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Last Updated: November 21, 2024

Ibuprofen; pseudoephedrine hydrochloride - Generic Drug Details


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What are the generic sources for ibuprofen; pseudoephedrine hydrochloride and what is the scope of patent protection?

Ibuprofen; pseudoephedrine hydrochloride is the generic ingredient in six branded drugs marketed by Haleon Us Holdings, Aurobindo Pharma, J And J Consumer Inc, Perrigo, Aurobindo Pharma Ltd, Contract Pharmacal, Dr Reddys Labs Ltd, and Ohm Labs, and is included in eleven NDAs. Additional information is available in the individual branded drug profile pages.

Fourteen suppliers are listed for this compound.

Summary for ibuprofen; pseudoephedrine hydrochloride
Recent Clinical Trials for ibuprofen; pseudoephedrine hydrochloride

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

SponsorPhase
Institut für Pharmakologie und Präventive MedizinPhase 1
Pharma Medica Research, Inc.Phase 1
Boehringer IngelheimPhase 1

See all ibuprofen; pseudoephedrine hydrochloride clinical trials

Pharmacology for ibuprofen; pseudoephedrine hydrochloride
Anatomical Therapeutic Chemical (ATC) Classes for ibuprofen; pseudoephedrine hydrochloride
C01CA Adrenergic and dopaminergic agents
C01C CARDIAC STIMULANTS EXCL. CARDIAC GLYCOSIDES
C01 CARDIAC THERAPY
C Cardiovascular system
C01EB Other cardiac preparations
C01E OTHER CARDIAC PREPARATIONS
C01 CARDIAC THERAPY
C Cardiovascular system
G02CC Antiinflammatory products for vaginal administration
G02C OTHER GYNECOLOGICALS
G02 OTHER GYNECOLOGICALS
G Genito-urinary system and sex hormones
M01AE Propionic acid derivatives
M01A ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
M01 ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
M Musculo-skeletal system
M02AA Antiinflammatory preparations, non-steroids for topical use
M02A TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
M02 TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
M Musculo-skeletal 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
R02AX Other throat preparations
R02A THROAT PREPARATIONS
R02 THROAT PREPARATIONS
R Respiratory system
R03CA Alpha- and beta-adrenoreceptor agonists
R03C ADRENERGICS FOR SYSTEMIC USE
R03 DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R Respiratory system
S01FB Sympathomimetics excl. antiglaucoma preparations
S01F MYDRIATICS AND CYCLOPLEGICS
S01 OPHTHALMOLOGICALS
S Sensory organs

US Patents and Regulatory Information for ibuprofen; pseudoephedrine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ohm Labs IBUPROHM COLD AND SINUS ibuprofen; pseudoephedrine hydrochloride TABLET;ORAL 074567-001 Apr 17, 2001 OTC No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Dr Reddys Labs Ltd IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE ibuprofen; pseudoephedrine hydrochloride TABLET;ORAL 077628-001 Aug 14, 2006 OTC No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Haleon Us Holdings ADVIL COLD AND SINUS ibuprofen; pseudoephedrine hydrochloride TABLET;ORAL 019771-001 Sep 19, 1989 OTC Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Contract Pharmacal IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE ibuprofen; pseudoephedrine hydrochloride TABLET;ORAL 075588-001 Apr 8, 2002 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Aurobindo Pharma IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE ibuprofen; pseudoephedrine hydrochloride CAPSULE;ORAL 209235-001 Dec 1, 2017 OTC No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Haleon Us Holdings CHILDREN'S ADVIL COLD ibuprofen; pseudoephedrine hydrochloride SUSPENSION;ORAL 021373-001 Apr 18, 2002 OTC No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
J And J Consumer Inc CHILDREN'S MOTRIN COLD ibuprofen; pseudoephedrine hydrochloride SUSPENSION;ORAL 021128-001 Aug 1, 2000 OTC Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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 ibuprofen; pseudoephedrine hydrochloride

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