LUMRYZ Drug Patent Profile
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Which patents cover Lumryz, and when can generic versions of Lumryz launch?
Lumryz is a drug marketed by Avadel Cns and is included in one NDA. There are nineteen patents protecting this drug.
This drug has thirty 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: | 30 |
| US Patents: | 19 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 37 |
| Patent Applications: | 75 |
| 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 nineteen 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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Patented Use: TREATMENT OF NARCOLEPSY-RELATED CATAPLEXY OR EDS IN A HUMAN PATIENT WITH A ONCE-NIGHTLY GHB FORMULATION BY INITIATING TREATMENT WITH A DOSE EQUIVALENT TO 4.5 G OF SODIUM OXYBATE AND UPTITRATING IN INCREMENTS EQUIVALENT TO 1.5 G OF SODIUM OXYBATE
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 | 214755-002 | 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 | ⤷ 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 | ||||
| >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 | 6683886 | ⤷ Sign Up | |
| Japan | 2024069490 | 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 (MODIFIED RELEASE GAMMA-HYDROXYBUTYRATE FORMULATIONS HAVING IMPROVED PHARMACOKINETICS) | ⤷ Sign Up |
| Japan | 2024069489 | 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 (MODIFIED RELEASE GAMMA-HYDROXYBUTYRATE FORMULATIONS HAVING IMPROVED PHARMACOKINETICS) | ⤷ Sign Up |
| China | 114515273 | 具有经改善药代动力学的γ-羟基丁酸盐改进释放制剂 (Improved release formulations of gamma-hydroxybutyrate with improved pharmacokinetics) | ⤷ 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 |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for LUMRYZ
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1912999 | 1490062-5 | Sweden | ⤷ Sign Up | PRODUCT NAME: SIMEPREVIR, OR A SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REG. NO/DATE: EU/1/14/924 20140516 |
| 1856135 | CA 2020 00018 | Denmark | ⤷ 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; REG. NO/DATE: EU/1/19/1405 20200113 |
| 2822954 | LUC00083 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: BICTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BICTEGRAVIR SODIUM; AUTHORISATION NUMBER AND DATE: EU/1/18/1289 20180625 |
| 1856135 | LUC00153 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: FOSTAMATINIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE FOSTAMATINIB, OU UN HYDRATE, SOLVATE OU N-OXYDE DE FOSTAMATINIB OU LE SEL PHARMACEUTIQUEMENT ACCEPTABLE DE FOSTAMATINIB, EN PARTICULIER FOSTAMATINIB DISODIUM, EVENTUELLEMENT SOUS FORME D'HYDRATE; AUTHORISATION NUMBER AND DATE: EU/1/19/1405 20200113 |
| 1948158 | 1690020-1 | Sweden | ⤷ Sign Up | PRODUCT NAME: SACUBITRIL AND VALSARTAN, AS SACUBITRIL VALSARTAN SODIUM SALT COMPLEX, I.E. TRISODIUM 3-((1S,3R)-1-BIPHENYL-4-YLMETHYL-3- ETHOXYCARBONYL-1-BUTYLCARBAMOYL)PROPIONATE-(S)-3-METHYL-2- (PENTANOYL2-(TETRAZOL-5-YLATE)BIPHENYL-4- YLMETHYLAMINO)BUTYRATE HEMIPENTAHYDRATE; REG. NO/DATE: EU/1/15/1058 20151123 |
| >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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