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
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 |
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 |
Generic filers with tentative approvals for ADENOSINE
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 3MG/ML | INJECTABLE; INJECTION |
⤷ Sign Up | ⤷ Sign Up | 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
Anatomical Therapeutic Chemical (ATC) Classes for ADENOSINE
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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