MALLINCKRODT Company Profile
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What is the competitive landscape for MALLINCKRODT, and what generic alternatives to MALLINCKRODT drugs are available?
MALLINCKRODT has forty-six approved drugs.
There are thirty-five US patents protecting MALLINCKRODT drugs.
There are one hundred and sixty-five patent family members on MALLINCKRODT drugs in twenty-three countries and seventy-eight supplementary protection certificates in eight countries.
Summary for MALLINCKRODT
| International Patents: | 165 |
| US Patents: | 35 |
| Tradenames: | 40 |
| Ingredients: | 29 |
| NDAs: | 46 |
| Patent Litigation for MALLINCKRODT: | See patent lawsuits for MALLINCKRODT |
| PTAB Cases with MALLINCKRODT as patent owner: | See PTAB cases with MALLINCKRODT as patent owner |
Drugs and US Patents for MALLINCKRODT
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mallinckrodt Ard | ACTHAR GEL (AUTOINJECTOR) | corticotropin | INJECTABLE;INJECTION | 008372-004 | Feb 29, 2024 | RX | Yes | Yes | 11,752,199 | ⤷ Sign Up | ⤷ Sign Up | ||||
| Mallinckrodt Inc | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | acetaminophen; hydrocodone bitartrate | SOLUTION;ORAL | 040508-001 | Aug 29, 2003 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | |||||
| Mallinckrodt | SODIUM PHOSPHATE P 32 | sodium phosphate p-32 | SOLUTION;INJECTION, ORAL | 011777-002 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | |||||
| Mallinckrodt | MD-76 | diatrizoate meglumine; diatrizoate sodium | INJECTABLE;INJECTION | 087073-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | |||||
| Mallinckrodt Inc | BAROS | sodium bicarbonate; tartaric acid | GRANULE, EFFERVESCENT;ORAL | 018509-001 | Aug 7, 1985 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | |||||
| Mallinckrodt Ard | ACTHAR GEL | corticotropin | INJECTABLE;INJECTION | 008372-006 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | |||||
| Mallinckrodt Inc | XARTEMIS XR | acetaminophen; oxycodone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 204031-001 | Mar 11, 2014 | DISCN | Yes | No | 7,976,870 | ⤷ Sign Up | ⤷ Sign Up | ||||
| >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 MALLINCKRODT
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Mallinckrodt Hosp | OFIRMEV | acetaminophen | SOLUTION;INTRAVENOUS | 022450-001 | Nov 2, 2010 | 6,028,222*PED | ⤷ Sign Up |
| Mallinckrodt Hosp | OFIRMEV | acetaminophen | SOLUTION;INTRAVENOUS | 022450-001 | Nov 2, 2010 | 6,992,218*PED | ⤷ Sign Up |
| Mallinckrodt Hosp | INOMAX | nitric oxide | GAS;INHALATION | 020845-003 | Dec 23, 1999 | 6,125,846*PED | ⤷ Sign Up |
| Mallinckrodt Hosp | INOMAX | nitric oxide | GAS;INHALATION | 020845-003 | Dec 23, 1999 | 5,485,827*PED | ⤷ Sign Up |
| Mallinckrodt Hosp | INOMAX | nitric oxide | GAS;INHALATION | 020845-002 | Dec 23, 1999 | 5,752,504*PED | ⤷ Sign Up |
| Mallinckrodt Hosp | INOMAX | nitric oxide | GAS;INHALATION | 020845-003 | Dec 23, 1999 | 5,752,504*PED | ⤷ Sign Up |
| Mallinckrodt Hosp | INOMAX | nitric oxide | GAS;INHALATION | 020845-002 | Dec 23, 1999 | 5,485,827*PED | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Paragraph IV (Patent) Challenges for MALLINCKRODT drugs
| Drugname | Dosage | Strength | Tradename | Submissiondate |
|---|---|---|---|---|
| ➤ Subscribe | for Inhalation | 100 ppm and 800 ppm | ➤ Subscribe | 2014-05-20 |
| ➤ Subscribe | Extended-release Tablets | 7.5 mg/325 mg | ➤ Subscribe | 2014-04-03 |
| ➤ Subscribe | Injection | 1000 mg/100 mL (10 mg/mL) | ➤ Subscribe | 2011-04-07 |
Premature patent expirations for MALLINCKRODT
International Patents for MALLINCKRODT Drugs
Supplementary Protection Certificates for MALLINCKRODT Drugs
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2932970 | 1890039-9 | Sweden | ⤷ Sign Up | PRODUCT NAME: DOLUTEGRAVIR SODIUM + RILPIVIRINE HYDROCHLORIDE; REG. NO/DATE: EU/1/18/1282 20180518 |
| 1259550 | 08C0052 | France | ⤷ Sign Up | PRODUCT NAME: SUGAMMADEX SODIUM; REGISTRATION NO/DATE: EU/1/08/466/001-002 20080725 |
| 0579826 | SPC/GB02/042 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: ERTAPENEM ((1R,5S,6S,8R,2'S,4'S)-2-(2-(3-CARBOXYPHENYLCARBAMOYL)PYRROLIDIN-4-YLTHIO)-6-(1-HYDROXYETHYL)-1-METHYLCARBAPENEM-3-CARBOXYLIC ACID), A PHARMACEUTICALLY ACCEPTABLE SALT OR IN VIVO HYDROLYSABLE ESTER THEREOF, ESPECIALLY AS THE MONOSODIUM SALT ERTA; REGISTERED: UK EU/1/02/216/001 20020422 |
| 2563920 | CA 2019 00001 | Denmark | ⤷ Sign Up | PRODUCT NAME: A COMPOUND COMPRISING A MODIFIED OLIGONUCLEOTIDE HAVING A NUCLEOBASE SEQUENCE CONSISTING OF 20 LINKED NUCLEOSIDES ACCORDING TO EP B1 2563920 CLAIM 1 (SEQ ID NO: 80), ...SPECIFICALLY INOTERSEN; AND ITS DERIVATIVES, INCLUDING SODIUM SALTS ...; REG. NO/DATE: EU/1/18/1296 20180710 |
| 2380576 | 20C1048 | France | ⤷ Sign Up | PRODUCT NAME: SEL DE SODIUM DE L'ACIDE DESOXYCHOLIQUE; NAT. REGISTRATION NO/DATE: NL46299 20180810; FIRST REGISTRATION: IS - IS/1/16/071/01 20160729 |
| 0290047 | 97C0108 | Belgium | ⤷ Sign Up | PRODUCT NAME: MANGAFODIPIR TRISODIUM (ANHYDROUS) CORRESP. MANGAFODIPIR; REGISTRATION NO/DATE: EU/1/97/040/001 19970522 |
| 2203431 | 15C0013 | France | ⤷ Sign Up | PRODUCT NAME: DASABUVIR OU UN SEL DE CELUI-CI, NOTAMMENT LE SEL DE SODIUM; REGISTRATION NO/DATE: EU/1/14/983 20150119 |
| >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.
