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Last Updated: May 4, 2024

Merck Company Profile


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Summary for Merck

Drugs and US Patents for Merck

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 9,358,297 ⤷  Try a Trial Y ⤷  Try a Trial
Merck Sharp Dohme BELSOMRA suvorexant TABLET;ORAL 204569-002 Aug 13, 2014 RX Yes No 7,951,797 ⤷  Try a Trial Y Y ⤷  Try a Trial
Merck Kgaa LEVOTHYROXINE SODIUM levothyroxine sodium TABLET;ORAL 076752-005 Jun 16, 2005 DISCN No No ⤷  Try a Trial ⤷  Try a Trial
Merck PRIMAXIN cilastatin sodium; imipenem INJECTABLE;INJECTION 062756-001 Jan 8, 1987 DISCN No No ⤷  Try a Trial ⤷  Try a Trial
Merck DECADERM dexamethasone GEL;TOPICAL 013538-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial
Merck DOLOBID diflunisal TABLET;ORAL 018445-001 Apr 19, 1982 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial
Merck DIUPRES-250 chlorothiazide; reserpine TABLET;ORAL 011635-003 Aug 26, 1987 DISCN No No ⤷  Try a Trial ⤷  Try a Trial
>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 Merck

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck EMEND aprepitant CAPSULE;ORAL 021549-003 Jun 30, 2006 6,096,742 ⤷  Try a Trial
Merck PEPCID RPD famotidine TABLET, ORALLY DISINTEGRATING;ORAL 020752-001 May 28, 1998 4,283,408*PED ⤷  Try a Trial
Merck Sharp Dohme DUTREBIS lamivudine; raltegravir potassium TABLET;ORAL 206510-001 Feb 6, 2015 7,820,660 ⤷  Try a Trial
Merck Sharp Dohme REBETOL ribavirin CAPSULE;ORAL 020903-001 Jun 3, 1998 6,337,090*PED ⤷  Try a Trial
Merck EMEND aprepitant CAPSULE;ORAL 021549-002 Mar 26, 2003 5,145,684 ⤷  Try a Trial
Merck DOLOBID diflunisal TABLET;ORAL 018445-001 Apr 19, 1982 3,714,226 ⤷  Try a Trial
Merck Sharp Dohme JANUVIA sitagliptin phosphate TABLET;ORAL 021995-001 Oct 16, 2006 6,890,898 ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for MERCK drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Capsules 140 mg and 180 mg ➤ Subscribe 2008-03-24
➤ Subscribe Delayed-release Tablets 100 mg ➤ Subscribe 2014-06-16
➤ Subscribe Tablets 5 mg ➤ Subscribe 2006-06-21
➤ Subscribe Tablets 25 mg, 50 mg and 100 mg ➤ Subscribe 2010-10-18
➤ Subscribe Tablets 100 mg/10 mg and 100 mg/40 mg ➤ Subscribe 2012-06-25
➤ Subscribe Injection 115 mg/vial ➤ Subscribe 2012-01-25
➤ Subscribe for Oral Suspension 125 mg/Kit ➤ Subscribe 2016-11-23
➤ Subscribe Oral Solution 70 mg/75 mL ➤ Subscribe 2007-09-07
➤ Subscribe for Injection 200 mcg/vial ➤ Subscribe 2015-05-01
➤ Subscribe Oral Suspension 40 mg/mL ➤ Subscribe 2011-02-28
➤ Subscribe Injection 18 mg/mL, 16.7 mL vials ➤ Subscribe 2015-11-24
➤ Subscribe Orally Disintegrating Tablets 2.5 mg and 5 mg ➤ Subscribe 2006-06-21
➤ Subscribe Tablets 100 mg/10 mg and 100 mg/40 mg ➤ Subscribe 2012-06-19
➤ Subscribe Capsule 40 mg, 80 mg and 125 mg ➤ Subscribe 2008-11-03
➤ Subscribe Tablets 50 mg/10 mg, 50 mg/20 mg, and 50 mg/40 mg ➤ Subscribe 2012-11-06
➤ Subscribe Injection 150 mg/vial ➤ Subscribe 2012-01-25
➤ Subscribe For Injection 50 mg/vial and 70 mg/vial ➤ Subscribe 2009-06-26
➤ Subscribe for Injection 100 mcg/vial and 500 mcg/vial ➤ Subscribe 2015-04-14

Supplementary Protection Certificates for Merck Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2666774 CA 2020 00037 Denmark ⤷  Try a Trial PRODUCT NAME: RELEBACTAM, OPTIONALLY IN THE FORM OF THE MONOHYDRATE, IMIPENEM AND CILASTATIN, OPTIONALLY IN THE FORM OF THE SODIUM SALT; REG. NO/DATE: EU/1/19/1420 20200217
1385870 C 2011 014 Romania ⤷  Try a Trial PRODUCT NAME: BOCEPREVIR(1R,2S,5S)-N-[3-AMINO-1-(CICLOBUTILMETIL)-2,3-DIOXOPROPIL]-3-[(2S)-2[[[(1,1-DIMETILETIL)AMINO]CARBONIL]AMINO]-3,3-DIMETIL-1-OXOBUTIL]-6,6-DIMETIL-3-AZABICICLO[3.1.0]HEXAN-2-CARBOXAMIDA; NATIONAL AUTHORISATION NUMBER: RO EU/1/11/704/001; DATE OF NATIONAL AUTHORISATION: 20110718; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/11/704/001; DATE OF FIRST AUTHORISATION IN EEA: 20110718
1412357 DO 77; 5006-2008 Slovakia ⤷  Try a Trial PRODUCT NAME: SITAGLIPTIN A METFORMIN; REGISTRATION NO/DATE: EU/1/08/455/001-014 20080716
0443983 C00443983/03 Switzerland ⤷  Try a Trial PRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009
0733366 SPC/GB98/031 United Kingdom ⤷  Try a Trial PRODUCT NAME: 2-BUTYL-4-CHLORO-1-((2'-(1H-TETRAZOL-5-YL) BIPHENYL-4-YL)-METHYL)-5-(HYDROXYMETHYL)IMIDAZOLE (LOSARTAN),OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN PARTICULAR A POTASSIUM SALT( LOSARTAN POTASSIUM) AND HYDROCHLOROTHIAZIDE,; REGISTERED: FR 338520.7 19950215; FR 558453.7 19950215; UK 00025/0338 19960412
0509752 49/1999 Austria ⤷  Try a Trial PRODUCT NAME: DORZOLAMID ODER EIN OPHTHALMOLOGISCH ANNEHMBARES SALZ DAVON, VORZUGSWEISE DORZOLAMIDHYDROCHLORID, UND TIMOLOL ODER EIN OPHTHALMOLOGISCH ANNEHMBARES SALZ DAVON, VORZUGSWEISE TIMOLOLMALEAT; NAT. REGISTRATION NO/DATE: 1-22701, 1-22702 19980828; FIRST REGISTRATION: DK 9794 19980306
0509752 SPC/GB99/043 United Kingdom ⤷  Try a Trial PRODUCT NAME: DORZOLAMIDE OR AN OPHTHALMOLOGICALLY ACCEPTABLE SALT THEREOF, PREFERABLY DORZOLAMIDE HYDROCHOLORIDE, PLUS TIMOLOL OR AN OPHTHAMOLOGICALLY ACCEPTABLE SALT THEREOF, PREFERABLY TIMOLOL MALEATE; REGISTERED: DK 19045 19980306; UK PL 00025/0373 19980804
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
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