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NEXTERONE Drug Profile
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When 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-three 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.
Summary for NEXTERONE
| International Patents: | 51 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 95 |
| Clinical Trials: | 3 |
| Patent Applications: | 728 |
| Formulation / Manufacturing: | see details |
| What excipients (inactive ingredients) are in NEXTERONE? | NEXTERONE excipients list |
| 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 |
|---|---|---|
| World Intellectual Property Organization (WIPO) | 2009134347 | Start Trial |
| Japan | 2015110671 | Start Trial |
| Japan | 5656692 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
