Merck Sharp Dohme Company Profile

What is the competitive landscape for MERCK SHARP DOHME, and when can generic versions of MERCK SHARP DOHME drugs launch?

MERCK SHARP DOHME has twenty-three approved drugs.

There are twenty-five US patents protecting MERCK SHARP DOHME drugs.

There are six hundred and ninety patent family members on MERCK SHARP DOHME drugs in sixty-three countries and one hundred and twenty-seven supplementary protection certificates in nineteen countries.

Summary for Merck Sharp Dohme

International Patents:	690
US Patents:	25
Tradenames:	19
Ingredients:	19
NDAs:	23

Drugs and US Patents for Merck Sharp Dohme

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Merck Sharp Dohme	NOXAFIL	posaconazole	SOLUTION;INTRAVENOUS	205596-001	Mar 13, 2014	AP	RX	Yes	Yes
Merck Sharp Dohme	NOXAFIL	posaconazole	SOLUTION;INTRAVENOUS	205596-001	Mar 13, 2014	AP	RX	Yes	Yes
Merck Sharp Dohme	VERQUVO	vericiguat	TABLET;ORAL	214377-001	Jan 19, 2021		RX	Yes	No	9,604,948		Y	Y
Merck Sharp Dohme	CRIXIVAN	indinavir sulfate	CAPSULE;ORAL	020685-001	Mar 13, 1996		DISCN	Yes	No
Merck Sharp Dohme	STROMECTOL	ivermectin	TABLET;ORAL	050742-001	Nov 22, 1996		DISCN	Yes	No
Merck Sharp Dohme	PREVYMIS	letermovir	TABLET;ORAL	209939-001	Nov 8, 2017		RX	Yes	No
Merck Sharp Dohme	BELSOMRA	suvorexant	TABLET;ORAL	204569-003	Aug 13, 2014		RX	Yes	No	10,098,892		Y

Expired US Patents for Merck Sharp Dohme

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Merck Sharp Dohme	JANUVIA	sitagliptin phosphate	TABLET;ORAL	021995-002	Oct 16, 2006	6,303,661
Merck Sharp Dohme	CRIXIVAN	indinavir sulfate	CAPSULE;ORAL	020685-006	Apr 19, 2000	6,689,761
Merck Sharp Dohme	TEMODAR	temozolomide	POWDER;INTRAVENOUS	022277-001	Feb 27, 2009	7,786,118
Merck Sharp Dohme	CRIXIVAN	indinavir sulfate	CAPSULE;ORAL	020685-003	Mar 13, 1996	5,413,999
Merck Sharp Dohme	REBETOL	ribavirin	CAPSULE;ORAL	020903-001	Jun 3, 1998	6,063,772*PED
Merck Sharp Dohme	CLARINEX	desloratadine	SOLUTION;ORAL	021300-001	Sep 1, 2004	6,514,520*PED
Merck Sharp Dohme	JUVISYNC	simvastatin; sitagliptin phosphate	TABLET;ORAL	202343-001	Oct 7, 2011	7,459,428

Paragraph IV (Patent) Challenges for MERCK SHARP DOHME drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Oral Suspension	40 mg/mL		2011-02-28
	Injection	18 mg/mL, 16.7 mL vials		2015-11-24
	Orally Disintegrating Tablets	2.5 mg and 5 mg		2006-06-21
	Tablets	100 mg/10 mg and 100 mg/40 mg		2012-06-19
	Tablets	50 mg/10 mg, 50 mg/20 mg, and 50 mg/40 mg		2012-11-06
	Capsules	140 mg and 180 mg		2008-03-24
	Delayed-release Tablets	100 mg		2014-06-16
	Tablets	5 mg		2006-06-21
	Tablets	25 mg, 50 mg and 100 mg		2010-10-18
	Tablets	100 mg/10 mg and 100 mg/40 mg		2012-06-25

International Patents for Merck Sharp Dohme Drugs

Country	Patent Number	Estimated Expiration
Russian Federation	2004125279
Australia	2006252553
Brazil	PI0905080
Mexico	2014010364
Brazil	112014025041
Chile	2014001339
Malaysia	164356

Supplementary Protection Certificates for Merck Sharp Dohme Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1441735	08C0026	France		PRODUCT NAME: RALTEGRAVIR POTASSIUM; REGISTRATION NO/DATE: EU/1/07/436/001 20080102
1441735	319	Finland
1622880	C 2018 027	Romania		PRODUCT NAME: LETERMOVIR SAU SAREA SA, SOLVATUL SAU, SAU SOLVATUL SARII SALE; NATIONAL AUTHORISATIONNUMBER: EU/1/17/1245; DATE OF NATIONAL AUTHORISATION: 20180108; NUMBER OF FIRST AUTHORISATION IN EU ROPEAN ECONOMIC AREA (EEA): EU/1/17/1245; DATE OF FIRST AUTHORISATION IN EEA: 20180108
1412357	122007000056	Germany		PRODUCT NAME: SITAGLIPTIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE FUER SITAGLIPTINPHOSPHAT-MONOHYDRAT; REGISTRATION NO/DATE: EU/1/07/383/001-018 20070321
1620113	C 2015 036	Romania		PRODUCT NAME: IVERMECTINA; NATIONAL AUTHORISATION NUMBER: RO7674/2015/01, RO7674/2015/02, RO7674/2015/03, RO7674/2015/04, RO7674/2015/05; DATE OF NATIONAL AUTHORISATION: 20150526; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): MALTA MA117/01101; DATE OF FIRST AUTHORISATION IN EEA: 20150402
2576547	PA2021518,C2576547	Lithuania		PRODUCT NAME: VERICIGUATAS IR JO DRUSKOS, SOLVATAI IR DRUSKU SOLVATAI ; REGISTRATION NO/DATE: EU/1/21/1561 20210716
1622880	122018000080	Germany		PRODUCT NAME: LETERMOVIR ODER DESSEN SALZ, SOLVAT ODER SOLVAT DES SALZES; REGISTRATION NO/DATE: EU/1/17/1245 20180108

Similar Applicant Names

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

• Merck
• Merck And Co Inc
• Merck Kgaa
• Merck Sharp Dohme