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-three US patents protecting MALLINCKRODT drugs.
There are one hundred and sixty-four patent family members on MALLINCKRODT drugs in twenty-three countries and seventy-eight supplementary protection certificates in eight countries.
Summary for MALLINCKRODT
| International Patents: | 164 |
| US Patents: | 33 |
| 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 | ⤷ Sign Up | ⤷ Sign Up | |||||
| Mallinckrodt | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | acetaminophen; butalbital; caffeine | CAPSULE;ORAL | 088758-001 | Mar 27, 1985 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | |||||
| Mallinckrodt | ANEXSIA 7.5/650 | acetaminophen; hydrocodone bitartrate | TABLET;ORAL | 089725-001 | Sep 30, 1987 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | |||||
| Mallinckrodt Hosp | INOMAX | nitric oxide | GAS;INHALATION | 020845-003 | Dec 23, 1999 | AA | RX | Yes | Yes | 9,265,911*PED | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Mallinckrodt | ANEXSIA | acetaminophen; hydrocodone bitartrate | TABLET;ORAL | 040468-001 | Oct 31, 2002 | DISCN | No | No | ⤷ 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 | INOMAX | nitric oxide | GAS;INHALATION | 020845-002 | Dec 23, 1999 | 5,873,359*PED | ⤷ Sign Up |
| Mallinckrodt Hosp | INOMAX | nitric oxide | GAS;INHALATION | 020845-002 | Dec 23, 1999 | 6,125,846*PED | ⤷ Sign Up |
| Mallinckrodt Inc | XARTEMIS XR | acetaminophen; oxycodone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 204031-001 | Mar 11, 2014 | 6,488,962 | ⤷ Sign Up |
| Mallinckrodt Hosp | INOMAX | nitric oxide | GAS;INHALATION | 020845-002 | Dec 23, 1999 | 5,485,827*PED | ⤷ Sign Up |
| Mallinckrodt Hosp | UVADEX | methoxsalen | INJECTABLE;INJECTION | 020969-001 | Feb 25, 1999 | 4,845,075 | ⤷ 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 | Injection | 1000 mg/100 mL (10 mg/mL) | ➤ Subscribe | 2011-04-07 |
| ➤ 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 |
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 | 18C1043 | France | ⤷ Sign Up | PRODUCT NAME: UNE COMBINAISON COMPRENANT DU DOLUTEGRAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI,EN PARTICULIER LE SEL DE SODIUM DU DOLUTEGRAVIR,ET DE LA RILPIVIRINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI,EN PARTICULIER LE CHLORHYDRATE DE RILPIVIRINE; REGISTRATION NO/DATE: EU/1/18/1282 20180518 |
| 0788511 | SPC/GB08/036 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: MICAFUNGIN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF IN PARTICULAR MICAFUNGIN SODIUM; REGISTERED: UK EU/1/08/448/001 20080425; UK EU/1/08/448/002 20080425 |
| 1718641 | 2012/008 | Ireland | ⤷ Sign Up | PRODUCT NAME: AZILSARTAN MEDOXOMIL AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, INCLUDING THE POTASSIUM SALT; REGISTRATION NO/DATE: EU/1/11/734/001-011 EU/1/11/735/001-011 20111209 |
| 3141251 | SPC/GB20/075 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: A MEDICINAL PRODUCT CONSISTING OF A COMBINATION OF A FIRST DOSE PHARMACEUTICAL COMPOSITION AND A SECOND DOSE PHARMACEUTICAL COMPOSITION, THE FIRST DOSE PHARMACEUTICAL COMPOSITION CONSISTING OF THE ACTIVE INGREDIENTS: POLYETHYLENE GLYCOL 3350, SODIUM SULPH; REGISTERED: IS IS/1/17/063/01 20171016; UK PL 20011/0040 20171016 |
| 1718641 | SPC/GB12/028 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: AZILSARTAN MEDOXOMIL AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, INCLUDING THE POTASSIUM SALT; REGISTERED: UK EU/1/11/734/001-011 20111209 |
| >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.
