BUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE | N215430 | AXSOME THERAPEUTICS INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
AXSOME THERAPEUTICS, INC. et al v. TEVA PHARMACEUTICALS, INC. 4 patentsANDA 218147dextromethorphan hydrobromide and bupropion hydrochloride | D.N.J. | 2023-03-24 | Terminated 2025-02-11 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| 8569328 | Jul 18, 2032 | — | — | Yes | — | |
| 9168234 | Nov 5, 2034 | — | — | — | — | |
| 9198905 | Nov 5, 2034 | — | — | — | — | |
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| 11007189 | Nov 5, 2034 | — | — | — | U-4516 | — |
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| 11191739 | Nov 5, 2034 | — | — | Yes | — | |
| 11197839 | Nov 5, 2034 | — | — | Yes | — | |
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| 11433067 | Nov 5, 2034 | — | — | Yes | — | |
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| 11534414 | Nov 5, 2034 | — | — | Yes | — | |
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| 12109178 | Nov 5, 2034 | — | — | — | — | |
| 12146889 | Feb 23, 2043 | — | — | — | — | |
| 12156914 | Jan 20, 2043 | — | — | Yes | — | — |
| 12194005 | Jan 23, 2043 | — | — | — | U-4523 | — |
| 12194036 | Apr 20, 2043 | — | — | — | U-4521 | — |
| 12239642 | Jan 20, 2043 | — | — | — | U-4515 | — |
| 12263161 | Jan 20, 2043 | — | — | — | U-4515 | — |
| 12310961 | Jan 20, 2043 | — | — | — | — | |
| 12357697 | Jan 20, 2043 | — | — | — | — | |
| 12364674 | Jan 23, 2043 | — | — | — | U-4516 | — |
| 12370154 | Feb 15, 2043 | — | — | — | U-4518 | — |
| 12390428 | Dec 1, 2041 | — | — | — | — | |
| 12433884 | Jun 5, 2040 | — | — | — | U-4514 | — |
| 12472155 | Feb 23, 2043 | — | — | — | U-4519 | — |
| 12472156 | Jun 5, 2040 | — | — | — | U-4516 | — |
| 12472174 | Jan 20, 2043 | — | — | — | U-4515 | — |
| 12478622 | Jan 20, 2043 | — | — | — | U-4515 | — |
| 12564587 | Jan 20, 2043 | — | — | — | U-4515 | — |
| 12576078 | Jun 5, 2040 | — | — | — | U-4516 | — |
| 12599576 | Feb 15, 2043 | — | — | — | U-4518 | — |
| Code | Date | Status |
|---|---|---|
| I-913 | Apr 30, 2029 | Active |
Axsome added patent 12194036 to the Orange Book for Auvelity (bupropion hydrochloride; dextromethorphan hydrobromide) under NDA 215430.
New: New record
Axsome added patent 12194005 to the Orange Book for Auvelity (bupropion hydrochloride; dextromethorphan hydrobromide) covering NDA 215430.
New: New record
Axsome added U.S. Patent 11,291,665 to the Orange Book for Auvelity (bupropion hydrochloride/dextromethorphan hydrobromide), NDA 215430.
New: New record
Axsome added U.S. Patent 9,968,568 to the Orange Book for Auvelity (bupropion hydrochloride/dextromethorphan hydrobromide) NDA 215430.
New: New record
Axsome added U.S. Patent 11,419,867 to the Orange Book for Auvelity (bupropion hydrochloride; dextromethorphan hydrobromide) NDA 215430.
New: New record
Axsome added U.S. Patent 9,486,450 to the Orange Book listing for Auvelity (bupropion hydrochloride; dextromethorphan hydrobromide), NDA 215430.
New: New record
Axsome added U.S. Patent 9,205,083 to the Orange Book listing for Auvelity (bupropion hydrochloride/dextromethorphan hydrobromide) under NDA 215430.
New: New record
Axsome added U.S. Patent 9,421,176 to the Orange Book listing for Auvelity (bupropion hydrochloride/dextromethorphan hydrobromide), NDA 215430.
New: New record
Axsome added patent 11007189 to the Orange Book for Auvelity (bupropion hydrochloride; dextromethorphan hydrobromide) NDA 215430.
New: New record
Axsome added patent 11291638 to the Orange Book listing for Auvelity (bupropion hydrochloride; dextromethorphan hydrobromide) under NDA 215430.
New: New record
Axsome added patent 9,700,553 to the Orange Book for Auvelity (bupropion hydrochloride/dextromethorphan hydrobromide) NDA 215430.
New: New record
Axsome added patent 11207281 to the Orange Book for Auvelity (bupropion hydrochloride/dextromethorphan hydrobromide) NDA 215430.
New: New record
Axsome added U.S. Patent 10,105,361 to the Orange Book for AUVELITY (bupropion hydrochloride; dextromethorphan hydrobromide) NDA 215430.
New: New record
Axsome added U.S. Patent 8,569,328 to the Orange Book for Auvelity (bupropion hydrochloride; dextromethorphan hydrobromide) NDA 215430.
New: New record
Axsome added U.S. Patent 11,273,133 to the Orange Book for Auvelity (bupropion hydrochloride and dextromethorphan hydrobromide) NDA 215430.
New: New record
Axsome added U.S. Patent 9,370,513 to the Orange Book for Auvelity (bupropion hydrochloride and dextromethorphan hydrobromide) NDA 215430.
New: New record
Axsome added U.S. Patent 11,298,352 to the Orange Book for Auvelity (bupropion hydrochloride; dextromethorphan hydrobromide) NDA 215430.
New: New record
Axsome added U.S. Patent 12,472,155 to the Orange Book for Auvelity (bupropion hydrochloride/dextromethorphan hydrobromide), NDA 215430.
New: New record
Axsome added U.S. Patent 11,590,124 to the Orange Book for Auvelity (bupropion hydrochloride/dextromethorphan hydrobromide), providing patent protection for NDA 215430.
New: New record
Axsome added U.S. Patent 9,238,032 to the Orange Book for Auvelity (bupropion hydrochloride; dextromethorphan hydrobromide) NDA 215430.
New: New record
Axsome added patent 12564587 to the Orange Book listing for Auvelity (bupropion hydrochloride; dextromethorphan hydrobromide) under NDA 215430.
New: New record
Axsome updated the patent expiration date for U.S. Patent 10,780,066 listed for Auvelity (bupropion hydrochloride/dextromethorphan hydrobromide) from Nov 9, 2034 to Nov 5, 2034.
Old: Nov 9, 2034
New: Nov 5, 2034
AUVELITY's listed patent 8,569,328 patent expiration date moved earlier from Oct 2033 to Jul 2032.
Old: Oct 29, 2033
New: Jul 18, 2032
New: New record
Axsome's Auvelity (bupropion hydrochloride/dextromethorphan hydrobromide) gained a new regulatory exclusivity designation effective with NDA 215430.
New: New record
Axsome added U.S. patent 12,472,156 to the Orange Book for Auvelity (bupropion hydrochloride/dextromethorphan hydrobromide), NDA 215430.
New: New record
Axsome added U.S. Patent 12,263,161 to the Orange Book for Auvelity (bupropion hydrochloride; dextromethorphan hydrobromide) NDA 215430.
New: New record
Axsome added U.S. Patent 11,617,747 to the Orange Book for Auvelity (bupropion hydrochloride; dextromethorphan hydrobromide) NDA 215430.
New: New record
Axsome added U.S. Patent 12,472,156 to the Orange Book for Auvelity (bupropion hydrochloride/dextromethorphan hydrobromide) NDA 215430.
New: New record
Axsome added patent 12599576 to the Orange Book listing for Auvelity (bupropion hydrochloride; dextromethorphan hydrobromide) under NDA 215430.
New: New record
Axsome added U.S. Patent 9,867,819 to the Orange Book listing for Auvelity (bupropion hydrochloride; dextromethorphan hydrobromide) under NDA 215430.
New: New record
Axsome added U.S. Patent 11273134 to the Orange Book for Auvelity (bupropion hydrochloride/dextromethorphan hydrobromide), NDA 215430.
New: New record
Axsome added U.S. Patent 12,364,674 to the Orange Book listing for Auvelity (bupropion hydrochloride/dextromethorphan hydrobromide) under NDA 215430.
New: New record
Axsome added U.S. Patent 11,344,544 to the Orange Book for Auvelity (bupropion hydrochloride/dextromethorphan hydrobromide), NDA 215430.
New: New record
Axsome added U.S. Patent 9,168,234 to the Orange Book for Auvelity (bupropion hydrochloride/dextromethorphan hydrobromide) NDA 215430.
New: New record
Axsome added U.S. Patent 9,457,025 to the Orange Book for Auvelity (bupropion hydrochloride/dextromethorphan hydrobromide), NDA 215430.
New: New record
Axsome added patent 12239642 to the Orange Book listing for Auvelity (bupropion hydrochloride/dextromethorphan hydrobromide) for NDA 215430.
New: New record
Axsome added U.S. Patent 9,474,731 to the Orange Book for Auvelity (bupropion hydrochloride/dextromethorphan hydrobromide), NDA 215430.
New: New record
Axsome added U.S. Patent 11,234,946 to the Orange Book for Auvelity (bupropion hydrochloride/dextromethorphan hydrobromide), NDA 215430.
New: New record
Axsome added US Patent 10,251,879 to the Orange Book for Auvelity (bupropion hydrochloride/dextromethorphan hydrobromide) NDA 215430.
New: New record
Axsome added U.S. Patent 11,426,370 to the Orange Book for Auvelity (bupropion hydrochloride/dextromethorphan hydrobromide), NDA 215430.
New: New record
Axsome added U.S. Patent 11,253,492 to the Orange Book listing for Auvelity (bupropion hydrochloride; dextromethorphan hydrobromide) under NDA 215430.
New: New record
Axsome added patent '10080727' to the Orange Book listing for Auvelity (bupropion hydrochloride; dextromethorphan hydrobromide) under NDA 215430.
New: New record
Axsome added U.S. Patent 11,382,874 to the Orange Book for Auvelity (bupropion hydrochloride; dextromethorphan hydrobromide) NDA 215430.
New: New record
Axsome added US Patent 11,285,146 to the Orange Book for Auvelity (bupropion hydrochloride/dextromethorphan hydrobromide) NDA 215430.
New: New record
Axsome added US Patent 9,375,429 to the Orange Book for Auvelity (bupropion hydrochloride/dextromethorphan hydrobromide) NDA 215430.
New: New record
Axsome added U.S. Patent 11,007,189 to the Orange Book for Auvelity (bupropion hydrochloride/dextromethorphan hydrobromide), NDA 215430.
New: New record
Axsome added U.S. Patent 10,058,518 to the Orange Book for Auvelity (bupropion hydrochloride/dextromethorphan hydrobromide) NDA 215430.
New: New record
Axsome added US Patent 12,370,154 to the Orange Book for Auvelity (bupropion hydrochloride; dextromethorphan hydrobromide), covering NDA 215430.
New: New record
AXSOME added U.S. patent 10,092,560 to the Orange Book listing for AUVELITY (bupropion hydrochloride and dextromethorphan hydrobromide).
New: New record