Adrenalin Drug Patent Profile

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Which patents cover Adrenalin, and what generic alternatives are available?

Adrenalin is a drug marketed by Par Sterile Products and is included in three NDAs. There are six patents protecting this drug and two Paragraph IV challenges.

This drug has nine patent family members in seven countries.

The generic ingredient in ADRENALIN is epinephrine. There are twenty-one drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the epinephrine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Adrenalin

A generic version of Adrenalin was approved as epinephrine by BPI LABS on July 29^th, 2014.

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Summary for Adrenalin

International Patents:	9
US Patents:	6
Applicants:	1
NDAs:	3
Finished Product Suppliers / Packagers:	7
Raw Ingredient (Bulk) Api Vendors:	88
Clinical Trials:	44
Patent Applications:	3,844
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for Adrenalin
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for Adrenalin
What excipients (inactive ingredients) are in Adrenalin?	Adrenalin excipients list
DailyMed Link:	Adrenalin at DailyMed

Drug patent expirations by year for Adrenalin

Recent Clinical Trials for Adrenalin

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Rambam Health Care Campus	Phase 2
Constant Therapeutics LLC	Phase 2
Tomsk National Research Medical Center of the Russian Academy of Sciences	N/A

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Pharmacology for Adrenalin

Drug Class	Catecholamine alpha-Adrenergic Agonist beta-Adrenergic Agonist
Mechanism of Action	Adrenergic alpha-Agonists Adrenergic beta-Agonists

Anatomical Therapeutic Chemical (ATC) Classes for Adrenalin

A01AD	Other agents for local oral treatment
A01A	STOMATOLOGICAL PREPARATIONS
A01	STOMATOLOGICAL PREPARATIONS
A	Alimentary tract and metabolism

B02BC	Local hemostatics
B02B	VITAMIN K AND OTHER HEMOSTATICS
B02	ANTIHEMORRHAGICS
B	Blood and blood forming organs

C01CA	Adrenergic and dopaminergic agents
C01C	CARDIAC STIMULANTS EXCL. CARDIAC GLYCOSIDES
C01	CARDIAC THERAPY
C	Cardiovascular system

R01AA	Sympathomimetics, plain
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

R03AA	Alpha- and beta-adrenoreceptor agonists
R03A	ADRENERGICS, INHALANTS
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

S01EA	Sympathomimetics in glaucoma therapy
S01E	ANTIGLAUCOMA PREPARATIONS AND MIOTICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

Paragraph IV (Patent) Challenges for ADRENALIN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ADRENALIN	Injection	epinephrine	30 mg/30 mL	204640	1	2018-08-20
ADRENALIN	Injection	epinephrine	1 mg/mL ampules	204200	1	2016-03-09

US Patents and Regulatory Information for Adrenalin

Adrenalin is protected by six US patents.

Patents protecting Adrenalin

Epinephrine formulations
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

Epinephrine compositions and containers
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

Epinephrine compositions and containers
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TO INCREASE MEAN ARTERIAL BLOOD PRESSURE IN ADULT PATIENTS WITH HYPOTENSION ASSOCIATED WITH SEPTIC SHOCK

Epinephrine compositions and containers
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

Epinephrine formulations
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

Epinephrine formulations
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: EMERGENCY TREATMENT OF ALLERGIC REACTIONS (TYPE I), INCLUDING ANAPHYLAXIS

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Par Sterile Products	ADRENALIN	epinephrine	SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	204200-001	Dec 7, 2012		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Par Sterile Products	ADRENALIN	epinephrine	SOLUTION;INTRAVENOUS	215875-005	Apr 21, 2023		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Par Sterile Products	ADRENALIN	epinephrine	SOLUTION;INTRAVENOUS	215875-001	Apr 21, 2023		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Par Sterile Products	ADRENALIN	epinephrine	SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	204640-001	Dec 18, 2013	AP	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Par Sterile Products	ADRENALIN	epinephrine	SOLUTION;INTRAVENOUS	215875-003	Apr 21, 2023		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Par Sterile Products	ADRENALIN	epinephrine	SOLUTION;INTRAVENOUS	215875-005	Apr 21, 2023		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Par Sterile Products	ADRENALIN	epinephrine	SOLUTION;INTRAVENOUS	215875-001	Apr 21, 2023		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

International Patents for Adrenalin

See the table below for patents covering Adrenalin around the world.

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Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2019183416		⤷ Try a Trial
Australia	2016233682	Epinephrine formulations	⤷ Try a Trial
China	107614017	肾上腺素制剂 (EPINEPHRINE FORMULATIONS)	⤷ Try a Trial
European Patent Office	3268045	FORMULATIONS D'ÉPINÉPHRINE (EPINEPHRINE FORMULATIONS)	⤷ Try a Trial
South Korea	20180034307	에피네프린 제형	⤷ Try a Trial
Japan	2018507915	エピネフリン製剤	⤷ Try a Trial
Canada	3093725	COMPOSITIONS ET RECIPIENTS D'EPINEPHRINE (EPINEPHRINE COMPOSITIONS AND CONTAINERS)	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration