LUMRYZ Drug Patent Profile
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Which patents cover Lumryz, 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-nine 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
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Summary for LUMRYZ
International Patents: | 29 |
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 |
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 | |||
Avadel Cns | LUMRYZ | sodium oxybate | FOR SUSPENSION, EXTENDED RELEASE;ORAL | 214755-004 | May 1, 2023 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ 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 |
---|---|---|---|
Australia | 2017300845 | Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics | ⤷ Sign Up |
World Intellectual Property Organization (WIPO) | 2018015563 | ⤷ Sign Up | |
Uruguay | 37341 | FORMULACIONES DE GAMMA-HIDROXIBUTIRATO DE LIBERACIÓN MODIFICADA CON FARMACOCINÉTICA MEJORADA | ⤷ Sign Up |
European Patent Office | 3487483 | FORMULATIONS À LIBÉRATION MODIFIÉE DE GAMMA-HYDROXYBUTYRATE AYANT UNE PHARMACOCINÉTIQUE AMÉLIORÉE (MODIFIED RELEASE GAMMA-HYDROXYBUTYRATE FORMULATIONS HAVING IMPROVED PHARMACOKINETICS) | ⤷ Sign Up |
Brazil | 112021013766 | Composições de gama-hidroxibutirato com farmacocinética melhorada no estado alimentado | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for LUMRYZ
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2822954 | 2018/031 | Ireland | ⤷ Sign Up | PRODUCT NAME: BICTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BICTEGRAVIR SODIUM.; REGISTRATION NO/DATE: EU/1/18/1289 20180625 |
0788511 | SPC/GB08/036 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: MICAFUNGIN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF IN PARTICULAR MICAFUNGIN SODIUM; REGISTERED: UK EU/1/08/448/001 20080425; UK EU/1/08/448/002 20080425 |
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 |
1175904 | 2007C/048 | Belgium | ⤷ Sign Up | PRODUCT NAME: ALENDRONATE DE SODIUM/COLECALCIFEROL; AUTHORISATION NUMBER AND DATE: EU/1/05/310/001 20050826 |
2822954 | SPC/GB18/031 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: BICTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BICTEGRAVIR SODIUM.; REGISTERED: UK EU/1/18/1289/001(NI) 20180625; UK EU/1/18/1289/002(NI) 20180625; UK PLGB 11972/0008 20180625 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |