INTERMEZZO Drug Patent Profile

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-five 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 23^rd, 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:	515
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

See drug sales revenues for INTERMEZZO

Recent Clinical Trials for INTERMEZZO

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Transcept Pharmaceuticals	Phase 3

See all INTERMEZZO clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for INTERMEZZO

N05CF	Benzodiazepine related drugs
N05C	HYPNOTICS AND SEDATIVES
N05	PSYCHOLEPTICS
N	Nervous system

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

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			Y
Purdue Pharma	INTERMEZZO	zolpidem tartrate	TABLET;SUBLINGUAL	022328-002	Nov 23, 2011		DISCN	Yes	No
Purdue Pharma	INTERMEZZO	zolpidem tartrate	TABLET;SUBLINGUAL	022328-001	Nov 23, 2011		DISCN	Yes	No			Y
Purdue Pharma	INTERMEZZO	zolpidem tartrate	TABLET;SUBLINGUAL	022328-002	Nov 23, 2011		DISCN	Yes	No			Y
Purdue Pharma	INTERMEZZO	zolpidem tartrate	TABLET;SUBLINGUAL	022328-001	Nov 23, 2011		DISCN	Yes	No

International Patents for INTERMEZZO

See the table below for patents covering INTERMEZZO around the world.

Country	Patent Number	Title	Estimated Expiration
Mexico	2007014679	COMPOSICIONES SOLIDAS Y METODOS PARA TRATAR INSOMNIO DE MEDIANOCHE. (SOLID COMPOSITIONS AND METHODS FOR TREATING MIDDLE-OF-THE NIGHT INSOMNIA.)
South Korea	20130006523	COMPOSITIONS FOR DELIVERING HYPNOTIC AGENTS ACROSS THE ORAL MUCOSA AND METHODS OF USE THEREOF
Australia	2006249761	Solid compositions and methods for treating middle-of-the night insomnia
South Korea	20140104986	COMPOSITIONS FOR DELIVERING HYPNOTIC AGENTS ACROSS THE ORAL MUCOSA AND METHODS OF USE THEREOF
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)

Supplementary Protection Certificates for INTERMEZZO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2236132	CA 2015 00004	Denmark		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		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	300714	Netherlands		PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NATIONAL REGISTRATION NO/DATE: RVG 108438 - 439 20160624; REGISTRATION NO/DATE: BE424286 20120718 BE424295 20120718
2236132	C300714	Netherlands		PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NAT. REGISTRATION NO/DATE: RVG 108438 - 439 20130624; FIRST REGISTRATION: BE424286BE424295 2012180718
2236132	92636	Luxembourg		PRODUCT NAME: ZOLPIDEM ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES