SEMPREX-D Drug Patent Profile

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Semprex-d is a drug marketed by Auxilium Pharms Llc and is included in one NDA.

The generic ingredient in SEMPREX-D is acrivastine; pseudoephedrine hydrochloride. There are two drug master file entries for this compound. Additional details are available on the acrivastine; pseudoephedrine hydrochloride profile page.

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	2
Patent Applications:	1
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for SEMPREX-D
DailyMed Link:	SEMPREX-D at DailyMed

C01CA	Adrenergic and dopaminergic agents
C01C	CARDIAC STIMULANTS EXCL. CARDIAC GLYCOSIDES
C01	CARDIAC THERAPY
C	Cardiovascular system

R01AA	Sympathomimetics, plain
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

R01AB	Sympathomimetics, combinations excl. corticosteroids
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

R01BA	Sympathomimetics
R01B	NASAL DECONGESTANTS FOR SYSTEMIC USE
R01	NASAL PREPARATIONS
R	Respiratory system

R03CA	Alpha- and beta-adrenoreceptor agonists
R03C	ADRENERGICS FOR SYSTEMIC USE
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

R06AX	Other antihistamines for systemic use
R06A	ANTIHISTAMINES FOR SYSTEMIC USE
R06	ANTIHISTAMINES FOR SYSTEMIC USE
R	Respiratory system

S01FB	Sympathomimetics excl. antiglaucoma preparations
S01F	MYDRIATICS AND CYCLOPLEGICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

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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
Auxilium Pharms Llc	SEMPREX-D	acrivastine; pseudoephedrine hydrochloride	CAPSULE;ORAL	019806-001	Mar 25, 1994		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Auxilium Pharms Llc	SEMPREX-D	acrivastine; pseudoephedrine hydrochloride	CAPSULE;ORAL	019806-001	Mar 25, 1994	⤷ Try a Trial	⤷ Try a Trial
Auxilium Pharms Llc	SEMPREX-D	acrivastine; pseudoephedrine hydrochloride	CAPSULE;ORAL	019806-001	Mar 25, 1994	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

See the table below for patents covering SEMPREX-D around the world.

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Country	Patent Number	Title	Estimated Expiration
Australia	1098283		⤷ Try a Trial
Bulgaria	41821	METHOD FOR PREPARING PYRIDYL DERIVATIVES	⤷ Try a Trial
Greece	77407		⤷ Try a Trial
Czechoslovakia	235347	METHOD OF NEW AMINOCOMPOUNDS PRODUCTION	⤷ Try a Trial
Poland	240412		⤷ Try a Trial
Norway	830368		⤷ Try a Trial
Spain	523417		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0085959	SPC/GB93/090	United Kingdom	⤷ Try a Trial	SPC/GB93/090, EXPIRES: 20051230
0085959	SPC/GB93/019	United Kingdom	⤷ Try a Trial	SPC/GB93/019, EXPIRES: 20030922
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description