LUMRYZ Drug Patent Profile
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When do Lumryz patents expire, and when can generic versions of Lumryz launch?
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-five 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: | 25 |
| 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
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Gamma-hydroxybutyrate compositions having improved pharmacokinetics in the fed state
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF NARCOLEPSY, CATAPLEXY OR EXCESSIVE DAYTIME SLEEPINESS USING A ONCE-NIGHTLY GAMMA-HYDROXYBUTYRATE FORMULATION
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF NARCOLEPSY-RELATED CATAPLEXY OR EXCESSIVE DAYTIME SLEEPINESS USING A SINGLE DAILY, BEDTIME DOSE OF A GAMMA-HYDROXYBUTYRATE FORMULATION
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF NARCOLEPSY-RELATED CATAPLEXY OR EXCESSIVE DAYTIME SLEEPINESS USING A ONCE-DAILY PHARMACEUTICAL FORMULATION COMPRISING AN OXYBATE
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF CATAPLEXY OR EXCESSIVE DAYTIME SLEEPINESS IN PATIENTS WITH NARCOLEPSY WITH A ONCE-NIGHTLY GAMMA-HYDROXYBUTYRATE FORMULATION
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
FDA Regulatory Exclusivity protecting LUMRYZ
TREATMENT OF CATAPLEXY OR EXCESSIVE DAYTIME SLEEPINESS (EDS) IN ADULTS WITH NARCOLEPSY
Exclusivity Expiration: ⤷ Try a Trial
NEW PRODUCT
Exclusivity Expiration: ⤷ Try a Trial
| 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 | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Avadel Cns | LUMRYZ | sodium oxybate | FOR SUSPENSION, EXTENDED RELEASE;ORAL | 214755-003 | May 1, 2023 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Avadel Cns | LUMRYZ | sodium oxybate | FOR SUSPENSION, EXTENDED RELEASE;ORAL | 214755-002 | May 1, 2023 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Avadel Cns | LUMRYZ | sodium oxybate | FOR SUSPENSION, EXTENDED RELEASE;ORAL | 214755-003 | May 1, 2023 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Avadel Cns | LUMRYZ | sodium oxybate | FOR SUSPENSION, EXTENDED RELEASE;ORAL | 214755-004 | May 1, 2023 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Avadel Cns | LUMRYZ | sodium oxybate | FOR SUSPENSION, EXTENDED RELEASE;ORAL | 214755-003 | May 1, 2023 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| >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 |
|---|---|---|---|
| Canada | 3210888 | FORMULATIONS A LIBERATION MODIFIEE DE GAMMA-HYDROXYBUTYRATE AYANT UNE PHARMACOCINETIQUE AMELIOREE (MODIFIED RELEASE GAMMA-HYDROXYBUTYRATE FORMULATIONS HAVING IMPROVED PHARMACOKINETICS) | ⤷ Try a Trial |
| Japan | 2020100670 | 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) | ⤷ Try a Trial |
| 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 | ⤷ Try a Trial |
| Japan | 7398999 | ⤷ Try a Trial | |
| Japan | 2022522270 | 食事摂取状態における改善された薬物動態を有するガンマ－ヒドロキシ酪酸塩組成物 | ⤷ Try a Trial |
| China | 113473980 | 在进食状态下具有改善的药代动力学的γ-羟基丁酸酯组合物 (GAMMA-HYDROXYBUTYRATE COMPOSITIONS HAVING IMPROVED PHARMACOKINETICS IN THE FED STATE) | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for LUMRYZ
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2932970 | 1890039-9 | Sweden | ⤷ Try a Trial | PRODUCT NAME: DOLUTEGRAVIR SODIUM + RILPIVIRINE HYDROCHLORIDE; REG. NO/DATE: EU/1/18/1282 20180518 |
| 2465580 | SPC/GB21/030 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: CABOTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, INCLUDING CABOTEGRAVIR SODIUM.; REGISTERED: UK EU/1/20/1481 (NI) 20201221; UK PLGB 35728/0055-57 20201221 |
| 0806968 | SPC/GB07/011 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: GADOFOSVESET TRISODIUM; REGISTERED: UK EU/1/05/313/001 20051003; UK EU/1/05/313/002 20051003; UK EU/1/05/313/003 20051003; UK EU/1/05/313/004 20051003; UK EU/1/05/313/005 20051003; UK EU/1/05/313/006 20051003; UK EU/1/05/313/007 20051003; UK EU/1/05/313/008 20051003; UK EU/1/05/313/009 20051003 |
| 2203431 | 1590018-6 | Sweden | ⤷ Try a Trial | PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REG. NO/DATE: EU/1/14/983 20150119 |
| 0579826 | 02C0041 | France | ⤷ Try a Trial | PRODUCT NAME: ERTAPENEM SODIUM; REGISTRATION NO/DATE: EU/1/02/216/001 20020418 |
| 2380576 | 20C1048 | France | ⤷ Try a Trial | PRODUCT NAME: SEL DE SODIUM DE L'ACIDE DESOXYCHOLIQUE; NAT. REGISTRATION NO/DATE: NL46299 20180810; FIRST REGISTRATION: IS - IS/1/16/071/01 20160729 |
| >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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