IP Library › Granted Patent US 8,299,298
Granted Patent B2
US 8,299,298 · App. 13/289,048 · Granted Oct 30, 2012

Pharmaceutical-grade ferric organic compounds, uses thereof and method of making same

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Quick Facts
Patent No.
US 8,299,298
App. No.
13/289,048
Granted
Oct 30, 2012
Kind
B2
Abstract

The present invention discloses pharmaceutical-grade ferric organic compounds, including ferric citrate, which are soluble over a wider range of pH, and which have a large active surface area. A manufacturing and quality control process for making a pharmaceutical-grade ferric citrate that consistently complies with the established Manufacture Release Specification is also disclosed. The pharmaceutical-grade ferric organic compounds are suitable for treating disorders characterized by elevated serum phosphate levels.

Claims (9)

1. A pharmaceutical composition comprising ferric citrate having a BET active surface area of at least 16 sq. m/g and a pharmaceutically suitable carrier, wherein the ferric citrate is present in an amount effective to reduce serum phosphate levels.

2. The pharmaceutical composition of claim 1 , wherein the ferric citrate has an intrinsic dissolution rate of 1.88-4.0 mg/cm 2 /min.

3. The pharmaceutical composition of claim 1 , wherein the effective amount of ferric citrate is from 2 grams per day-30 grams per day.

4. The pharmaceutical composition of claim 1 , wherein the effective amount of ferric citrate is from 4 grams per day-15 grams per day.

5. The pharmaceutical composition of claim 1 , wherein the effective amount of ferric citrate is from 2 grams per day-12 grams per day.

6. The pharmaceutical composition of claim 1 , wherein the effective amount of ferric citrate is selected from 2 grams per day, 4 grams per day and 6 grams per day.

7. The pharmaceutical composition of claim 1 , wherein the effective amount of ferric citrate is 1 gram per day.

8. The pharmaceutical composition of claim 1 , wherein the effective amount of ferric citrate is 500 mg per unit dosage form.

9. A pharmaceutical composition comprising 500 mg of ferric citrate having a BET active surface area of at least 16 sq. m/g, and a pharmaceutically suitable carrier, wherein the pharmaceutical composition is in a capsule dosage form.

Assignments (19)
TERMINATION AND RELEASE OF SECURITY INTEREST IN PATENTS Recorded Jun 25, 2024
From: BIOPHARMA CREDIT PLC
To: AKEBIA THERAPEUTICS, INC.; KERYX BIOPHARMACEUTICALS, INC.
Reel/Frame 067839/0134 →
TERMINATION AND RELEASE OF SECURITY INTEREST IN PATENTS Recorded Jan 29, 2024
From: BIOPHARMA CREDIT PLC
To: AKEBIA THERAPEUTICS, INC.; KERYX BIOPHARMACEUTICALS, INC.
Reel/Frame 066377/0741 →
FIFTEENTH AMENDED AND RESTATED INTELLECTUAL PROPERTY SECURITY AGREEMENT Recorded Jan 4, 2024
From: AKEBIA THERAPEUTICS, INC.; KERYX BIOPHARMACEUTICALS, INC.
To: BIOPHARMA CREDIT PLC
Reel/Frame 066205/0143 →
THIRTEENTH AMENDED AND RESTATED INTELLECTUAL PROPERTY SECURITY AGREEMENT Recorded Mar 29, 2023
From: AKEBIA THERAPEUTICS, INC.; KERYX BIOPHARMACEUTICALS, INC.
To: BIOPHARMA CREDIT PLC
Reel/Frame 063189/0065 →
TWELFTH AMENDED AND RESTATED INTELLECTUAL PROPERTY SECURITY AGREEMENT Recorded Nov 29, 2022
From: AKEBIA THERAPEUTICS, INC.; KERYX BIOPHARMACEUTICALS, INC.
To: BIOPHARMA CREDIT PLC
Reel/Frame 062012/0561 →
ELEVENTH AMENDED AND RESTATED INTELLECTUAL PROPERTY SECURITY AGREEMENT Recorded Aug 22, 2022
From: AKEBIA THERAPEUTICS, INC.; KERYX BIOPHARMACEUTICALS, INC.
To: BIOPHARMA CREDIT PLC
Reel/Frame 061297/0238 →
TENTH AMENDED AND RESTATED INTELLECTUAL PROPERTY SECURITY AGREEMENT Recorded Jun 16, 2022
From: AKEBIA THERAPEUTICS, INC.; KERYX BIOPHARMACEUTICALS, INC.
To: BIOPHARMA CREDIT PLC
Reel/Frame 060529/0168 →
SECURITY INTEREST Recorded Dec 15, 2021
From: AKEBIA THERAPEUTICS, INC.; KERYX BIOPHARMACEUTICALS, INC.
To: BIOPHARMA CREDIT PLC
Reel/Frame 058399/0055 →
SEVENTH AMENDED AND RESTATED INTELLECTUAL PROPERTY SECURITY AGREEMENT Recorded Sep 12, 2021
From: AKEBIA THERAPEUTICS, INC.; KERYX BIOPHARMACEUTICALS, INC.
To: BIOPHARMA CREDIT PLC
Reel/Frame 057474/0770 →
SIXTH AMENDED AND RESTATED INTELLECTUAL PROPERTY SECURITY AGREEMENT Recorded Jun 11, 2021
From: AKEBIA THERAPEUTICS, INC.; KERYX BIOPHARMACEUTICALS, INC.
To: BIOPHARMA CREDIT PLC
Reel/Frame 056544/0468 →
FIFTH AMENDED AND RESTATED INTELLECTUAL PROPERTY SECURITY AGREEMENT Recorded Mar 30, 2021
From: AKEBIA THERAPEUTICS, INC.; KERYX BIOPHARMACEUTICALS, INC.
To: BIOPHARMA CREDIT PLC
Reel/Frame 055776/0491 →
FOURTH AMENDED AND RESTATED INTELLECTUAL PROPERTY SECURITY AGREEMENT Recorded Dec 17, 2020
From: AKEBIA THERAPEUTICS, INC.; KERYX BIOPHARMACEUTICALS, INC.
To: BIOPHARMA CREDIT PLC
Reel/Frame 054793/0455 →
THIRD AMENDED AND RESTATED INTELLECTUAL PROPERTY SECURITY AGREEMENT Recorded Sep 10, 2020
From: AKEBIA THERAPEUTICS, INC.; KERYX BIOPHARMACEUTICALS, INC.
To: BIOPHARMA CREDIT PLC
Reel/Frame 054173/0451 →
SECOND AMENDED AND RESTATED INTELLECTUAL PROPERTY SECURITY AGREEMENT Recorded Sep 2, 2020
From: AKEBIA THERAPEUTICS, INC.; KERYX BIOPHARMACEUTICALS, INC.
To: BIOPHARMA CREDIT PLC
Reel/Frame 053671/0221 →
SECURITY INTEREST Recorded Apr 2, 2020
From: AKEBIA THERAPEUTICS, INC.; KERYX BIOPHARMACEUTICALS, INC.
To: BIOPHARMA CREDIT PLC
Reel/Frame 052295/0662 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 30, 2015
From: KWOK, DAVID W.K.; STOYNOV, NIKOLAY MINTCHEV
To: PANION & BF BIOTECH INC.
Reel/Frame 035540/0527 →
CORRECTIVE ASSIGNMENT TO CORRECT THE CONVEYANCE TYPE PREVIOUSLY RECORDED ON REEL 029417 FRAME 0373. ASSIGNOR(S) HEREBY CONFIRMS THE NUNC PRO TUNC ASSIGNMENT WITH THE EFFECTIVE DATE OF AUGUST 18, 2006. Recorded Dec 10, 2012
From: GLOBOASIA, LLC
To: PANION & BF BIOTECH, INC.
Reel/Frame 029436/0054 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 6, 2012
From: GLOBOASIA, LLC
To: PANION & BF BIOTECH, INC.
Reel/Frame 029417/0373 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 6, 2012
From: CHAN, KEITH; TOWN, WINSTON
To: GLOBOASIA, LLC
Reel/Frame 029417/0254 →