INTERMEZZO Drug Patent Profile
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When do Intermezzo patents expire, and what generic alternatives are available?
Intermezzo is a drug marketed by Purdue Pharma and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.
This drug has thirty-five patent family members in thirteen countries.
The generic ingredient in INTERMEZZO is zolpidem tartrate. There are thirty-three drug master file entries for this compound. Forty-eight suppliers are listed for this compound. Additional details are available on the zolpidem tartrate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Intermezzo
A generic version of INTERMEZZO was approved as zolpidem tartrate by ACME LABS on April 23rd, 2007.
Summary for INTERMEZZO
International Patents: | 35 |
US Patents: | 4 |
Applicants: | 1 |
NDAs: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 47 |
Clinical Trials: | 1 |
Patent Applications: | 4,100 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for INTERMEZZO |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for INTERMEZZO |
What excipients (inactive ingredients) are in INTERMEZZO? | INTERMEZZO excipients list |
DailyMed Link: | INTERMEZZO at DailyMed |


See drug prices for INTERMEZZO

Recent Clinical Trials for INTERMEZZO
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Transcept Pharmaceuticals | Phase 3 |
Anatomical Therapeutic Chemical (ATC) Classes for INTERMEZZO
Paragraph IV (Patent) Challenges for INTERMEZZO
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
INTERMEZZO | Sublingual Tablets | zolpidem tartrate | 1.75 mg and 3.5 mg | 022328 | 1 | 2012-04-10 |
US Patents and Regulatory Information for INTERMEZZO
INTERMEZZO is protected by four US patents.
Patents protecting INTERMEZZO
Compositions for delivering hypnotic agents across the oral mucosa and methods of use thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD FOR TREATING INSOMNIA
Compositions for delivering hypnotic agents across the oral mucosa and methods of use thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD FOR TREATING INSOMNIA
Methods of treating middle-of-the-night insomnia
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF TREATING MIDDLE-OF-THE-NIGHT INSOMNIA
Compositions for treating insomnia
Patent Number: ⤷ Try a Trial
Patent 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Purdue Pharma | INTERMEZZO | zolpidem tartrate | TABLET;SUBLINGUAL | 022328-001 | Nov 23, 2011 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Purdue Pharma | INTERMEZZO | zolpidem tartrate | TABLET;SUBLINGUAL | 022328-002 | Nov 23, 2011 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Purdue Pharma | INTERMEZZO | zolpidem tartrate | TABLET;SUBLINGUAL | 022328-001 | Nov 23, 2011 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Purdue Pharma | INTERMEZZO | zolpidem tartrate | TABLET;SUBLINGUAL | 022328-002 | Nov 23, 2011 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ 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 |
International Patents for INTERMEZZO
See the table below for patents covering INTERMEZZO around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
China | 100548281 | ⤷ Try a Trial | |
Israel | 177227 | תכשירים המכילים זולפידם לנתינת גורם היפנוטי דרך רירית הפה לטיפול בנדודי שינה (Compositions comprising zolpidem for delivering a hypnotic agent across the oral mucosa for treating insomnia) | ⤷ Try a Trial |
New Zealand | 563979 | Solid compositions and methods for treating middle-of-the night insomnia | ⤷ Try a Trial |
Japan | 2007523091 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for INTERMEZZO
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
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 | 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 |
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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |