MUCINEX Drug Patent Profile

When do Mucinex patents expire, and when can generic versions of Mucinex launch?

Mucinex is a drug marketed by Rb Hlth and is included in three NDAs.

The generic ingredient in MUCINEX is dextromethorphan hydrobromide; guaifenesin. There are twenty-three drug master file entries for this compound. Sixty-five suppliers are listed for this compound. Additional details are available on the dextromethorphan hydrobromide; guaifenesin profile page.

Summary for MUCINEX

US Patents:	0
Applicants:	1
NDAs:	3
Finished Product Suppliers / Packagers:	8
Raw Ingredient (Bulk) Api Vendors:	122
Clinical Trials:	16
Patent Applications:	2,564
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for MUCINEX
Drug Sales Revenues:	Drug sales revenues for MUCINEX
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for MUCINEX
What excipients (inactive ingredients) are in MUCINEX?	MUCINEX excipients list
DailyMed Link:	MUCINEX at DailyMed

See drug prices for MUCINEX

See drug sales revenues for MUCINEX

Recent Clinical Trials for MUCINEX

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

Sponsor	Phase
Vitaccess Ltd	Phase 4
American Health Research	Phase 4
Massachusetts Eye and Ear Infirmary	N/A

See all MUCINEX clinical trials

Pharmacology for MUCINEX

Drug Class	Expectorant
Physiological Effect	Decreased Respiratory Secretion Viscosity Increased Respiratory Secretions

Anatomical Therapeutic Chemical (ATC) Classes for MUCINEX

R05CA	Expectorants
R05C	EXPECTORANTS, EXCL. COMBINATIONS WITH COUGH SUPPRESSANTS
R05	COUGH AND COLD PREPARATIONS
R	Respiratory system

Paragraph IV (Patent) Challenges for MUCINEX

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
MUCINEX	Extended-release Tablets	guaifenesin	600 mg and 1.2 gm	021282	1	2006-06-09

US Patents and Regulatory Information for MUCINEX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Rb Hlth	MUCINEX	guaifenesin	TABLET, EXTENDED RELEASE;ORAL	021282-002	Dec 18, 2002		OTC	Yes	Yes
Rb Hlth	MUCINEX D	guaifenesin; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021585-001	Jun 22, 2004		OTC	Yes	No
Rb Hlth	MUCINEX	guaifenesin	TABLET, EXTENDED RELEASE;ORAL	021282-001	Jul 12, 2002		OTC	Yes	No
Rb Hlth	MUCINEX D	guaifenesin; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021585-002	Jun 22, 2004		OTC	Yes	Yes

Expired US Patents for MUCINEX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Rb Hlth	MUCINEX	guaifenesin	TABLET, EXTENDED RELEASE;ORAL	021282-002	Dec 18, 2002
Rb Hlth	MUCINEX	guaifenesin	TABLET, EXTENDED RELEASE;ORAL	021282-001	Jul 12, 2002
Rb Hlth	MUCINEX	guaifenesin	TABLET, EXTENDED RELEASE;ORAL	021282-001	Jul 12, 2002
Rb Hlth	MUCINEX	guaifenesin	TABLET, EXTENDED RELEASE;ORAL	021282-001	Jul 12, 2002

International Patents for MUCINEX

See the table below for patents covering MUCINEX around the world.

Country	Patent Number	Title	Estimated Expiration
South Africa	200409171	SUSTAINED RELEASE OF GUAIFENESIN COMBINATION DRUGS
Eurasian Patent Organization	007156	ЗАМЕДЛЕННО ВЫСВОБОЖДАЮЩИЕ ЛЕКАРСТВЕННЫЕ КОМПОЗИЦИИ ГВАЙФЕНЕЗИНА (SUSTAINED RELEASE OF GUAIFENESIN COMBINATION DRUGS)
Canada	2405031	FORMULATION ET COMPRIMES DE LIBERATION SOUTENUE DE GUAIFENESINE (GUAIFENESIN SUSTAINED RELEASE FORMULATION AND TABLETS)
Taiwan	I314866