ADENOSINE - Generic Drug Details

What are the generic sources for adenosine and what is the scope of freedom to operate?

Adenosine is the generic ingredient in three branded drugs marketed by Astellas, Am Regent, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Mylan Labs Ltd, Rising, Teva Pharms Usa, Wockhardt, Avet Lifesciences, Eugia Pharma, Hospira, Meitheal, and Mylan Asi, and is included in twenty-three NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-six drug master file entries for adenosine. Thirteen suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for ADENOSINE

US Patents:	0
Tradenames:	3
Applicants:	14
NDAs:	23
Drug Master File Entries:	26
Finished Product Suppliers / Packagers:	13
Raw Ingredient (Bulk) Api Vendors:	161
Clinical Trials:	610
Drug Prices:	Drug price trends for ADENOSINE
What excipients (inactive ingredients) are in ADENOSINE?	ADENOSINE excipients list
DailyMed Link:	ADENOSINE at DailyMed

See drug prices for ADENOSINE

Recent Clinical Trials for ADENOSINE

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

Sponsor	Phase
MedSIR	Phase 2
The University of Texas Health Science Center, Houston	Phase 4
Society of Cardiovascular Anesthesiologists	Phase 4

See all ADENOSINE clinical trials

Generic filers with tentative approvals for ADENOSINE

Applicant	Application No.	Strength	Dosage Form
		3MG/ML	INJECTABLE; INJECTION
		3MG/ML	INJECTABLE; INJECTION

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for ADENOSINE

Drug Class	Adenosine Receptor Agonist
Mechanism of Action	Adenosine Receptor Agonists

Medical Subject Heading (MeSH) Categories for ADENOSINE

Analgesics

Anti-Arrhythmia Agents

Purinergic P1 Receptor Agonists

Vasodilator Agents

Anatomical Therapeutic Chemical (ATC) Classes for ADENOSINE

C01EB	Other cardiac preparations
C01E	OTHER CARDIAC PREPARATIONS
C01	CARDIAC THERAPY
C	Cardiovascular system

Paragraph IV (Patent) Challenges for ADENOSINE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ADENOSCAN	Injection	adenosine	3 mg/mL, 20 mL and 30 mL vials	020059	1	2005-04-18

US Patents and Regulatory Information for ADENOSINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Teva Pharms Usa	ADENOSINE	adenosine	INJECTABLE;INJECTION	078676-001	Jul 31, 2008		DISCN	No	No
Astellas	ADENOSCAN	adenosine	SOLUTION;INTRAVENOUS	020059-001	May 18, 1995		DISCN	Yes	No
Fresenius Kabi Usa	ADENOSINE	adenosine	SOLUTION;INTRAVENOUS	077897-002	Nov 27, 2017	AP	RX	No	No
Hikma	ADENOSINE	adenosine	INJECTABLE;INJECTION	076501-001	Jun 16, 2004		DISCN	No	No
Meitheal	ADENOSINE	adenosine	SOLUTION;INTRAVENOUS	077425-001	Aug 29, 2013	AP	RX	No	Yes
Mylan Asi	ADENOSINE	adenosine	SOLUTION;INTRAVENOUS	090212-002	Mar 28, 2014	AP	RX	No	No
Mylan Labs Ltd	ADENOSINE	adenosine	INJECTABLE;INJECTION	078686-001	May 13, 2009	AP	RX	No	No

Expired US Patents for ADENOSINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astellas	ADENOSCAN	adenosine	SOLUTION;INTRAVENOUS	020059-002	May 18, 1995
Astellas	ADENOCARD	adenosine	INJECTABLE;INJECTION	019937-002	Oct 30, 1989
Astellas	ADENOSCAN	adenosine	SOLUTION;INTRAVENOUS	020059-001	May 18, 1995
Astellas	ADENOSCAN	adenosine	SOLUTION;INTRAVENOUS	020059-001	May 18, 1995