat dihydrochloride), extending patent protection for NDA 219776.
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BIOCRYST listed U.S. Patent 11,618,733 for ORLADEYO (berotralstat dihydrochloride) in the Orange Book.
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BioControl Systems, Inc. patent 11,618,733 covering berotralstat dihydrochloride (Orladeyo) was listed in the Orange Book for NDA 219776.
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BioRyst added U.S. Patent 11,117,867 to the Orange Book for ORLADEYO (berotralstat dihydrochloride), NDA 219776.
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BioCryst added U.S. Patent 11,230,530 to the Orange Book for Orladeyo (berotralstat dihydrochloride), extending patent protection for NDA 219776.
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BioMed Pharma added U.S. Patent 12,344,585 to the Orange Book for Orladeyo (berotralstat dihydrochloride), extending patent protection until at least the patent's expiration date.
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