ADVIL PM Drug Patent Profile

Which patents cover Advil Pm, and when can generic versions of Advil Pm launch?

Advil Pm is a drug marketed by Glaxosmithkline and is included in two NDAs.

The generic ingredient in ADVIL PM is diphenhydramine citrate; ibuprofen. There are twenty-three drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the diphenhydramine citrate; ibuprofen profile page.

Summary for ADVIL PM

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	2
Patent Applications:	21
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ADVIL PM
What excipients (inactive ingredients) are in ADVIL PM?	ADVIL PM excipients list
DailyMed Link:	ADVIL PM at DailyMed

Pharmacology for ADVIL PM

Drug Class	Histamine-1 Receptor Antagonist Nonsteroidal Anti-inflammatory Drug
Mechanism of Action	Cyclooxygenase Inhibitors Histamine H1 Receptor Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for ADVIL PM

C01EB	Other cardiac preparations
C01E	OTHER CARDIAC PREPARATIONS
C01	CARDIAC THERAPY
C	Cardiovascular system

D04AA	Antihistamines for topical use
D04A	ANTIPRURITICS, INCL. ANTIHISTAMINES, ANESTHETICS, ETC.
D04	ANTIPRURITICS, INCL. ANTIHISTAMINES, ANESTHETICS, ETC.
D	Dermatologicals

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

R02AX	Other throat preparations
R02A	THROAT PREPARATIONS
R02	THROAT PREPARATIONS
R	Respiratory system

R06AA	Aminoalkyl ethers
R06A	ANTIHISTAMINES FOR SYSTEMIC USE
R06	ANTIHISTAMINES FOR SYSTEMIC USE
R	Respiratory system

Paragraph IV (Patent) Challenges for ADVIL PM

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ADVIL PM	Tablets	diphenhydramine citrate; ibuprofen	200 mg/38 mg	021394	1	2017-12-28
ADVIL PM	Capsules	diphenhydramine hydrochloride; ibuprofen	200 mg/25 mg	021393		2016-02-16

US Patents and Regulatory Information for ADVIL PM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glaxosmithkline	ADVIL PM	diphenhydramine hydrochloride; ibuprofen	CAPSULE;ORAL	021393-001	Dec 21, 2005		OTC	Yes	Yes
Glaxosmithkline	ADVIL PM	diphenhydramine citrate; ibuprofen	TABLET;ORAL	021394-001	Dec 21, 2005		OTC	Yes	Yes

Expired US Patents for ADVIL PM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline	ADVIL PM	diphenhydramine hydrochloride; ibuprofen	CAPSULE;ORAL	021393-001	Dec 21, 2005
Glaxosmithkline	ADVIL PM	diphenhydramine citrate; ibuprofen	TABLET;ORAL	021394-001	Dec 21, 2005
Glaxosmithkline	ADVIL PM	diphenhydramine hydrochloride; ibuprofen	CAPSULE;ORAL	021393-001	Dec 21, 2005

International Patents for ADVIL PM

See the table below for patents covering ADVIL PM around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	2004521104
Japan	4402882
Denmark	1363608
Canada	2434484	COMPOSITIONS COMPRENANT DE L'IBUPROFENE ET DE LA DIPHEHYDRAMINE DESTINEES A TRAITER LES TROUBLES DU SOMMEIL LIES A LA DOULEUR (COMPOSITIONS COMPRISING IBUPROFEN AND DIPHENHYDRAMINE TO TREAT PAIN-ASSOCIATED SLEEP DISTURBANCES)
European Patent Office	1363608	COMPOSITIONS CONTENANT DE L'IBUPROFENE ET DU DIPHENHYDRAMINE ET LEUR UTILISATION POUR LE TRAITEMENT DES TROUBLES DU SOMMEIL (FORMULATIONS COMPRISING IBUPROFEN AND DIPHENHYDRAMINE AND THE USE THEREOF FOR THE TREATMENT OF SLEEP DISTURBANCES)