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NEXTERONE Drug Profile
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» See Plans and PricingWhen do Nexterone patents expire, 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 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: | 81 |
| Clinical Trials: | 2 |
| Patent Applications: | 680 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | NEXTERONE at DailyMed |
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 |
|---|---|---|
| Australia | 646020 | Start Trial |
| Canada | 2074186 | Start Trial |
| South Korea | 20040106452 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
