US Pat. No. 9,375,478

VASOPRESSIN FORMULATIONS FOR USE IN TREATMENT OF HYPOTENSION

PAR PHARMACEUTICAL, INC.,...

1. A method of increasing blood pressure in a human in need thereof, the method comprising administering to the human a unit
dosage form, wherein the unit dosage form consists essentially of:
a) from about 0.01 mg/mL to about 0.07 mg/mL of vasopressin or a pharmaceutically-acceptable salt thereof;
b) 10 mM acetate buffer; and
c) water,wherein:
the unit dosage form has a pH of 3.8;
the administration provides to the human from about 0.01 units of vasopressin or the pharmaceutically-acceptable salt thereof
per minute to about 0.1 units of vasopressin or the pharmaceutically-acceptable salt thereof per minute; and

the human is hypotensive.
US Pat. No. 9,186,374

VITAMIN B12 NASAL SPRAY AND METHOD OF USE

Par Pharmaceutical, Inc.,...

1. A kit comprising:
A) a composition for nasal administration of a cobalamin compound, the composition comprising an aqueous solution containing
about 0.02% w/w to about 1% w/w of a cobalamin compound and a pharmaceutically acceptable buffer, wherein the composition
is sterile, wherein the composition is free of preservatives, wherein the composition has a pH of about 4 to about 6.5, and
wherein the cobalamin compound is cyanocobalamin or hydroxocobalamin; and

B) a container equipped with a pump adapted to deliver the composition into a patient's nostril, wherein the container is
configured such that the dose of the cobalamin compound delivered with each administration is from about 5 ?g to about 45
?g.

US Pat. No. 9,295,657

EPINEPHRINE FORMULATIONS

Par Pharmaceutical, Inc.,...

1. A method of treating a condition comprising administering to a patient in need thereof a composition comprising:
in the range of about 0.5 to 1.5 mg/mL of epinephrine and/or salts thereof,
in the range of about 6 to 8 mg/mL of a tonicity regulating agent,
in the range of about 2.8 to 3.8 mg/mL of a pH raising agent,
in the range of about 0.1 to 1.1 mg/mL of an antioxidant,
in the range of about 0.001 to 0.010 mL/mL of a pH lowering agent, and
in the range of about 0.01 to 0.4 mg/mL of a transition metal complexing agent;
wherein the antioxidant comprises sodium bisulfite and/or sodium metabisulfite, and
wherein the condition is selected from the group consisting of anaphylaxis, bronchospasm, sensitivity reactions, cardiac arrhythmias,
GI and renal hemorrhage, superficial bleeding, premature labor, hypoglycemia, and cardiogenic, hemorrhagic, and traumatic
shock.

US Pat. No. 9,119,876

EPINEPHRINE FORMULATIONS

PAR PHARMACEUTICAL, INC.,...

1. A composition comprising:
in the range of about 0.5 to 1.5 mg/mL of epinephrine and/or salts thereof,
in the range of about 6 to 8 mg/mL of a tonicity regulating agent,
in the range of about 2.8 to 3.8 mg/mL of a pH raising agent,
in the range of about 0.1 to 1.1 mg/mL of an antioxidant,
in the range of about 0.001 to 0.010 mL/mL of a pH lowering agent, and
in the range of about 0.01 to 0.4 mg/mL of a transition metal complexing agent,
wherein the antioxidant comprises sodium bisulfite and/or sodium metabisulfite.
US Pat. No. 9,687,526

VASOPRESSIN FORMULATIONS FOR USE IN TREATMENT OF HYPOTENSION

PAR PHARMACEUTICAL, INC.,...

1. A method of increasing blood pressure in a human in need thereof, the method comprising:
a) providing a pharmaceutical composition for intravenous administration comprising: i) from about 0.01 mg/mL to about 0.07
mg/mL of vasopressin or a pharmaceutically-acceptable salt thereof; ii) acetic acid; and iii) water,

wherein the pharmaceutical composition has a pH of 3.8;
b) storing the pharmaceutical composition at 2-8° C. for at least 4 weeks; and
c) intravenously administering the pharmaceutical composition to the human,
wherein the administration provides to the human from about 0.01 units of vasopressin or the pharmaceutically-acceptable salt
thereof per minute to about 0.1 units of vasopressin or the pharmaceutically-acceptable salt thereof per minute,

wherein the human is hypotensive,
wherein the pharmaceutical composition exhibits less than about 5% degradation after storage at 2-8° C. for about four weeks.
US Pat. No. 9,981,006

VASOPRESSIN FORMULATIONS FOR USE IN TREATMENT OF HYPOTENSION

PAR PHARMACEUTICAL, INC.,...

1. A method of increasing blood pressure in a human in need thereof, the method comprising:providing a pharmaceutical composition that comprises, in a unit dosage form i) from about 0.1 ?g/mL to about 2 ?g/mL of vasopressin or a pharmaceutically-acceptable salt thereof; ii) dextrose; iii) from about 1 mM to about 10 mM acetate buffer; and iv) SEQ ID NO.: 2, wherein the unit dosage form has a pH of 3.6 to 3.9;
storing the unit dosage form for at least about 24 hours at a concentration from about 0.1 ?g/ml to about 2 ?g/mI vasopressin or a pharmaceutically-acceptable salt thereof; and
after the storing, intravenously administering the unit dosage form to the human;
wherein:
the administration provides to the human from about 0.01 units of vasopressin or the pharmaceutically-acceptable salt thereof per minute to about 0.1 units of vasopressin or the pharmaceutically-acceptable salt thereof per minute,
wherein the vasopressin or the pharmaceutically-acceptable salt thereof and SEQ ID NO.:2 are present in the unit dosage form at a ratio of about 1000: about 1 to about 30: about 1,
wherein the unit dosage form that is administered to the human comprises from about 0.1?g/mL to about 2 ?g/mL of vasopressin or the pharmaceutically-acceptable salt thereof; and
the human is hypotensive.
US Pat. No. 9,744,239

VASOPRESSIN FORMULATIONS FOR USE IN TREATMENT OF HYPOTENSION

PAR PHARMACEUTICAL, INC.,...

1. A method of increasing blood pressure in a human in need thereof, the method comprising:
a) providing a pharmaceutical composition for intravenous administration consisting of, in a unit dosage form: i) from about
0.01 mg/mL to about 0.07 mg/mL of vasopressin or a pharmaceutically-acceptable salt thereof; ii) optionally chlorobutanol;
iii) acetic acid, acetate, or a combination thereof; iv) 0-2% vasopressin degradation products; and v) water;

b) diluting the unit dosage form in a diluent to provide a concentration from about 0.1 units/mL to about 1 unit/mL of vasopressin
or the pharmaceutically-acceptable salt thereof; and

c) administering the diluted unit dosage form to the human by intravenous administration;
wherein:
the unit dosage form has a pH of 3.5 to 4.1;
the administration provides to the human from about 0.01 units of vasopressin or the pharmaceutically-acceptable salt thereof
per minute to about 0.1 units of vasopressin or the pharmaceutically-acceptable salt thereof per minute; and

the human is hypotensive.
US Pat. No. 9,968,649

VASOPRESSIN FORMULATIONS FOR USE IN TREATMENT OF HYPOTENSION

Par Pharmaceutical, Inc.,...

1. A method of increasing blood pressure in a human in need thereof, the method comprising:providing a unit dosage form, wherein the unit dosage form comprises from about 0.1 units/mL to about 1 unit/mL of vasopressin or the pharmaceutically-acceptable salt thereof,
wherein the unit dosage form has a pH of 3.6 to 3.9;
the unit dosage form further comprises impurities that are present in an amount of 0.9%-1.7%, wherein the impurities have from about 85% to about 100% sequence homology to SEQ ID NO.: 1, dextrose, and from about 1 mM to about 10 mM acetate buffer;
storing the unit dosage form for at least about 24 hours at from about 0.1 units/ml to about 1 unit/ml vasopressin or a pharmaceutically-acceptable salt thereof;
after the storing, intravenously administering the unit dosage form to the human;
wherein the administration provides to the human from about 0.01 units of vasopressin or the pharmaceutically-acceptable salt thereof per minute to about 0.1 units of vasopressin or the pharmaceutically-acceptable salt thereof per minute,
wherein the unit dosage form that is administered to the human comprises from about 0.1 units/mL to about 1 unit/mL of vasopressin or the pharmaceutically-acceptable salt thereof; and
the human is hypotensive.
US Pat. No. 10,010,575

VASOPRESSIN FORMULATIONS FOR USE IN TREATMENT OF HYPOTENSION

Par Pharmaceutical, Inc.,...

1. A method of increasing blood pressure in a human in need thereof, the method comprising:providing a pharmaceutical composition that comprises, in a unit dosage form: i) from about 0.1 ?g/mL to about 2 ?g/mL of vasopressin or a pharmaceutically-acceptable salt thereof; ii) dextrose; iii) from about 1 mM to about 10 mM acetate buffer; and iv) SEQ ID NO.: 3, wherein the unit dosage form has a pH of 3.6 to 3.9;
storing the unit dosage form for at least about 24 hours at a concentration of from about 0.1 ug/ml to about 2 ?g/ml of vasopressin or a pharmaceutically-acceptable salt thereof; and
after the storing, intravenously administering the unit dosage form to the human;
wherein:
the administration provides to the human from about 0.01 units of vasopressin or the pharmaceutically-acceptable salt thereof per minute to about 0.1 units of vasopressin or the pharmaceutically-acceptable salt thereof per minute,
wherein the vasopressin or the pharmaceutically-acceptable salt thereof and SEQ ID NO.:3 are present in the unit dosage form at a ratio of about 1000:about 1 to about 90:about 1,
wherein the unit dosage form that is administered to the human comprises from about 0.1 ?g/mL to about 2 ?g/mL of vasopressin or the pharmaceutically-acceptable salt thereof; and
the human is hypotensive.
US Pat. No. 9,962,422

VASOPRESSIN FORMULATIONS FOR USE IN TREATMENT OF HYPOTENSION

PAR PHARMACEUTICAL, INC.,...

1. A method of increasing blood pressure in a human in need thereof, the method comprising:providing a pharmaceutical composition that comprises, in a unit dosage form: i) from about 0.1 ?g/mL to about 2 ?g/mL of vasopressin or a pharmaceutically-acceptable salt thereof; ii) dextrose; iii) from about 1 mM to about 10 mM acetate buffer; and iv) a plurality of peptides in an amount of about 1.5% to about 12.9%, wherein the unit dosage form has a pH of 3.6 to 3.9;
storing the unit dosage form for at least about 24 hours at a concentration of from about 0.1 ?g/ml to about 2 ?g/ml of vasopressin or a pharmaceutically-acceptable salt thereof; and
after the storing, intravenously administering the unit dosage form to the human;
wherein:
the administration provides to the human from about 0.01 units of vasopressin or the pharmaceutically-acceptable salt thereof per minute to about 0.1 units of vasopressin or the pharmaceutically-acceptable salt thereof per minute,
wherein the unit dosage form that is administered to the human comprises from about 0.1 ?g/mL to about 2 ?g/mL of vasopressin or the pharmaceutically-acceptable salt thereof; and
the human is hypotensive.
US Pat. No. 9,415,007

CYANOCOBALAMIN LOW VISCOSITY AQUEOUS FORMULATIONS FOR INTRANASAL DELIVERY

PAR PHARMACEUTICAL, INC.,...

1. A method for elevating a level of vitamin B12 in a subject having vitamin B12 deficiency associated with gastric surgery,
comprising:
administering an aqueous solution of cyanocobalamin to the subject having vitamin B12 deficiency associated with gastric surgery,
wherein the aqueous solution of cyanocobalamin comprises:
cyanocobalamin;
water;
a buffer selected from the group consisting of citric acid, sodium citrate, monopotassium phosphate, disodium phosphate, potassium
biphthalate, sodium hydroxide, sodium acetate, acetic acid, and combinations thereof;

optionally, a humectant selected from the group consisting of sorbitol, propylene glycol, and glycerin, and combinations thereof;
and

optionally, a preservative selected from the group consisting of benzyl alcohol, parabens thimerosal, chlorobutanol, benzethonium
chloride, and benzalkonium chloride, and combinations thereof;

wherein the aqueous solution of cyanocobalamin is suitable for intranasal administration, has a viscosity of less than about
1000 cPs, and a bioavailability of cyanocobalamin when administered intranasally of at least about 7% relative to an intramuscular
injection of cyanocobalamin.

US Pat. No. 9,993,520

VASOPRESSIN FORMULATIONS FOR USE IN TREATMENT OF HYPOTENSION

Par Pharmaceutical, Inc.,...

1. A method of increasing blood pressure in a human in need thereof, the method comprising:a) providing a unit dosage form for intravenous administration, wherein the unit dosage form comprises:
i) from about 0.1 units/mL to about 1 unit/mL of vasopressin or a pharmaceutically-acceptable salt thereof;
ii) from about 1 mM to about 10 mM acetate buffer;
iii) 0-2% vasopressin degradation products;
iv) sodium chloride; and
v) water; and
b) storing the unit dosage form for at least about 24 hours at from about 0.1 units/ml to about 1 unit/ml of vasopressin or a pharmaceutically-acceptable salt thereof; and
c) after the storing, administering the unit dosage form to the human by intravenous administration, wherein the unit dosage form that is administered to the human comprises from about 0.1 units/mL to about 1 unit/mL of vasopressin or the pharmaceutically-acceptable salt thereof; wherein:
the unit dosage form has a pH of 3.4 to 3.8; the administration provides to the human from about 0.01 units of vasopressin or the pharmaceutically-acceptable salt thereof per minute to about 0.1 units of vasopressin or the pharmaceutically-acceptable salt thereof per minute; and the human is hypotensive.
US Pat. No. 9,937,223

VASOPRESSIN FORMULATIONS FOR USE IN TREATMENT OF HYPOTENSION

PAR PHARMACEUTICAL, INC.,...

1. A method of increasing blood pressure in a human in need thereof, the method comprising:a) providing a pharmaceutical composition for intravenous administration comprising: i) from about 0.01 mg/mL to about 0.07 mg/mL of vasopressin or a pharmaceutically acceptable salt thereof; ii) acetate buffer; and iii) water, wherein the pharmaceutical composition has a pH from about 3.7 to about 3.8,wherein the pharmaceutical composition is provided in a container;b) puncturing a dispensing region of the container a first time and drawing from the container a portion of the pharmaceutical composition;
c) intravenously administering the portion of the pharmaceutical composition to the human,wherein the administration provides to the human from about 0.01 units of vasopressin or the pharmaceutically acceptable salt thereof per minute to about 0.1 units of vasopressin or the pharmaceutically acceptable salt thereof per minute,wherein the human is hypotensive;d) puncturing the dispensing region of the container a second time and drawing from the container a second portion of the pharmaceutical composition,wherein the second time that the dispensing region of the container is punctured occurs at least 48hours after the first time that the dispensing region of the container is punctured;e) intravenously administering the second portion of the pharmaceutical composition to the human,wherein the administration of the second portion of the pharmaceutical composition provides to the human from about 0.01 units of vasopressin or the pharmaceutically acceptable salt thereof per minute to about 0.1 units of vasopressin or the pharmaceutically acceptable salt thereof per minute.
US Pat. No. 9,925,234

VASOPRESSIN FORMULATIONS FOR USE IN TREATMENT OF HYPOTENSION

PAR PHARMACEUTICAL, INC.,...

1. A method of increasing blood pressure in a human in need thereof, the method comprising:a) providing a unit dosage form for intravenous administration, wherein the unit dosage form comprises:
i) from about 0.1 units/mL to about 1 unit/mL of vasopressin or a pharmaceutically-acceptable salt thereof;
ii) from about 1 mM to about 10 mM acetate buffer;
iii) no more than about 0-2% vasopressin degradation products;
iv) about 5% dextrose; and
v) water; and
b) administering the unit dosage form to the human by intravenous administration, wherein the unit dosage form comprises from about 0.1 units/mL to about 1 unit/mL of vasopressin or the pharmaceutically-acceptable salt thereof; wherein:
the unit dosage form has a pH of 3.6 to 3.9; the administration provides to the human from about 0.01 units of vasopressin or the pharmaceutically-acceptable salt thereof per minute to about 0.1 units of vasopressin or the pharmaceutically-acceptable salt thereof per minute; and the human is hypotensive.
US Pat. No. 9,974,827

VASOPRESSIN FORMULATIONS FOR USE IN TREATMENT OF HYPOTENSION

Par Pharmaceutical, Inc.,...

1. A method of increasing blood pressure in a human in need thereof, the method comprising:a) providing a pharmaceutical composition comprising, in a unit dosage form: i) from about 0.1 ?g/mL to about 2 ?g/mL of vasopressin or a pharmaceutically-acceptable salt thereof; ii) dextrose; and iii) from about 1 mM to about 10 mM acetate buffer; wherein the unit dosage form has a pH of 3.6 to 3.9;
b) storing intravenously the unit dosage form at 2-8° C. for at least about 24 hours; and
c) after the storing, administering the unit dosage form to the human, wherein the unit dosage form comprises from about 0.1 ?g/mL to about 2 ?g/mL of vasopressin or the pharmaceutically-acceptable salt thereof;
wherein:
the administration provides to the human from about 0.01 units of vasopressin or the pharmaceutically-acceptable salt thereof per minute to about 0.1 units of vasopressin or the pharmaceutically-acceptable salt thereof per minute; and
the human is hypotensive.
US Pat. No. 9,744,209

VASOPRESSIN FORMULATIONS FOR USE IN TREATMENT OF HYPOTENSION

PAR PHARMACEUTICAL, INC.,...

1. A method of increasing blood pressure in a human in need thereof, the method comprising administering to the human a unit
dosage form, wherein the unit dosage form comprises from about 0.01 mg/mL to about 0.07 mg/mL of vasopressin or a pharmaceutically
acceptable salt thereof, wherein:
the unit dosage form has a pH of 3.7-3.9;
the unit dosage form further comprises impurities that are present in an amount of 0.9% - 1.7%, wherein the impurities have
from about 85% to about 100% sequence homology to SEQ ID NO.: 1;

the administration provides to the human from about 0.01 units of vasopressin or the pharmaceutically-acceptable salt thereof
per minute to about 0.1 units of vasopressin or the pharmaceutically-acceptable salt thereof per minute; and

the human is hypotensive.

US Pat. No. 9,919,026

VASOPRESSIN FORMULATIONS FOR USE IN TREATMENT OF HYPOTENSION

PAR PHARMACEUTICAL, INC.,...

1. A pharmaceutical composition for intravenous administration comprising, in a unit dosage form:
from about 0.1 ?g/mL to about 2 ?g/mL of vasopressin or a pharmaceutically-acceptable salt thereof;
impurities that are present in an amount of 0.9% to 1.7%, wherein the impurities have from about 85% to about 100% sequence
homology to SEQ ID NO.: 1;

about 5% dextrose;
and from about 1 mM to about 10 mM acetate buffer, and wherein the unit dosage form has a pH of 3.6 to 3.9;
and wherein the unit dosage form is suitable for administration at a concentration of from about 0.1 ?g/ml to about 2 ?g/ml
of vasopressin or the pharmaceutically acceptable salt thereof.

US Pat. No. 9,750,785

VASOPRESSIN FORMULATIONS FOR USE IN TREATMENT OF HYPOTENSION

PAR PHARMACEUTICAL, INC.,...

1. A pharmaceutical composition comprising, in a unit dosage form, from about 0.01 mg/mL to about 0.07 mg/mL of vasopressin
or a pharmaceutically-acceptable salt thereof, wherein the unit dosage form further comprises impurities that are present
in an amount of 0.9% to 1.7%, wherein the impurities have from about 85% to about 100% sequence homology to SEQ ID NO.: 1,
and wherein the unit dosage form has a pH of 3.7-3.9.
US Pat. No. 10,130,592

EPINEPHRINE FORMULATIONS

PAR PHARMACEUTICAL, INC.,...

1. A composition comprising:epinephrine and/or salts thereof,
an antioxidant present at a concentration of in the range of about 0.1 to 0.9 mg/mL,
a buffer system, the buffer system comprising tartaric acid,
sodium chloride as a tonicity regulating agent at a concentration of in the range of about 6 to 7.5 mg/mL,
a preservative, and
disodium edetate dihydrate as a transition metal complexing agent at a concentration of in the range of about 0.01 to 0.4 mg/mL,
wherein the buffer system provides a resistance to a pH change such that the composition has a pH of in the range of about 3.5 and 4.0 after 18 months of shelf life, and wherein after 18 months of storage at between 23° C. and 32° C. and between 55% RH and 70% RH, the composition comprises about 3% or less of D-Epinephrine.
US Pat. No. 9,925,233

VASOPRESSIN FORMULATIONS FOR USE IN TREATMENT OF HYPOTENSION

PAR PHARMACEUTICAL, INC.,...

1. A method of increasing blood pressure in a human in need thereof, the method comprising:a) storing at 5° C. for at least about one month a pharmaceutical composition for intravenous administration comprising, in a unit dosage form: i) from about 0.1 ?g/mL to about 2 ?g/mL of vasopressin or a pharmaceutically-acceptable salt thereof; ii) dextrose; and iii) from about 1 mM to about 10 mM acetate buffer, wherein the unit dosage form has a pH of 3.6 to 3.9,
wherein the pharmaceutical composition exhibits no more than about 1% degradation of vasopressin or the pharmaceutically-acceptable salt thereof after the storage at 5° C. for about one month; and
b) administering to the human the pharmaceutical composition, wherein the pharmaceutical composition comprises from about 0.1 ?g/mL to about 2 ?g/mL of vasopressin or the pharmaceutically acceptable salt thereof;
wherein the administration provides to the human from about 0.01 units of vasopressin or the pharmaceutically-acceptable salt thereof per minute to about 0.1 units of vasopressin or the pharmaceutically-acceptable salt thereof per minute; and
the human is hypotensive.
US Pat. No. 10,624,864

EPINEPHRINE FORMULATIONS

PAR PHARMACEUTICAL, INC.,...

1. A pre-filled syringe containing a composition, the composition comprising:epinephrine and/or salts thereof,
an antioxidant present at a concentration of in the range of about 0.1 to 0.9 mg/mL,
a buffer system, the buffer system comprising tartaric acid,
sodium chloride as a tonicity regulating agent at a concentration of in the range of about 6 to 7.5 mg/mL,
a preservative, and
disodium edetate dihydrate as a transition metal complexing agent at a concentration of in the range of about 0.01 to 0.4 mg/mL,
wherein the buffer system provides a resistance to a pH change such that the composition has a pH of in the range of about 3.5 and 4.0 after 18 months of shelf life, and wherein after 18 months of storage at between 23° C. and 32° C. and between 55% RH and 70% RH, the composition comprises about 3% or less of D-Epinephrine.
US Pat. No. 10,920,278

METHOD TO TREAT HYPOTENSION USING VASOPRESSIN IN CERTAIN GENOTYPES

PAR PHARMACEUTICAL, INC.,...

1. A method of increasing blood pressure to a target blood pressure in a human patient with post-cardiotomy shock wherein the patient has an LNPEP AA or AT rs4869317 genotype, the method comprising: intravenously administering to the patient a pharmaceutical formulation comprising vasopressin at a starting dose of 0.03 units/minute and titrating the dose up by 0.005 units/minute at 10 to 15 minute intervals to maintain the target blood pressure, wherein the maximum dose is 0.121 units/minute.