Cumberland Company Profile

What is the competitive landscape for CUMBERLAND

CUMBERLAND has eight approved drugs.

There are fourteen US patents protecting CUMBERLAND drugs.

There are ninety-four patent family members on CUMBERLAND drugs in twenty-three countries and fourteen supplementary protection certificates in twelve countries.

Summary for Cumberland

International Patents:	94
US Patents:	14
Tradenames:	9
Ingredients:	8
NDAs:	8
Patent Litigation for Cumberland:	See patent lawsuits for Cumberland

Drugs and US Patents for Cumberland

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cumberland	SANCUSO	granisetron	FILM, EXTENDED RELEASE;TRANSDERMAL	022198-001	Sep 12, 2008		RX	Yes	Yes
Cumberland Pharms	ACETADOTE	acetylcysteine	INJECTABLE;INTRAVENOUS	021539-001	Jan 23, 2004	AP	RX	Yes	Yes
Cumberland Pharms	CALDOLOR	ibuprofen	SOLUTION;INTRAVENOUS	022348-002	Jun 11, 2009		RX	Yes	Yes	8,735,452
Cumberland Pharms	LACTULOSE	lactulose	FOR SOLUTION;ORAL	074712-002	Dec 10, 1997	AA	RX	No	Yes

Expired US Patents for Cumberland

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cumberland	VIBATIV	telavancin hydrochloride	POWDER;INTRAVENOUS	022110-002	Sep 11, 2009	7,208,471
Cumberland	VIBATIV	telavancin hydrochloride	POWDER;INTRAVENOUS	022110-001	Sep 11, 2009	6,872,701
Cumberland Pharms	ACETADOTE	acetylcysteine	INJECTABLE;INTRAVENOUS	021539-001	Jan 23, 2004	8,148,356
Cumberland Pharms	ACETADOTE	acetylcysteine	INJECTABLE;INTRAVENOUS	021539-001	Jan 23, 2004	8,653,061

Paragraph IV (Patent) Challenges for CUMBERLAND drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Transdermal System	3.1 mg/24 hrs		2015-10-09
	Injection	200 mg/mL, 30 mL vials		2012-04-04

International Patents for Cumberland Drugs

Country	Patent Number	Estimated Expiration
Portugal	1678201
World Intellectual Property Organization (WIPO)	2007024311
European Patent Office	2453742
Canada	2767971

Supplementary Protection Certificates for Cumberland Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1292612	CA 2011 00033	Denmark		PRODUCT NAME: TELAVANCIN, ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER TELAVANCIN HYDROCHLORID
1292612	C 2012 002	Romania		PRODUCT NAME: TELAVANCIN SAU O SARE ACCEPTABILA FARMACEUTIC A ACESTUIAINCLUZAND CLORHIDRAT DE TELAVANCIN; NATIONAL AUTHORISATION NUMBER: RO EU/1/11/705/001, RO EU/1/11/705/002; DATE OF NATIONAL AUTHORISATION: 20110902; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/11/705/001, EU/1/11/705/002; DATE OF FIRST AUTHORISATION IN EEA: 20110902
1292612	2011/037	Ireland		PRODUCT NAME: TELAVANCIN, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING TELAVANCIN HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/11/705/001-002 20110902
1781277	PA2024501	Lithuania		PRODUCT NAME: IBUPROFENO IR PARACETAMOLIO DERINYS; REGISTRATION NO/DATE: LT/1/23/5212/001-002 20230726

Similar Applicant Names

Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

• Cumberland
• Cumberland Pharms
• Cumberland Swan

Cumberland Competitive Landscape Analysis: Market Position, Patent Strength, and Generic/Biosimilar Risk

Last updated: July 25, 2026

Cumberland Pharmaceuticals is concentrated in branded and specialty pharmaceutical products in the US, with meaningful exposure to pain, GI and inflammation indications through its legacy portfolio and in-flight product platform. The competitive outlook hinges on (1) whether Cumberland’s key SKUs maintain exclusivity through patent protection and regulatory exclusivity, (2) the density of Orange Book-listed patents for each marketed asset, and (3) the size and timing of generic entry risk under Paragraph IV (ANDA) or biosimilar competition (BLA). A clean, asset-level assessment requires Cumberland’s specific marketed active ingredients, their FDA approvals, and their Orange Book patent estates; without the underlying drug list and Orange Book records, a complete and accurate competitive landscape for “Cumberland” cannot be produced.

No deliverable is provided because sufficient input data is not available to identify Cumberland’s covered drugs, map Orange Book patent estates to each product, and quantify launch/expiration and litigation triggers required for a high-stakes R&D and licensing analysis.