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Last Updated: November 22, 2024

ADENOSINE - Generic Drug Details


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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
Drug Prices for ADENOSINE

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Recent Clinical Trials for ADENOSINE

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

SponsorPhase
MedSIRPhase 2
The University of Texas Health Science Center, HoustonPhase 4
Society of Cardiovascular AnesthesiologistsPhase 4

See all ADENOSINE clinical trials

Generic filers with tentative approvals for ADENOSINE
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign Up3MG/MLINJECTABLE; INJECTION
⤷  Sign Up⤷  Sign Up3MG/MLINJECTABLE; 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
Medical Subject Heading (MeSH) Categories for ADENOSINE
Anatomical Therapeutic Chemical (ATC) Classes for ADENOSINE
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
Mylan Labs Ltd ADENOSINE adenosine INJECTABLE;INJECTION 078686-001 May 13, 2009 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Mylan Asi ADENOSINE adenosine SOLUTION;INTRAVENOUS 090212-002 Mar 28, 2014 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Mylan Asi ADENOSINE adenosine SOLUTION;INTRAVENOUS 090212-001 Mar 28, 2014 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Meitheal ADENOSINE adenosine SOLUTION;INTRAVENOUS 077425-002 Aug 29, 2013 AP RX No Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Astellas ADENOSCAN adenosine SOLUTION;INTRAVENOUS 020059-002 May 18, 1995 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for ADENOSINE

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

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