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Last Updated: September 22, 2020

DrugPatentWatch Database Preview

Adenosine - Generic Drug Details

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What are the generic drug sources for adenosine and what is the scope of patent protection?

Adenosine is the generic ingredient in three branded drugs marketed by Astellas, Akorn, Am Regent, Fresenius Kabi Usa, Gland Pharma Ltd, Mylan Labs Ltd, Teva Pharms Usa, West-ward Pharms Int, Wockhardt, Aurobindo Pharma Ltd, Emcure Pharms Ltd, Hospira Inc, 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. Fourteen suppliers are listed for this compound. There are two tentative approvals for this compound.

Drug Prices for adenosine

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Recent Clinical Trials for adenosine

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

SponsorPhase
Alliance for Clinical Trials in OncologyPhase 3
University of IowaPhase 2
University of KentuckyPhase 2

See all adenosine clinical trials

Generic filers with tentative approvals for ADENOSINE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial3MG/MLINJECTABLE; INJECTION
  Start Trial  Start Trial3MG/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
Paragraph IV (Patent) Challenges for ADENOSINE
Tradename Dosage Ingredient NDA Submissiondate
ADENOSCAN SOLUTION;INTRAVENOUS adenosine 020059 2005-04-16

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
Aurobindo Pharma Ltd ADENOSINE adenosine SOLUTION;INTRAVENOUS 205331-002 Nov 2, 2017 AP RX No No   Start Trial   Start Trial   Start Trial
Aurobindo Pharma Ltd ADENOSINE adenosine SOLUTION;INTRAVENOUS 205331-001 Nov 2, 2017 AP RX No No   Start Trial   Start Trial   Start Trial
Akorn ADENOSINE adenosine INJECTABLE;INJECTION 078076-001 Oct 31, 2008 AP RX No Yes   Start Trial   Start Trial   Start Trial
>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   Start Trial   Start Trial
Astellas ADENOSCAN adenosine SOLUTION;INTRAVENOUS 020059-002 May 18, 1995   Start Trial   Start Trial
Astellas ADENOSCAN adenosine SOLUTION;INTRAVENOUS 020059-001 May 18, 1995   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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