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INTERMEZZO Drug Profile
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See Plans and PricingWhich patents cover Intermezzo, 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-seven 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-six suppliers are listed for this compound. Additional details are available on the zolpidem tartrate profile page.
US ANDA 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: | 37 |
| US Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 33 |
| Clinical Trials: | 1 |
| Patent Applications: | 694 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for INTERMEZZO |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for INTERMEZZO |
| 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 |
Recent Litigation for INTERMEZZO
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Purdue Pharmaceutical v. Actavis Elizabeth LLC | 2015-05-13 |
| SUCAMPO AG v. DR. REDDY'S LABORATORIES, INC. | 2014-11-12 |
| PURDUE PHARMACEUTICAL PRODUCTS L.P. v. TWI PHARMACEUTICALS, INC. | 2013-08-20 |
Pharmacology for INTERMEZZO
| Drug Class | gamma-Aminobutyric Acid-ergic Agonist |
| Mechanism of Action | GABA A Agonists |
| Physiological Effect | Central Nervous System Depression |
Paragraph IV (Patent) Challenges for INTERMEZZO
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| INTERMEZZO | TABLET;SUBLINGUAL | zolpidem tartrate | 022328 | 2012-04-10 |
US Patents and Regulatory Information for INTERMEZZO
| 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 | Start Trial | Start Trial | Y | Start Trial | |||
| Purdue Pharma | INTERMEZZO | zolpidem tartrate | TABLET;SUBLINGUAL | 022328-002 | Nov 23, 2011 | DISCN | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Purdue Pharma | INTERMEZZO | zolpidem tartrate | TABLET;SUBLINGUAL | 022328-001 | Nov 23, 2011 | DISCN | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Purdue Pharma | INTERMEZZO | zolpidem tartrate | TABLET;SUBLINGUAL | 022328-002 | Nov 23, 2011 | DISCN | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Purdue Pharma | INTERMEZZO | zolpidem tartrate | TABLET;SUBLINGUAL | 022328-001 | Nov 23, 2011 | DISCN | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Purdue Pharma | INTERMEZZO | zolpidem tartrate | TABLET;SUBLINGUAL | 022328-001 | Nov 23, 2011 | DISCN | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Purdue Pharma | INTERMEZZO | zolpidem tartrate | TABLET;SUBLINGUAL | 022328-002 | Nov 23, 2011 | DISCN | Yes | No | Start Trial | Start Trial | Start 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
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| European Patent Office | 1883408 | Start Trial |
| Australia | 2006249761 | Start Trial |
| Israel | 187309 | Start Trial |
| Mexico | PA06009296 | Start Trial |
| South Korea | 20080031208 | Start Trial |
| Israel | 229039 | Start Trial |
| Brazil | PI0609984 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for INTERMEZZO
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2236132 | 300714 | Netherlands | Start 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 | 92636 | Luxembourg | Start Trial | PRODUCT NAME: ZOLPIDEM ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES |
| 2236132 | C300714 | Netherlands | Start Trial | PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NAT. REGISTRATION NO/DATE: RVG 108438 - 439 20130624; FIRST REGISTRATION: BE424286BE424295 2012180718 |
| 2236132 | 122015000006 | Germany | Start 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 | CA 2015 00004 | Denmark | Start 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
