CLINOLIPID 20% Drug Patent Profile

When do Clinolipid 20% patents expire, and when can generic versions of Clinolipid 20% launch?

Clinolipid 20% is a drug marketed by Baxter Hlthcare Corp and is included in one NDA.

The generic ingredient in CLINOLIPID 20% is olive oil; soybean oil. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the olive oil; soybean oil profile page.

Summary for CLINOLIPID 20%

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	2
DailyMed Link:	CLINOLIPID 20% at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for CLINOLIPID 20%

Constraining patent/regulatory exclusivity:

NEW PATIENT POPULATION

NDA:

204508

Dosage:

EMULSION;INTRAVENOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for CLINOLIPID 20%

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

Sponsor	Phase
Baxter Healthcare Corporation	Phase 4

See all CLINOLIPID 20% clinical trials

Pharmacology for CLINOLIPID 20%

Drug Class

Lipid Emulsion

US Patents and Regulatory Information for CLINOLIPID 20%

CLINOLIPID 20% is protected by zero US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on NEW PATIENT POPULATION.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

FDA Regulatory Exclusivity protecting CLINOLIPID 20%

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Baxter Hlthcare Corp	CLINOLIPID 20%	olive oil; soybean oil	EMULSION;INTRAVENOUS	204508-001	Oct 3, 2013		RX	Yes	Yes

Expired US Patents for CLINOLIPID 20%

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Baxter Hlthcare Corp	CLINOLIPID 20%	olive oil; soybean oil	EMULSION;INTRAVENOUS	204508-001	Oct 3, 2013

International Patents for CLINOLIPID 20%

See the table below for patents covering CLINOLIPID 20% around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	2849653
South Korea	0131206
South Africa	8805368
European Patent Office	0302769	LIPID EMULSION FOR PARENTERAL OR ENTERAL NUTRITION
Australia	1972188
Denmark	175448

Supplementary Protection Certificates for CLINOLIPID 20%

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0302769	98C0036	Belgium		PRODUCT NAME: CLOPIDOGREL HYDROGENE SULFATE; REGISTRATION NO/DATE IN FRANCE: EU/1/98 /069/001 DU 19980715; REGISTRATION NO/DATE AT EEC: DU EU/1-/98/069/001
0302769	C980014	Netherlands		PRODUCT NAME: OLIVAE OLEUM EN SOJAE OLEUM, ZODANIG DAT 15 TOT 45% VAN HET TOT AAL AAN VETZUREN ESSENTIELE VETZUREN ZIJN; NAT. REGISTRATION NO/DATE: RVG 16863 19971013; FIRST REGISTRATION: FR 559 258-3, 559 261-4, 559 262-0, 559 263-7 19960807
0302769	SPC/GB98/039	United Kingdom		PRODUCT NAME: PURIFIED SOYABEAN OIL IN COMBINATION WITH PURIFIED OLIVE OIL.; REGISTERED: FR NL 19107 19951128; UK 00116/0313 19980730