DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN - Generic Drug Details

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

Diphenhydramine hydrochloride; ibuprofen is the generic ingredient in two branded drugs marketed by Haleon Us Holdings, Aurobindo Pharma Ltd, Bionpharma, and Strides Pharma, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

Seventeen suppliers are listed for this compound.

Summary for DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN

US Patents:	0
Tradenames:	2
Applicants:	4
NDAs:	4
Finished Product Suppliers / Packagers:	17
Clinical Trials:	12
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN
DailyMed Link:	DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN at DailyMed

Recent Clinical Trials for DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN

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

Sponsor	Phase
Guangzhou Kangqi Medical Technology Co., LTD	Phase 1
Overseas Pharmaceuticals, Ltd.	Phase 1
HALEON	Phase 1

See all DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN clinical trials

Pharmacology for DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN

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 DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN

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 DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ADVIL PM	Capsules	diphenhydramine hydrochloride; ibuprofen	200 mg/25 mg	021393		2016-02-16

US Patents and Regulatory Information for DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN

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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
Haleon Us Holdings	ADVIL PM	diphenhydramine hydrochloride; ibuprofen	CAPSULE;ORAL	021393-001	Dec 21, 2005		OTC	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Strides Pharma	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	diphenhydramine hydrochloride; ibuprofen	CAPSULE;ORAL	200888-001	Mar 5, 2012		OTC	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Bionpharma	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	diphenhydramine hydrochloride; ibuprofen	CAPSULE;ORAL	090397-001	Nov 22, 2010		OTC	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Aurobindo Pharma Ltd	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	diphenhydramine hydrochloride; ibuprofen	CAPSULE;ORAL	210676-001	Feb 14, 2019		OTC	No	No	⤷ 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 DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Haleon Us Holdings	ADVIL PM	diphenhydramine hydrochloride; ibuprofen	CAPSULE;ORAL	021393-001	Dec 21, 2005	⤷ Sign Up	⤷ Sign Up
Haleon Us Holdings	ADVIL PM	diphenhydramine hydrochloride; ibuprofen	CAPSULE;ORAL	021393-001	Dec 21, 2005	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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