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ULTIVA Drug Profile

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Which patents cover Ultiva, and what generic alternatives are available?

Ultiva is a drug marketed by Mylan Institutional and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

The generic ingredient in ULTIVA is remifentanil hydrochloride. There are three drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the remifentanil hydrochloride profile page.

Summary for ULTIVA

US Patents:	1
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	18
Clinical Trials:	87
Patent Applications:	2,419
Formulation / Manufacturing:	see details
DailyMed Link:	ULTIVA at DailyMed

Pharmacology for ULTIVA

Drug Class	Opioid Agonist
Mechanism of Action	Full Opioid Agonists

Synonyms for ULTIVA

1-Piperidinepropanoic acid, 4-(methoxycarbonyl)-4-((1-oxopropyl)phenylamino)-, methyl ester, monohydrochloride

132539-07-2

132875-61-7 (Parent)

3-[methoxycarbonyl-4-[(1-oxopropyl)phenylamino]1-piperidine]propanoic acid methyl ester hydrochloride

4-(Methoxycarbonyl)-4-[(1-oxopropyl)phenylamino]-1-piperidinepropanoic Acid Methyl Ester Hydrochloride

4-Carboxy-4-(N-phenylpropionamido)-1-piperidine propionic acid, dimethyl ester, monohydrochloride

5V444H5WIC

AC1L1TZ5

AC1Q3E9W

C20H28N2O5.HCl

CHEBI:32091

CHEMBL1201120

D01177

DTXSID50157614

FT-0674340

GI 87084B

GI-87084B

HE306791

LS-172838

methyl 1-(3-methoxy-3-oxopropyl)-4-(N-propanoylanilino)piperidine-4-carboxylate hydrochloride

methyl-1-(3-methoxy-3-oxopropyl)-4-[phenyl(propanoyl)amino]piperidin-4-carboxylathydrochlorid

Remifentanil HCl

REMIFENTANIL HYDROCHLORIDE

Remifentanil hydrochloride (JAN/USAN)

Remifentanil hydrochloride [USAN]

Remifentanil hydrochloride solution, 100 mug/mL in methanol (as free base), certified reference material

Remifentanil hydrochloride, >=97% (HPLC), powder

Remifentanil hydrochloride, European Pharmacopoeia (EP) Reference Standard

remifentanil monohydrochloride

Remifentanyl Hydrochloride

SCHEMBL41242

UNII-5V444H5WIC

US Patents and Regulatory Information for ULTIVA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mylan Institutional	ULTIVA	remifentanil hydrochloride	INJECTABLE;INJECTION	020630-001	Jul 12, 1996	AP	RX	Yes	No
Mylan Institutional	ULTIVA	remifentanil hydrochloride	INJECTABLE;INJECTION	020630-002	Jul 12, 1996	AP	RX	Yes	No
Mylan Institutional	ULTIVA	remifentanil hydrochloride	INJECTABLE;INJECTION	020630-003	Jul 12, 1996	AP	RX	Yes	Yes

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Expired US Patents for ULTIVA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mylan Institutional	ULTIVA	remifentanil hydrochloride	INJECTABLE;INJECTION	020630-002	Jul 12, 1996
Mylan Institutional	ULTIVA	remifentanil hydrochloride	INJECTABLE;INJECTION	020630-002	Jul 12, 1996
Mylan Institutional	ULTIVA	remifentanil hydrochloride	INJECTABLE;INJECTION	020630-003	Jul 12, 1996
Mylan Institutional	ULTIVA	remifentanil hydrochloride	INJECTABLE;INJECTION	020630-001	Jul 12, 1996

Paragraph IV (Patent) Challenges for ULTIVA

Drugname	Dosage	Strength	RLD	Submissiondate
	for Injection	1 mg/vial, 2 mg/vial and 5 mg/vial		2013-12-27

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