IP Library Granted Patent US 9,610,265
Granted Patent B2
US 9,610,265 · App. 15/184,056 · Granted Apr 4, 2017

Reduced dose intravenous acetaminophen

Inventors: Mike Allan Royal (San Diego, CA); James Bradley Breitmeyer (Rancho Santa Fe, CA)
Assignee: MALLINCKRODT IP
A61K31/167A61K9/0019A61K31/485A61K47/02A61K47/18A61K47/183
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Quick Facts
Patent No.
US 9,610,265
App. No.
15/184,056
Granted
Apr 4, 2017
Kind
B2
Abstract

Described herein are compositions and methods for intravenous administration of acetaminophen at a single dose level of less than about 1000 mg for the treatment or prevention of pain (e.g., postoperative pain) and/or fever.

Claims (22)

1. A method of treating pain in a human subject weighing at least 50 kg comprising:

co-administering to the subject a therapeutically effective amount of a first pharmaceutical composition comprising about 500 mg to about 750 mg of acetaminophen and a therapeutically effective amount a second pharmaceutical composition comprising an opioid analgesic;

wherein the first pharmaceutical composition is administered to the subject intravenously.

2. The method of claim 1 wherein the administration of the first pharmaceutical composition to the subject is repeated at least once every four hours for a twenty-four hour period.

3. The method of claim 1 , wherein subject is administered less than 4 grams of acetaminophen over a twenty-four hour period.

4. The method of claim 3 , wherein the first pharmaceutical composition is administered to the subject at least six times in a period of 24 hours.

5. The method of claim 3 , wherein the first pharmaceutical composition is administered to the subject at least seven times in a period of 24 hours.

6. The method of claim 1 , wherein the first pharmaceutical composition comprises about 600 mg to about 700 mg of acetaminophen.

7. The method of claim 1 , wherein the first pharmaceutical composition comprises about 650 mg of acetaminophen.

8. The method of claim 1 , wherein the opioid analgesic is selected from the group consisting of allylprodine, alphamethylfentanyl, alfentanil, bezitramide, buprenorphine, butorphanol, carfentanyl, codeine, dextropropoxyphene, dextromoramide, dezocine, diacetylmorphine, dihydrocodeine, dipapanone, dismorphine, dihydrocodeine, etorphine, fentanyl, hydrocodone, hydromorphone, ketobemidone, lefetamine, levorphanol, levo-alphacetylmethadol, levomethorphan, meptazinol, methadone, morphine, nalbuphine, nicomorphine, ohmefentanyl, opium, oripavine, oxycodone, oxymorphone, methadone, phenethylphenylacetoxypiperidine (PEPAP), pentazocine, pethidine, phenazocine, piritamide, prodine, propoxyphene napsylate, remifentanil, sufentanil, tilidine, thebaine, tramadol, and tapentadol.

9. The method of claim 8 , wherein the opioid analgesic is selected from the group consisting of codeine, dihydrocodeine, hydrocodone, morphine, oxycodone, pentazocine, and tramadol.

10. The method of claim 8 , wherein the opioid analgesic is morphine.

11. The method of claim 1 , wherein the second pharmaceutical composition is administered to the subject orally, intravenously, recitally, or parenterally.

12. The method of claim 1 , wherein the second pharmaceutical composition is administered as a single dose or in multiple doses.

13. The method of claim 1 , wherein the first and second pharmaceutical compositions are administered simultaneously.

14. The method of claim 13 , wherein the first and second pharmaceutical compositions are administered as a combined intravenous dosage form.

15. The method of claim 1 , wherein the first and second pharmaceutical compositions are administered sequentially.

16. The method of claim 15 , wherein the first pharmaceutical composition is administered prior to the second pharmaceutical composition or wherein the second pharmaceutical composition is administered prior to the first pharmaceutical composition.

17. The method of claim 15 , wherein the timing between the administration of the first and second pharmaceutical compositions is from about 1 minute to less than about 12 hours.

18. The method of claim 15 , wherein the timing between the administration of the first and second pharmaceutical compositions is from about 1 minute to less than about 6 hours.

19. The method of claim 15 , wherein the timing between the administration of the first and second pharmaceutical compositions is from about 1 minute to less than about 3 hours.

20. The method of claim 15 , wherein the timing between the administration of the first and second pharmaceutical compositions is from about 1 minute to less than about 1 hour.

Assignments (19)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 10, 2026
From: MALLINCKRODT HOSPITAL PRODUCTS IP UNLIMITED COMPANY
To: MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED COMPANY
Reel/Frame 075393/0921 →
CORRECTIVE ASSIGNMENT TO CORRECT THE INCLUSION OF US PATENT 10828415 AND REMOVE IT FROM THE LISTING PREVIOUSLY RECORDED ON REEL 73375 FRAME 395. ASSIGNOR(S) HEREBY CONFIRMS THE SECURITY INTEREST. Recorded Mar 6, 2026
From: MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED
To: GOLDMAN SACHS BANK USA, AS ADMINISTRATIVE AGENT
Reel/Frame 075021/0263 →
CORRECTIVE ASSIGNMENT TO CORRECT THE INCLUSION OF US PATENT 10828415 AND REMOVE IT FROM THE LISTING PREVIOUSLY RECORDED ON REEL 72331 FRAME 1. ASSIGNOR(S) HEREBY CONFIRMS THE SECURITY INTEREST. Recorded Mar 6, 2026
From: MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED
To: COMPUTERSHARE TRUST COMPANY, NATIONAL ASSOCIATION
Reel/Frame 075021/0204 →
SECURITY INTEREST Recorded Oct 28, 2025
From: MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED
To: GOLDMAN SACHS BANK USA, AS ADMINISTRATIVE AGENT
Reel/Frame 073375/0395 →
RELEASE OF SECURITY INTEREST Recorded Aug 14, 2025
From: ACQUIOM AGENCY SERVICES LLC
To: SPECGX LLC; MALLINCKRODT ENTERPRISES LLC; MALLINCKRODT LLC; MALLINCKRODT PHARMA IP TRADING UNLIMITED COMPANY; MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED; OCERA THERAPEUTICS LLC; STRATATECH CORPORATION; SUCAMPO PHARMA AMERICAS LLC; VTESSE LLC
Reel/Frame 072324/0740 →
SECURITY INTEREST Recorded Aug 1, 2025
From: MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED
To: COMPUTERSHARE TRUST COMPANY, NATIONAL ASSOCIATION
Reel/Frame 072331/0001 →
RELEASE OF PATENT SECURITY INTERESTS RECORDED AT REEL 043596, FRAME 0107 Recorded Nov 16, 2023
From: DEUTSCHE BANK AG NEW YORK BRANCH, AS COLLATERAL AGENT
To: MALLINCKRODT INTERNATIONAL FINANCE S.A.; MALLINCKRODT CB LLC; MALLINCKRODT FINANCE GMBH; MALLINCKRODT US HOLDINGS LLC (F/K/A MALLINCKRODT US HOLDINGS INC.); MALLINCKRODT CARRIBEAN, INC.; MALLINCKRODT US POOL LLC; MNK 2011 LLC (F/K/A MALLINCKRODT INC.); LUDLOW LLC (F/K/A LUDLOW CORPORATION); CNS THERAPEUTICS, INC.; MALLINCKRODT ENTERPRISES HOLDINGS LLC (F/K/A MALLINCKRODT ENTERPRISES HOLDINGS, INC.); MALLINCKRODT ENTERPRISES LLC; MALLINCKRODT LLC; LAFAYETTE PHARMACEUTICALS LLC; LIEBEL-FLARSHEIM COMPANY LLC; MALLINCKRODT BRAND PHARMACEUTICALS LLC (F/K/A MALLINCKRODT BRAND PHARMACEUTICALS, INC.); MALLINCKRODT VETERINARY, INC.; MALLINCKRODT US HOLDINGS LLC; IMC EXPLORATION COMPANY; MEH, INC.; MALLINCKRODT HOSPITAL PRODUCTS IP UNLIMITED COMPANY (F/K/A MALLINCKRODT HOSPITAL PRODUCTS IP LIMITED); MALLINCKRODT ARD IP UNLIMITED COMPANY (F/K/A MALLINCKRODT ARD IP LIMITED); OCERA THERAPEUTICS LLC (F/K/A OCERA THERAPEUTICS, INC.); SPECGX LLC; STRATATECH CORPORATION; SUCAMPO PHARMA AMERICAS LLC; VTESSE LLC (F/K/A VTESSE INC.); MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED; MALLINCKRODT PHARMA IP TRADING UNLIMITED COMPANY (F/K/A MALLINCKRODT PHARMA IP TRADING D.A.C.); INFACARE PHARMACEUTICAL CORPORATION; ST SHARED SERVICES LLC; THERAKOS, INC.; IKARIA THERAPEUTICS LLC; INO THERAPEUTICS LLC
Reel/Frame 065610/0276 →
RELEASE OF PATENT SECURITY INTERESTS RECORDED AT REEL 060434, FRAME 0536 Recorded Nov 16, 2023
From: DEUTSCHE BANK AG NEW YORK BRANCH, AS COLLATERAL AGENT
To: MALLINCKRODT ENTERPRISES LLC; MALLINCKRODT LLC; SPECGX LLC; OCERA THERAPEUTICS, INC.; STRATATECH CORPORATION; VTESSE LLC; MALLINCKRODT PHARMA IP TRADING UNLIMITED COMPANY; MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED; SUCAMPO PHARMA AMERICAS LLC
Reel/Frame 065601/0347 →
RELEASE OF SECURITY INTERESTS IN PATENTS AT REEL 060389/FRAME 0913 Recorded Nov 15, 2023
From: WILMINGTON SAVINGS FUND SOCIETY, FSB, AS SECOND LIEN COLLATERAL AGENT
To: OCERA THERAPEUTICS LLC (F/K/A OCERA THERAPEUTICS, INC.); MALLINCKRODT LLC; MALLINCKRODT ENTERPRISES LLC; MALLINCKRODT PHARMA IP TRADING UNLIMITED COMPANY; SPECGX LLC; STRATATECH CORPORATION; SUCAMPO PHARMA AMERICAS LLC; VTESSE LLC; MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED
Reel/Frame 065583/0465 →
SECURITY INTEREST Recorded Nov 15, 2023
From: MALLINCKRODT ENTERPRISES LLC; MALLINCKRODT LLC; MALLINCKRODT PHARMA IP TRADING UNLIMITED COMPANY; MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED; OCERA THERAPEUTICS LLC; SPECGX LLC; STRATATECH CORPORATION; SUCAMPO PHARMA AMERICAS LLC; VTESSE LLC
To: ACQUIOM AGENCY SERVICES LLC
Reel/Frame 065595/0376 →
NOTICE OF GRANT OF SECURITY INTEREST IN INTELLECTUAL PROPERTY Recorded Jun 22, 2022
From: MALLINCKRODT ENTERPRISES LLC; MALLINCKRODT LLC; SPECGX LLC; OCERA THERAPEUTICS, INC.; STRATATECH CORPORATION; SUCAMPO PHARMA AMERICAS LLC; VTESSE LLC; MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED; MALLINCKRODT PHARMA IP TRADING UNLIMITED COMPANY
To: DEUTSCHE BANK AG NEW YORK BRANCH
Reel/Frame 060434/0536 →
RELEASE OF SECURITY INTEREST Recorded Jun 17, 2022
From: WILMINGTON SAVINGS FUND SOCIETY, FSB, AS SECOND LIEN COLLATERAL AGENT
To: OCERA THERAPEUTICS, INC.; MALLINCKRODT LLC; MALLINCKRODT ARD IP UNLIMITED COMPANY (F/K/A MALLINCKRODT ARD IP LIMITED); MALLINCKRODT HOSPITAL PRODUCTS IP UNLIMITED COMPANY (F/K/A MALLINCKRODT HOSPITAL PRODUCTS IP LIMITED); MALLINCKRODT PHARMA IP TRADING UNLIMITED COMPANY (F/K/A MALLINCKRODT PHARMA IP TRADING DESIGNATED ACTIVITY COMPANY); SPECGX LLC; STRATATECH CORPORATION; VTESSE LLC (F/K/A VTESSE INC.)
Reel/Frame 060389/0839 →
SECURITY INTEREST Recorded Jun 17, 2022
From: MALLINCKRODT ENTERPRISES LLC; MALLINCKRODT LLC; SPECGX LLC; OCERA THERAPEUTICS, INC.; STRATATECH CORPORATION; SUCAMPO PHARMA AMERICAS LLC; VTESSE LLC; MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED
To: WILMINGTON SAVINGS FUND SOCIETY, FSB, AS SECOND LIEN COLLATERAL AGENT
Reel/Frame 060389/0913 →
SECURITY INTEREST Recorded Dec 10, 2019
From: MALLINCKRODT ARD IP LIMITED; MALLINCKRODT HOSPITAL PRODUCTS IP LIMITED; SPECGX LLC; OCERA THERAPEUTICS, INC.; MALLINCKRODT PHARMA IP TRADING DESIGNATED ACTIVITY COMPANY; STRATATECH CORPORATION; VTESSE INC.; MALLINCKRODT LLC
To: WILMINGTON SAVINGS FUND SOCIETY, FSB, AS SECOND LIEN COLLATERAL AGENT
Reel/Frame 051256/0829 →
CHANGE OF NAME Recorded Nov 2, 2018
From: MALLINCKRODT IP
To: MALLINCKRODT IP UNLIMITED COMPANY
Reel/Frame 047404/0945 →
NUNC PRO TUNC ASSIGNMENT Recorded Nov 2, 2018
From: MALLINCKRODT IP UNLIMITED COMPANY
To: MALLINCKRODT HOSPITAL PRODUCTS IP LIMITED
Reel/Frame 047394/0214 →
NOTICE OF GRANT OF SECURITY INTEREST IN PATENTS Recorded Aug 18, 2017
From: MALLINCKRODT IP UNLIMITED COMPANY
To: DEUTSCHE BANK AG NEW YORK BRANCH, AS COLLATERAL AGENT
Reel/Frame 043596/0107 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 1, 2016
From: CADENCE PHARMACEUTICALS, INC.
To: MALLINCKRODT IP
Reel/Frame 040185/0447 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 1, 2016
From: ROYAL, MIKE ALLAN; BREITMEYER, JAMES BRADLEY
To: CADENCE PHARMACEUTICALS, INC.
Reel/Frame 040185/0345 →
Continuity (3)
Continuation 12270796 · Nov 13, 2008
Provisional Application 60987761 · Nov 13, 2007
Related Publication 20160287538A1 · Oct 6, 2016