EDLUAR Drug Patent Profile
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Which patents cover Edluar, and when can generic versions of Edluar launch?
Edluar is a drug marketed by Mylan Speciality Lp and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.
This drug has twenty patent family members in twelve countries.
The generic ingredient in EDLUAR is zolpidem tartrate. There are thirty-three drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the zolpidem tartrate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Edluar
A generic version of EDLUAR was approved as zolpidem tartrate by ACME LABS on April 23rd, 2007.
Summary for EDLUAR
International Patents: | 20 |
US Patents: | 2 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 18 |
Patent Applications: | 634 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for EDLUAR |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for EDLUAR |
What excipients (inactive ingredients) are in EDLUAR? | EDLUAR excipients list |
DailyMed Link: | EDLUAR at DailyMed |
Pharmacology for EDLUAR
Drug Class | gamma-Aminobutyric Acid-ergic Agonist |
Mechanism of Action | GABA A Agonists |
Physiological Effect | Central Nervous System Depression |
Anatomical Therapeutic Chemical (ATC) Classes for EDLUAR
Paragraph IV (Patent) Challenges for EDLUAR
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
EDLUAR | Sublingual Tablets | zolpidem tartrate | 5 mg and 10 mg | 021997 | 1 | 2010-04-29 |
US Patents and Regulatory Information for EDLUAR
EDLUAR is protected by two US patents.
Patents protecting EDLUAR
Pharmaceutical formulations useful in the treatment of insomnia
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF TREATING INSOMNIA CHARACTERIZED BY DIFFICULTY WITH SLEEP ONSET
Pharmaceutical formulations useful in the treatment of insomnia
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF TREATING INSOMNIA CHARACTERIZED BY DIFFICULTY WITH SLEEP ONSET
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mylan Speciality Lp | EDLUAR | zolpidem tartrate | TABLET;SUBLINGUAL | 021997-001 | Mar 13, 2009 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Mylan Speciality Lp | EDLUAR | zolpidem tartrate | TABLET;SUBLINGUAL | 021997-002 | Mar 13, 2009 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Mylan Speciality Lp | EDLUAR | zolpidem tartrate | TABLET;SUBLINGUAL | 021997-001 | Mar 13, 2009 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Mylan Speciality Lp | EDLUAR | zolpidem tartrate | TABLET;SUBLINGUAL | 021997-002 | Mar 13, 2009 | AB | RX | Yes | Yes | ⤷ 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 |
Expired US Patents for EDLUAR
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Mylan Speciality Lp | EDLUAR | zolpidem tartrate | TABLET;SUBLINGUAL | 021997-001 | Mar 13, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
Mylan Speciality Lp | EDLUAR | zolpidem tartrate | TABLET;SUBLINGUAL | 021997-002 | Mar 13, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
Mylan Speciality Lp | EDLUAR | zolpidem tartrate | TABLET;SUBLINGUAL | 021997-002 | Mar 13, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
Mylan Speciality Lp | EDLUAR | zolpidem tartrate | TABLET;SUBLINGUAL | 021997-001 | Mar 13, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for EDLUAR
See the table below for patents covering EDLUAR around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Australia | 764346 | ⤷ Try a Trial | |
Bulgaria | 65502 | ⤷ Try a Trial | |
Spain | 2644770 | ⤷ Try a Trial | |
Cyprus | 1107711 | ⤷ Try a Trial | |
Slovakia | 4022001 | PHARMACEUTICAL COMPOSITION FOR THE TREATMENT OF ACUTE DISORDERS | ⤷ Try a Trial |
Spain | 2498095 | ⤷ Try a Trial | |
Denmark | 2805716 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for EDLUAR
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2236132 | 92636 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: ZOLPIDEM ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES |
2236132 | 484 | Finland | ⤷ Try a Trial | |
2236132 | CA 2015 00004 | Denmark | ⤷ Try a Trial | PRODUCT NAME: ZOLPIDEM OG FARMACEUTISK ACCEPTABLE SALTE HERAF, HERUNDER ZOLPIDEMTARTRAT; NAT. REG. NO/DATE: 47607 OG 47608 20120719; FIRST REG. NO/DATE: (B BE424286 OG BE424295 20120718 |
2236132 | 122015000006 | Germany | ⤷ Try a Trial | PRODUCT NAME: ZOLPIDEM UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; NAT. REGISTRATION NO/DATE: 83439.00.00 83440.00.00 20120725 FIRST REGISTRATION: BELGIEN BE424286 BE424295 20120718 |
2236132 | C300714 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NAT. REGISTRATION NO/DATE: RVG 108438 - 439 20130624; FIRST REGISTRATION: BE424286BE424295 2012180718 |
2236132 | 300714 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NATIONAL REGISTRATION NO/DATE: RVG 108438 - 439 20160624; REGISTRATION NO/DATE: BE424286 20120718 BE424295 20120718 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |