NEXTERONE Drug Patent Profile
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When do Nexterone patents expire, and what generic alternatives are available?
Nexterone is a drug marketed by Baxter Hlthcare and is included in one NDA. There are six patents protecting this drug and one Paragraph IV challenge.
This drug has seventy-six patent family members in fourteen 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.
DrugPatentWatch® Litigation and Generic Entry Outlook for Nexterone
A generic version of NEXTERONE was approved as amiodarone hydrochloride by TEVA PHARMS on November 30th, 1998.
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Questions you can ask:
- What is the 5 year forecast for NEXTERONE?
- What are the global sales for NEXTERONE?
- What is Average Wholesale Price for NEXTERONE?
Summary for NEXTERONE
| International Patents: | 76 |
| US Patents: | 6 |
| Applicants: | 1 |
| NDAs: | 1 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for NEXTERONE |
Paragraph IV (Patent) Challenges for NEXTERONE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| NEXTERONE | Injection | amiodarone hydrochloride | 150 mg/100 mL | 022325 | 1 | 2025-06-24 |
US Patents and Regulatory Information for NEXTERONE
NEXTERONE is protected by six US patents.
| 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 | 7,635,773 | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| Baxter Hlthcare | NEXTERONE | amiodarone hydrochloride | INJECTABLE;INJECTION | 022325-002 | Nov 16, 2010 | RX | Yes | Yes | 9,750,822 | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| Baxter Hlthcare | NEXTERONE | amiodarone hydrochloride | INJECTABLE;INJECTION | 022325-002 | Nov 16, 2010 | RX | Yes | Yes | 10,177,951 | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| Baxter Hlthcare | NEXTERONE | amiodarone hydrochloride | INJECTABLE;INJECTION | 022325-003 | Nov 16, 2010 | RX | Yes | Yes | 9,750,822 | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| Baxter Hlthcare | NEXTERONE | amiodarone hydrochloride | INJECTABLE;INJECTION | 022325-003 | Nov 16, 2010 | RX | Yes | Yes | 9,200,088 | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| Baxter Hlthcare | NEXTERONE | amiodarone hydrochloride | INJECTABLE;INJECTION | 022325-002 | Nov 16, 2010 | RX | Yes | Yes | 8,410,077 | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| Baxter Hlthcare | NEXTERONE | amiodarone hydrochloride | INJECTABLE;INJECTION | 022325-002 | Nov 16, 2010 | RX | Yes | Yes | 9,493,582 | ⤷ 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 |
International Patents for NEXTERONE
See the table below for patents covering NEXTERONE around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Japan | 2017019879 | ⤷ Start Trial | |
| South Korea | 20160144896 | 예약 톤 설계 방법 및 톤 예약 방식을 이용하여 PAPR 저감을 수행하는 송신기 (PAPR Method for determining reserved tones and transmitter for performing PAPR reduction using tone reservation) | ⤷ Start Trial |
| Japan | 6276828 | ⤷ Start Trial | |
| Mexico | 375873 | ⤷ Start Trial | |
| Japan | 2012072160 | SULFOALKYL ETHER CYCLODEXTRIN COMPOSITION | ⤷ Start Trial |
| Australia | 7236491 | ⤷ Start Trial | |
| Japan | 2018052991 | スルホアルキルエーテルシクロデキストリン組成物 (SULFOALKYL ETHER CYCLODEXTRIN COMPOSITIONS) | ⤷ Start Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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