Lidocaine; prilocaine - Generic Drug Details

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What are the generic sources for lidocaine; prilocaine and what is the scope of freedom to operate?

Lidocaine; prilocaine is the generic ingredient in three branded drugs marketed by Teva Branded Pharm, Alembic, Encube, Fougera Pharms, Hikma, Padagis Us, Pai Holdings Pharm, Rhodes Pharms, Astrazeneca, and Dentsply Pharm, and is included in ten NDAs. Additional information is available in the individual branded drug profile pages.

Ten suppliers are listed for this compound.

Summary for lidocaine; prilocaine

US Patents:	0
Tradenames:	3
Applicants:	10
NDAs:	10
Finished Product Suppliers / Packagers:	10
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	75
DailyMed Link:	lidocaine; prilocaine at DailyMed

Recent Clinical Trials for lidocaine; prilocaine

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

Sponsor	Phase
Indonesia Endowment Fund for Education	Phase 4
Universitas Sebelas Maret	Phase 4
Cairo University	N/A

See all lidocaine; prilocaine clinical trials

Pharmacology for lidocaine; prilocaine

Drug Class	Amide Local Anesthetic Antiarrhythmic
Physiological Effect	Local Anesthesia

Anatomical Therapeutic Chemical (ATC) Classes for lidocaine; prilocaine

C01BB	Antiarrhythmics, class Ib
C01B	ANTIARRHYTHMICS, CLASS I AND III
C01	CARDIAC THERAPY
C	Cardiovascular system

C05AD	Local anesthetics
C05A	AGENTS FOR TREATMENT OF HEMORRHOIDS AND ANAL FISSURES FOR TOPICAL USE
C05	VASOPROTECTIVES
C	Cardiovascular system

D04AB	Anesthetics for topical use
D04A	ANTIPRURITICS, INCL. ANTIHISTAMINES, ANESTHETICS, ETC.
D04	ANTIPRURITICS, INCL. ANTIHISTAMINES, ANESTHETICS, ETC.
D	Dermatologicals

N01BB	Amides
N01B	ANESTHETICS, LOCAL
N01	ANESTHETICS
N	Nervous system

N01BB	Amides
N01B	ANESTHETICS, LOCAL
N01	ANESTHETICS
N	Nervous system

R02AD	Anesthetics, local
R02A	THROAT PREPARATIONS
R02	THROAT PREPARATIONS
R	Respiratory system

S01HA	Local anesthetics
S01H	LOCAL ANESTHETICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

S02DA	Analgesics and anesthetics
S02D	OTHER OTOLOGICALS
S02	OTOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for lidocaine; prilocaine

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Fougera Pharms	LIDOCAINE AND PRILOCAINE	lidocaine; prilocaine	CREAM;TOPICAL	076453-001	Aug 18, 2003	AB	RX	No	Yes	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Hikma	LIDOCAINE AND PRILOCAINE	lidocaine; prilocaine	CREAM;TOPICAL	076290-001	Sep 25, 2003		DISCN	No	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Teva Branded Pharm	EMLA	lidocaine; prilocaine	CREAM;TOPICAL	019941-001	Dec 30, 1992		DISCN	Yes	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Pai Holdings Pharm	LIDOCAINE AND PRILOCAINE	lidocaine; prilocaine	CREAM;TOPICAL	205887-001	Jun 29, 2018	AB	RX	No	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Astrazeneca	EMLA	lidocaine; prilocaine	DISC;TOPICAL	020962-001	Feb 4, 1998		DISCN	No	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Encube	LIDOCAINE AND PRILOCAINE	lidocaine; prilocaine	CREAM;TOPICAL	076320-001	Aug 27, 2003	AB	RX	No	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for lidocaine; prilocaine

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Teva Branded Pharm	EMLA	lidocaine; prilocaine	CREAM;TOPICAL	019941-001	Dec 30, 1992	4,529,601	⤷ Subscribe
Dentsply Pharm	ORAQIX	lidocaine; prilocaine	GEL;PERIODONTAL	021451-001	Dec 19, 2003	6,031,007	⤷ Subscribe
Teva Branded Pharm	EMLA	lidocaine; prilocaine	CREAM;TOPICAL	019941-001	Dec 30, 1992	4,562,060	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for lidocaine; prilocaine

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Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Recordati Ireland Ltd.	Fortacin	lidocaine, prilocaine	EMEA/H/C/002693 Treatment of primary premature ejaculation in adult men.	Authorised	no	no	no	2013-11-15
Plethora Pharma Solutions Limited	Senstend	lidocaine, prilocaine	EMEA/H/C/005298 Senstend is indicated for the treatment of primary premature ejaculation in adult men.	Withdrawn	no	no	no	2019-11-14
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

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