Merck Company Profile
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What is the competitive landscape for MERCK, and when can generic versions of MERCK drugs launch?
MERCK has ninety-two approved drugs.
There are twenty-six US patents protecting MERCK drugs.
There are seven hundred and thirty-five patent family members on MERCK drugs in sixty-three countries and one hundred and seventy-eight supplementary protection certificates in nineteen countries.
Summary for Merck
| International Patents: | 735 |
| US Patents: | 26 |
| Tradenames: | 77 |
| Ingredients: | 70 |
| NDAs: | 92 |
| Patent Litigation for Merck: | See patent lawsuits for Merck |
| PTAB Cases with Merck as patent owner: | See PTAB cases with Merck as patent owner |
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 | BELSOMRA | suvorexant | TABLET;ORAL | 204569-001 | Aug 13, 2014 | RX | Yes | No | 10,098,892 | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Merck | DECADRON | dexamethasone sodium phosphate | CREAM;TOPICAL | 011983-002 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
| Merck | NEO-HYDELTRASOL | neomycin sulfate; prednisolone sodium phosphate | OINTMENT;OPHTHALMIC | 050378-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
| Merck Sharp Dohme | TEMODAR | temozolomide | CAPSULE;ORAL | 021029-001 | Aug 11, 1999 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
| Merck Sharp Dohme | PREVYMIS | letermovir | TABLET;ORAL | 209939-002 | Nov 8, 2017 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | |||||
| Merck Sharp Dohme | PREVYMIS | letermovir | TABLET;ORAL | 209939-002 | Nov 8, 2017 | RX | Yes | Yes | 8,513,255 | ⤷ Try a Trial | Y | Y | ⤷ 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 Sharp Dohme | TEMODAR | temozolomide | CAPSULE;ORAL | 021029-003 | Aug 11, 1999 | 5,260,291*PED | ⤷ Try a Trial |
| Merck Sharp Dohme | DUTREBIS | lamivudine; raltegravir potassium | TABLET;ORAL | 206510-001 | Feb 6, 2015 | 7,169,780*PED | ⤷ Try a Trial |
| Merck | CANCIDAS | caspofungin acetate | POWDER;INTRAVENOUS | 021227-002 | Jan 26, 2001 | 5,514,650*PED | ⤷ Try a Trial |
| Merck | PRINIVIL | lisinopril | TABLET;ORAL | 019558-003 | Dec 29, 1987 | 4,374,829*PED | ⤷ Try a Trial |
| Merck | EMEND | aprepitant | CAPSULE;ORAL | 021549-003 | Jun 30, 2006 | 5,719,147 | ⤷ Try a Trial |
| Merck | CANCIDAS | caspofungin acetate | POWDER;INTRAVENOUS | 021227-001 | Jan 26, 2001 | 5,792,746*PED | ⤷ 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 | 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 |
| ➤ 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 |
International Patents for Merck Drugs
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Portugal | 3391890 | ⤷ Try a Trial |
| New Zealand | 603799 | ⤷ Try a Trial |
| Poland | 1654263 | ⤷ Try a Trial |
| Ukraine | 119269 | ⤷ Try a Trial |
| Croatia | P20150987 | ⤷ Try a Trial |
| Austria | E518844 | ⤷ Try a Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for Merck Drugs
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2576547 | PA2021518 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: VERICIGUATAS IR JO DRUSKOS, SOLVATAI IR DRUSKU SOLVATAI ; REGISTRATION NO/DATE: EU/1/21/1561 20210716 |
| 0620232 | SPC/GB02/002 | United Kingdom | ⤷ Try a Trial | A SUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB02/002 GRANTED TO MERCK SHARP + DOHME, CORP IN RESPECT OF THE PRODUCT CASPOFUNGIN, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, ESPECIALLY CASPOFUNGIN ACETATE, WHICH WAS ADVERTISED AS COMING INTO FORCE IN JOURNAL NO 5919 DATED 30 OCTOBER 2002 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, IT WILL EXPIRE ON 24 OCTOBER 2016. |
| 1441735 | C20080001 00016 | Estonia | ⤷ Try a Trial | PRODUCT NAME: ISENTRESS; REG NO/DATE: 20.12.2007 C(2007)6801 |
| 1622880 | 2018/026 | Ireland | ⤷ Try a Trial | PRODUCT NAME: LETERMOVIR, OR ITS SALT, SOLVATE, OR SOLVATE OF ITS SALT.; REGISTRATION NO/DATE: EU/1/17/1245 20180108 |
| 2666774 | 2020024 | Norway | ⤷ Try a Trial | PRODUCT NAME: KOMBINASJON AV RELEBAKTAM EVENTUELT I FORM AV MONOHYDRAT, IMIPENEM OG CILASTATIN, EVENTUELT I FORM AV NATRIUMSALT; REG. NO/DATE: EU/1/19/1420 20200219 |
| 1441735 | C 2008 008 | Romania | ⤷ Try a Trial | PRODUCT NAME: N-(2-(4-(4-FLUOROBENZILCARBAMOIL)-5-HIDROXI-1-METIL-6-OXO-1,6-DIHIDROPIRIMIDIN-2-IL)PROPAN-2+IL)-5-METIL-1,3,4-OXADIAZOL-2-CARBOXAMIDA - RALTEGRAVIR SAU O SARE ACCEPTABILAFARMACEUTIC A ACESTUIA, INSPECIAL SAREA DE POTASIU; NATIONAL AUTHORISATION NUMBER: EMEA EU/1/07/436/001, EMEA EU/1/07/436/002; DATE OF NATIONAL AUTHORISATION: 20071220; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/07/436/001, EMEA EU/1/07/436/002; DATE OF FIRST AUTHORISATION IN EEA: 20071220 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.
Here is a list of applicants with similar names.
