NEXTERONE Drug Patent 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-two 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.
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: | 52 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 99 |
| Clinical Trials: | 3 |
| Patent Applications: | 747 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for NEXTERONE |
| What excipients (inactive ingredients) are in NEXTERONE? | NEXTERONE excipients list |
| DailyMed Link: | NEXTERONE at DailyMed |
Recent Clinical Trials for NEXTERONE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Calgary | Phase 4 |
| National Institute on Drug Abuse (NIDA) | Phase 4 |
| Rockefeller University | Phase 4 |
Anatomical Therapeutic Chemical (ATC) Classes for NEXTERONE
US Patents and Regulatory Information for NEXTERONE
NEXTERONE is protected by two US patents.
Patents protecting NEXTERONE
Formulations containing amiodarone and sulfoalkyl ether cyclodextrin
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Sulfoalkyl ether cyclodextrin compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
| 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 | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
| Baxter Hlthcare | NEXTERONE | amiodarone hydrochloride | INJECTABLE;INJECTION | 022325-002 | Nov 16, 2010 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
| Baxter Hlthcare | NEXTERONE | amiodarone hydrochloride | INJECTABLE;INJECTION | 022325-001 | Dec 24, 2008 | DISCN | Yes | No | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
| >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 | 022325-002 | Nov 16, 2010 | See Plans and Pricing | See Plans and Pricing |
| Baxter Hlthcare | NEXTERONE | amiodarone hydrochloride | INJECTABLE;INJECTION | 022325-001 | Dec 24, 2008 | See Plans and Pricing | See Plans and Pricing |
| Baxter Hlthcare | NEXTERONE | amiodarone hydrochloride | INJECTABLE;INJECTION | 022325-001 | Dec 24, 2008 | See Plans and Pricing | See Plans and Pricing |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for NEXTERONE
See the table below for patents covering NEXTERONE around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Germany | 69331900 | See Plans and Pricing | |
| Australia | 672814 | See Plans and Pricing | |
| Japan | H05504783 | See Plans and Pricing | |
| >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. 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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