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NEXTERONE Drug Profile
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See Plans and PricingWhich patents cover Nexterone, and when can generic versions of Nexterone launch?
Nexterone is a drug marketed by Baxter Hlthcare and is included in one NDA. There are two patents protecting this drug.
This drug has fifty-one patent family members in twenty countries.
The generic ingredient in NEXTERONE is amiodarone hydrochloride. There are fifteen drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the amiodarone hydrochloride profile page.
US ANDA Litigation and Generic Entry Outlook for Nexterone
A generic version of NEXTERONE was approved as amiodarone hydrochloride by TEVA PHARMS on November 30th, 1998.
Summary for NEXTERONE
| International Patents: | 51 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 79 |
| Clinical Trials: | 2 |
| Patent Applications: | 680 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for NEXTERONE |
| DailyMed Link: | NEXTERONE at DailyMed |
Recent Clinical Trials for NEXTERONE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| National Institute on Drug Abuse (NIDA) | Phase 4 |
| Rockefeller University | Phase 4 |
| National Heart, Lung, and Blood Institute (NHLBI) | Phase 3 |
Recent Litigation for NEXTERONE
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| CELGENE CORPORATION v. DR. REDDY'S LABORATORIES, LTD. | 2019-07-12 |
| CELGENE CORPORATION v. SYNTHON PHARMECEUTICALS, INC. | 2018-06-19 |
| MERCK SHARP & DOHME CORP. v. MYLAN LABORATORIES LIMITED | 2018-03-29 |
Pharmacology for NEXTERONE
Synonyms for NEXTERONE
| (2-butyl-1-benzofuran-3-yl)-[4-(2-diethylaminoethyloxy)-3,5-diiodophenyl]methanone hydrochloride |
| (2-butyl-1-benzofuran-3-yl)-[4-[2-(diethylamino)ethoxy]-3,5-diiodophenyl]methanone;hydrochloride |
| (2-Butyl-1-benzofuran-3-yl){4-[2-(diethylamino)ethoxy]-3,5-diiodophenyl}methanone hydrochloride (1:1) |
| (2-butylbenzofuran-3-yl)-[4-[2-(diethylamino)ethoxy]-3,5-diiodo-phenyl]methanone hydrochloride |
| (2-Butylbenzofuran-3-yl)(4-(2-(diethylamino)ethoxy)-3,5-diiodophenyl)methanone hydrochloride |
| {2-[4-(2-butyl-1-benzofuran-3-carbonyl)-2,6-diiodophenoxy]ethyl}diethylamine hydrochloride |
| 19774-82-4 |
| 2-Butyl-3-benzofuranyl 4-(2-(diethylamino)ethoxy)-3,5-diiodophenyl ketone hydrochloride |
| 2-Butyl-3-benzofuranyl 4-[(2-diethylamino)ethoxy] 3,5-diiodophenyl ketone, hydrochloride |
| 2-Butyl-3-benzofuranyl)-[4-[2-(diethylamino)ethoxy]-3,5-diiodo-phenyl]-methanone hydrochloride |
| 2-Butyl-3-benzofuryl 4-(2-(diethylamino)ethoxy)-3,5-diiodophenyl ketone hydrochloride |
| 51087 N HCl |
| 774A824 |
| 976728SY6Z |
| A 8423 |
| AB0012080 |
| AC-078 |
| AC1L9AZ7 |
| ACT02681 |
| AKOS015844018 |
| Amio-Aqueous |
| Amiodar |
| Amiodarone (hydrochloride) |
| Amiodarone HCL |
| Amiodarone hydrochloride |
| Amiodarone hydrochloride (JP17/USAN) |
| Amiodarone hydrochloride [JAN] |
| Amiodarone hydrochloride [USP:JAN] |
| Amiodarone Hydrochloride 1.0 mg/ml in Methanol (as free base) |
| Amiodarone hydrochloride solution, 1.0 mg/mL in methanol (as free base), ampule of 1 mL, certified reference material |
| Amiodaronum hydrochloride |
| AN-6656 |
| Ancaron |
| Ancaron (TN) |
| Angoron |
| API0001454 |
| Atlansil |
| BBC/822 |
| BC207085 |
| BCP13645 |
| BG0032 |
| C25H30ClI2NO3 |
| calcium channel (L type) blocker |
| CAS-19774-82-4 |
| CC-24084 |
| CCG-39607 |
| CHEBI:2664 |
| CHEMBL1083993 |
| Cordarone (TN) |
| CPD000058296 |
| CS-1371 |
| D00636 |
| DSSTox_CID_17185 |
| DSSTox_GSID_37185 |
| DSSTox_RID_79304 |
| DTXSID7037185 |
| EINECS 243-293-2 |
| EU-0100122 |
| FT-0083531 |
| FT-0622300 |
| HMS1569A20 |
| HSDB 6525 |
| HY-14188 |
| Ketone, 2-butyl-3-benzofuranyl 4-(2-(diethylamino)ethoxy)-3,5-diiodophenyl, hydrochloride |
| Ketone,5-diiodophenyl, hydrochloride |
| KS-5249 |
| L 3428 labaz |
| LP00122 |
| Methanone, (2-butyl-3-benzofuranyl)(4-(2-(diethylamino)ethoxy)-3,5-diiodophenyl)-, hydrochloride (9CI) |
| Methanone,5-diiodophenyl]-, hydrochloride |
| MFCD00069204 |
| Miodrone |
| MLS000028520 |
| MLS001076313 |
| MLS001424272 |
| MLS002222247 |
| MolPort-002-915-715 |
| NC00423 |
| NCGC00015096-12 |
| NCGC00093613-01 |
| NCGC00093613-02 |
| NCGC00093613-03 |
| NCGC00093613-04 |
| NCGC00254295-01 |
| NCGC00260807-01 |
| NSC 85442 |
| NSC-759560 |
| NSC-85442 |
| NSC759560 |
| NSC85442 |
| Opera_ID_568 |
| Pacerone |
| Pharmakon1600-02300165 |
| PM-101 |
| Prestwick_707 |
| Q-200626 |
| Renodoron |
| Ritmocardyl |
| Rythmarone |
| s1979 |
| SAM001246646 |
| SCHEMBL41348 |
| SK&F-33134-A |
| SKF 33134 A |
| SKF 33134-A |
| SMR000058296 |
| SPECTRUM2300165 |
| SR-01000003087 |
| SR-01000003087-2 |
| SR-01000003087-8 |
| SW196856-4 |
| TL8001651 |
| Tox21_113478 |
| Tox21_300395 |
| Tox21_500122 |
| Trangorex |
| UNII-976728SY6Z |
| W-5062 |
| WLN: T56 BOJ C4 DVR CI EI DO2N2&2 &GH |
| Z2210825534 |
| ZX-AS005021 |
US Patents and Regulatory Information for NEXTERONE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baxter Hlthcare | NEXTERONE | amiodarone hydrochloride | INJECTABLE;INJECTION | 022325-001 | Dec 24, 2008 | DISCN | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Baxter Hlthcare | NEXTERONE | amiodarone hydrochloride | INJECTABLE;INJECTION | 022325-002 | Nov 16, 2010 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Baxter Hlthcare | NEXTERONE | amiodarone hydrochloride | INJECTABLE;INJECTION | 022325-001 | Dec 24, 2008 | DISCN | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for NEXTERONE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Baxter Hlthcare | NEXTERONE | amiodarone hydrochloride | INJECTABLE;INJECTION | 022325-001 | Dec 24, 2008 | Start Trial | Start Trial |
| Baxter Hlthcare | NEXTERONE | amiodarone hydrochloride | INJECTABLE;INJECTION | 022325-001 | Dec 24, 2008 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for NEXTERONE
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Denmark | 2402008 | Start Trial |
| South Korea | 20040106452 | Start Trial |
| Brazil | PI0905080 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
