Remove trial restrictions ▶ Start for $1

Serving leading biopharmaceutical companies globally:

Dow
Mallinckrodt
Boehringer Ingelheim
Colorcon
Medtronic
Express Scripts

Last Updated: October 6, 2022

CALCIUM OXYBATE; MAGNESIUM OXYBATE; POTASSIUM OXYBATE; SODIUM OXYBATE - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard

▶ Start for $1
Remove trial restrictions


What are the generic sources for calcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate and what is the scope of freedom to operate?

Calcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate is the generic ingredient in one branded drug marketed by Jazz and is included in one NDA. There are twelve patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Calcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate has sixty-eight patent family members in twenty-five countries.

One supplier is listed for this compound.

Summary for CALCIUM OXYBATE; MAGNESIUM OXYBATE; POTASSIUM OXYBATE; SODIUM OXYBATE
Pharmacology for CALCIUM OXYBATE; MAGNESIUM OXYBATE; POTASSIUM OXYBATE; SODIUM OXYBATE
Paragraph IV (Patent) Challenges for CALCIUM OXYBATE; MAGNESIUM OXYBATE; POTASSIUM OXYBATE; SODIUM OXYBATE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
XYWAV Oral Solution calcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate 0.234 g/0.096 g/ 013 g/0.04 g per mL 212690 1 2021-04-12

US Patents and Regulatory Information for CALCIUM OXYBATE; MAGNESIUM OXYBATE; POTASSIUM OXYBATE; SODIUM OXYBATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Jazz XYWAV calcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate SOLUTION;ORAL 212690-001 Jul 21, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Jazz XYWAV calcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate SOLUTION;ORAL 212690-001 Jul 21, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Jazz XYWAV calcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate SOLUTION;ORAL 212690-001 Jul 21, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Jazz XYWAV calcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate SOLUTION;ORAL 212690-001 Jul 21, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Jazz XYWAV calcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate SOLUTION;ORAL 212690-001 Jul 21, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing 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

International Patents for CALCIUM OXYBATE; MAGNESIUM OXYBATE; POTASSIUM OXYBATE; SODIUM OXYBATE

Country Patent Number Title Estimated Expiration
European Patent Office 3335708 ADMINISTRATION D'ACIDE 4-HYDROXYBUTANOÏQUE ET DE TRANSPORTEURS MONOCARBOXYLATE (ADMINISTRATION OF GAMMA HYDROXYBUTYRATE WITH MONOCARBOXYLATE TRANSPORTERS) See Plans and Pricing
Singapore 11201504637T GAMMA-HYDROXYBUTYRATE COMPOSITIONS AND THEIR USE FOR THE TREATMENT OF DISORDERS See Plans and Pricing
Spain 2827005 See Plans and Pricing
Spain 2660056 See Plans and Pricing
Hong Kong 1215181 γ-羥基丁酸鹽組合物及其治療疾病的用途 (GAMMA HYDROXYBUTYRATE COMPOSITIONS AND THEIR USE FOR THE TREATMENT OF DISORDERS) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for CALCIUM OXYBATE; MAGNESIUM OXYBATE; POTASSIUM OXYBATE; SODIUM OXYBATE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2957286 122018000145 Germany See Plans and Pricing PRODUCT NAME: PATIROMER SORBITEX CALCIUM IN ALLEN VOM GRUNDPATENT GESCHUETZTEN FORMEN; REGISTRATION NO/DATE: EU/1/17/1179 20170719
2957286 LUC00094 Luxembourg See Plans and Pricing PRODUCT NAME: PATIROMER SORBITEX CALCIUM; AUTHORISATION NUMBER AND DATE: EU/1/17/1179 20170721
2957286 2018C/047 Belgium See Plans and Pricing PRODUCT NAME: PATIROMER SORBITEX CALCIUM; AUTHORISATION NUMBER AND DATE: EU/1/17/1179 20170721
2957286 2018/046 Ireland See Plans and Pricing PRODUCT NAME: PATIROMER SORBITEX CALCIUM; REGISTRATION NO/DATE: EU/1/17/1179 20170719
0933372 13/2008 Austria See Plans and Pricing PRODUCT NAME: FOSAMPRENAVIR ALS FOSAMPRENAVIR-CALCIUM; REGISTRATION NO/DATE: EU/1/04/282/001 - EU/1/04/282/002 (MITTEILUNG VOM 14.07.2004) 20040713
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Express Scripts
Boehringer Ingelheim
Medtronic
Colorcon
Harvard Business School
Mallinckrodt

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.