Merck Sharp Dohme Company Profile

What is the competitive landscape for MERCK SHARP DOHME, and what generic alternatives to MERCK SHARP DOHME drugs are available?

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	TEMODAR	temozolomide	CAPSULE;ORAL	021029-004	Aug 11, 1999		DISCN	Yes	No
Merck Sharp Dohme	PREVYMIS	letermovir	SOLUTION;INTRAVENOUS	209940-001	Nov 8, 2017		RX	Yes	Yes	10,603,384		Y
Merck Sharp Dohme	PREVYMIS	letermovir	SOLUTION;INTRAVENOUS	209940-002	Nov 8, 2017		RX	Yes	Yes
Merck Sharp Dohme	DUTREBIS	lamivudine; raltegravir potassium	TABLET;ORAL	206510-001	Feb 6, 2015		DISCN	No	No	7,754,731*PED				Y
Merck Sharp Dohme	BELSOMRA	suvorexant	TABLET;ORAL	204569-004	Aug 13, 2014		RX	Yes	Yes	7,951,797		Y	Y
Merck Sharp Dohme	TEMODAR	temozolomide	CAPSULE;ORAL	021029-001	Aug 11, 1999		DISCN	Yes	No
Merck Sharp Dohme	NOXAFIL	posaconazole	SOLUTION;INTRAVENOUS	205596-001	Mar 13, 2014	AP	RX	Yes	Yes	9,023,790		Y

Expired US Patents for Merck Sharp Dohme

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Merck Sharp Dohme	JUVISYNC	simvastatin; sitagliptin phosphate	TABLET;ORAL	202343-004	Sep 18, 2012	7,078,381
Merck Sharp Dohme	PEPCID PRESERVATIVE FREE IN PLASTIC CONTAINER	famotidine	INJECTABLE;INJECTION	020249-001	Feb 18, 1994	4,283,408*PED
Merck Sharp Dohme	DUTREBIS	lamivudine; raltegravir potassium	TABLET;ORAL	206510-001	Feb 6, 2015	7,820,660
Merck Sharp Dohme	TEMODAR	temozolomide	CAPSULE;ORAL	021029-003	Aug 11, 1999	5,260,291*PED
Merck Sharp Dohme	REBETOL	ribavirin	CAPSULE;ORAL	020903-001	Jun 3, 1998	6,472,373*PED
Merck Sharp Dohme	REBETOL	ribavirin	CAPSULE;ORAL	020903-001	Jun 3, 1998	6,461,605*PED
Merck Sharp Dohme	CRIXIVAN	indinavir sulfate	CAPSULE;ORAL	020685-005	Dec 17, 1998	6,689,761

Paragraph IV (Patent) Challenges for MERCK SHARP DOHME drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	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
	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

International Patents for Merck Sharp Dohme Drugs

Country	Patent Number	Estimated Expiration
European Patent Office	3391890
Singapore	10201604196V
South Korea	20090087110
New Zealand	523782
Norway	20076613
China	1498224
Denmark	1654263

Supplementary Protection Certificates for Merck Sharp Dohme Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1412357	106 4-2007	Slovakia		PRODUCT NAME: SITAGLIPTIN; REGISTRATION NO/DATE: EU/1/07/383/001 - EU/1/07/383/018 20070321
1441735	30/2008	Austria		PRODUCT NAME: RALTEGRAVIR ODER DESSEN PHARMAZEUTISCH ANNEHMBAREN SALZE, INSBESONDERE DAS KALIUMSALZ; REGISTRATION NO/DATE: EU/1/07/436 (MITTEILUNG) 20071220
1385870	C01385870/01	Switzerland		PRODUCT NAME: BOCEPREVIR; REGISTRATION NO/DATE: SWISSMEDIC 62105 31.10.2011
1412357	50/2008	Austria		PRODUCT NAME: SITAGLIPTIN, GEGEBENENFALLS IN DER FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE ALS MONOPHOSPHAT, UND METFORMIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE DES HYDROCHLORIDS; NAT. REGISTRATION NO/DATE: EU/1/08/455/001-014, EU/1/08/456/001-014, EU/1/08/457/001-014 20080716; FIRST REGISTRATION: CH 58450 01-03 20080408
1620113	PA2015033	Lithuania		PRODUCT NAME: IVERMECTINUM; NAT. REGISTRATION NO/DATE: LT/1/15/3726/001 - LT/1/15/3726/005 20150513; FIRST REGISTRATION: MA117/01101 20150402
1441735	C20080001 00016	Estonia		PRODUCT NAME: ISENTRESS; REG NO/DATE: 20.12.2007 C(2007)6801
1412357	300287	Netherlands		PRODUCT NAME: SITAGLIPTINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER SITAGLIPTINE FOSFAAT MONOHYDRAAT; REGISTRATION NO/DATE: EU/1/07/383/001-018 20070323

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