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Last Updated: March 19, 2024

Adenosine - Generic Drug Details


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What are the generic drug 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.

Drug Prices for adenosine

See drug prices for adenosine

Recent Clinical Trials for adenosine

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

SponsorPhase
Artios Pharma LtdPhase 1/Phase 2
Arab Contractors Medical CentrePhase 4
Qianfoshan HospitalN/A

See all adenosine clinical trials

Generic filers with tentative approvals for ADENOSINE
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial3MG/MLINJECTABLE; INJECTION
⤷  Try a Trial⤷  Try a 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 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 Asi ADENOSINE adenosine SOLUTION;INTRAVENOUS 090212-001 Mar 28, 2014 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan Labs Ltd ADENOSINE adenosine INJECTABLE;INJECTION 078640-001 Mar 21, 2014 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hikma ADENOSINE adenosine INJECTABLE;INJECTION 076501-001 Jun 16, 2004 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Eugia Pharma ADENOSINE adenosine SOLUTION;INTRAVENOUS 205331-002 Nov 2, 2017 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hikma ADENOSINE adenosine INJECTABLE;INJECTION 076500-001 Jun 16, 2004 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  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

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 ⤷  Try a Trial ⤷  Try a Trial
Astellas ADENOSCAN adenosine SOLUTION;INTRAVENOUS 020059-002 May 18, 1995 ⤷  Try a Trial ⤷  Try a Trial
Astellas ADENOSCAN adenosine SOLUTION;INTRAVENOUS 020059-001 May 18, 1995 ⤷  Try a Trial ⤷  Try a Trial
Astellas ADENOSCAN adenosine SOLUTION;INTRAVENOUS 020059-001 May 18, 1995 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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