lumryz Drug Patent Profile
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When do Lumryz patents expire, and what generic alternatives are available?
Lumryz is a drug marketed by Avadel Cns and is included in one NDA. There are eighteen patents protecting this drug.
This drug has twenty-six patent family members in ten countries.
The generic ingredient in LUMRYZ is sodium oxybate. There are one thousand four hundred and seventy-two drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the sodium oxybate profile page.
DrugPatentWatch® Generic Entry Outlook for Lumryz
There are two tentative approvals for the generic drug (sodium oxybate), which indicates the potential for near-term generic launch.
Indicators of Generic Entry
Summary for lumryz
| International Patents: | 26 |
| US Patents: | 18 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 37 |
| Patent Applications: | 75 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for lumryz |
| What excipients (inactive ingredients) are in lumryz? | lumryz excipients list |
| DailyMed Link: | lumryz at DailyMed |
Pharmacology for lumryz
| Drug Class | Central Nervous System Depressant |
| Physiological Effect | Central Nervous System Depression Decreased Central Nervous System Organized Electrical Activity |
Anatomical Therapeutic Chemical (ATC) Classes for lumryz
US Patents and Regulatory Information for lumryz
lumryz is protected by eighteen US patents and two FDA Regulatory Exclusivities.
Patents protecting lumryz
Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
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Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
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Gamma-hydroxybutyrate compositions having improved pharmacokinetics in the fed state
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Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
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Patented Use: TREATMENT OF A DISORDER TREATABLE WITH GAMMA-HYDROXYBUTYRATE USING A SINGLE, DAILY DOSE OF A GAMMA-HYDROXYBUTYRATE FORMULATION
Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
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Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
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Patented Use: TREATMENT OF NARCOLEPSY USING A DOSE PROPORTIONAL, ORAL PHARMACEUTICAL COMPOSITION COMPRISING GAMMA-HYDROXYBUTYRATE ONCE DAILY
Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
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Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
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Patented Use: TREATMENT OF NARCOLEPSY AND ASSOCIATED DISORDERS AND SYMPTOMS USING A COMPOSITION COMPRISING GAMMA-HYDROXYBUTYRATE ONCE DAILY
Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
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Patented Use: TREATMENT OF NARCOLEPSY, CATAPLEXY OR EXCESSIVE DAYTIME SLEEPINESS USING A ONCE-NIGHTLY GAMMA-HYDROXYBUTYRATE FORMULATION
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Patented Use: TREATMENT OF NARCOLEPSY-RELATED CATAPLEXY OR EXCESSIVE DAYTIME SLEEPINESS USING A SINGLE DAILY, BEDTIME DOSE OF A GAMMA-HYDROXYBUTYRATE FORMULATION
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Patented Use: TREATMENT OF NARCOLEPSY-RELATED CATAPLEXY OR EXCESSIVE DAYTIME SLEEPINESS USING A ONCE-DAILY PHARMACEUTICAL FORMULATION COMPRISING AN OXYBATE
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Patented Use: TREATMENT OF CATAPLEXY OR EXCESSIVE DAYTIME SLEEPINESS IN PATIENTS WITH NARCOLEPSY WHO HAVE AN APNEA/HYPOPNEA INDEX ≤15 WITH A ONCE-NIGHTLY FORMULATION OF GAMMA-HYDROXYBUTYRATE
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Patented Use: TREATMENT OF CATAPLEXY OR EXCESSIVE DAYTIME SLEEPINESS IN PATIENTS WITH NARCOLEPSY WITH A ONCE-NIGHTLY GAMMA-HYDROXYBUTYRATE FORMULATION
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FDA Regulatory Exclusivity protecting lumryz
TREATMENT OF CATAPLEXY OR EXCESSIVE DAYTIME SLEEPINESS (EDS) IN ADULTS WITH NARCOLEPSY
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NEW PRODUCT
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Avadel Cns | LUMRYZ | sodium oxybate | FOR SUSPENSION, EXTENDED RELEASE;ORAL | 214755-004 | May 1, 2023 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Avadel Cns | LUMRYZ | sodium oxybate | FOR SUSPENSION, EXTENDED RELEASE;ORAL | 214755-003 | May 1, 2023 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Avadel Cns | LUMRYZ | sodium oxybate | FOR SUSPENSION, EXTENDED RELEASE;ORAL | 214755-002 | May 1, 2023 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Avadel Cns | LUMRYZ | sodium oxybate | FOR SUSPENSION, EXTENDED RELEASE;ORAL | 214755-003 | May 1, 2023 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
EU/EMA Drug Approvals for lumryz
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| UCB Pharma Ltd | Xyrem | sodium oxybate | EMEA/H/C/000593 Treatment of narcolepsy with cataplexy in adult patients. |
Authorised | no | no | no | 2005-10-13 | |
| D&A Pharma | Hopveus | sodium oxybate | EMEA/H/C/004962 Substitution treatment for alcohol dependence within a framework of careful medical supervision along with continuous psychosocial support and social rehabilitation. Treatment should be initiated only in patients resistant to existing interventions or in patients for whom existing therapies are contra-indicated or not recommended. |
Refused | no | no | no | 2020-07-06 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for lumryz
See the table below for patents covering lumryz around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Japan | 2022120196 | 薬物動態が改善された放出調節ガンマ－ヒドロキシ酪酸塩製剤 | ⤷ Sign Up |
| Canada | 3028878 | FORMULATIONS DE GAMMA-HYDROXYBUTYRATE A LIBERATION MODIFIEE AYANT UNE PHARMACOCINETIQUE AMELIOREE (MODIFIED RELEASE GAMMA-HYDROXYBUTYRATE FORMULATIONS HAVING IMPROVED PHARMACOKINETICS) | ⤷ Sign Up |
| World Intellectual Property Organization (WIPO) | 2020178695 | ⤷ Sign Up | |
| Argentina | 109376 | FORMULACIONES DE g-HIDROXIBUTIRATO DE LIBERACIÓN MODIFICADA | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for lumryz
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1856135 | SPC/GB20/016 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: FOSTAMATINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT OF FOSTAMATINIB, OR A HYDRATE, SOLVATE OR N-OXIDE OF FOSTAMATINIB OR THE PHARMACEUTICALLY ACCEPTABLE SALT OF FOSTAMATINIB, ESPECIALLY FOSTAMATINIB DISODIUM, OPTIONALLY IN FORM OF A HYDRATE; REGISTERED: UK EU/1/19/1405 (NI) 20200113; UK PLGB 12930/0022 20200113; UK PLGB 12930/0023 20200113 |
| 1499331 | SPC/GB13/034 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: IZINOVA CONCENTRATE FOR ORAL SOLUTION. THE ACTIVE SUBSTANCE IS A MIXTURE OF 3 SALTS:SODIUM SULPHATE ANHYDROUS, MAGNESIUM SULPHATE HEPTAHYDRATE AND POTASSIUM SULPHATE.; REGISTERED: BE BE434323 20130220; UK PL34926/0016 20130313 |
| 3141251 | 301099 | Netherlands | ⤷ Sign Up | PRODUCT NAME: A MEDICINAL PRODUCT CONSISTING OF A COMBINATION OF A FIRST DOSE PHARMACEUTICAL COMPOSITION AND A SECOND DOSE PHARMACEUTICAL COMPOSITION, THE FIRST DOSE PHARMACEUTICAL COMPOSITION CONSISTING OF THE ACTIVE INGREDIENTS POLYETHYLENE GLYCOL, SODIUM SULPHATE, SODIUM CHLORIDE AND POTASSIUM CHLORIDE AND THE SECOND DOSE PHARMACEUTICAL COMPOSITION CONSISTING OF THE ACTIVE INGREDIENTS POLYETHYLENE GLYCOL, ASCORBIC ACID, SODIUM ASCORBATE, SODIUM CHLORIDE AND POTASSIUM CHLORIDE; NATIONAL REGISTRATION NO/DATE: RVG 120195 20171114; FIRST REGISTRATION: IS IS/1/17/083/01 20171016 |
| 2563920 | CR 2019 00001 | Denmark | ⤷ Sign Up | PRODUCT NAME: INOTERSEN AND SALT THEREOF, INCLUDING SODIUM SALTS; REG. NO/DATE: EU/1/18/1296 20180710 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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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