ANGIOMAX Drug Patent Profile
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When do Angiomax patents expire, and when can generic versions of Angiomax launch?
Angiomax is a drug marketed by Sandoz and Maia Pharms Inc and is included in two NDAs. There are five patents protecting this drug and one Paragraph IV challenge.
The generic ingredient in ANGIOMAX is bivalirudin. There are fourteen drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the bivalirudin profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Angiomax
A generic version of ANGIOMAX was approved as bivalirudin by FRESENIUS KABI USA on October 28th, 2016.
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Questions you can ask:
- What is the 5 year forecast for ANGIOMAX?
- What are the global sales for ANGIOMAX?
- What is Average Wholesale Price for ANGIOMAX?
Summary for ANGIOMAX
| US Patents: | 2 |
| Applicants: | 2 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 3 |
| Raw Ingredient (Bulk) Api Vendors: | 61 |
| Clinical Trials: | 19 |
| Patent Applications: | 4,423 |
| Drug Prices: | Drug price information for ANGIOMAX |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ANGIOMAX |
| What excipients (inactive ingredients) are in ANGIOMAX? | ANGIOMAX excipients list |
| DailyMed Link: | ANGIOMAX at DailyMed |
Recent Clinical Trials for ANGIOMAX
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Legacy Health System | Phase 4 |
| Pacific University | Phase 4 |
| Qian Gong | Phase 2 |
Pharmacology for ANGIOMAX
| Drug Class | Anti-coagulant Direct Thrombin Inhibitor |
| Mechanism of Action | Thrombin Inhibitors |
Paragraph IV (Patent) Challenges for ANGIOMAX
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| ANGIOMAX | For Injection | bivalirudin | 250 mg/vial | 020873 | 1 | 2009-09-01 |
US Patents and Regulatory Information for ANGIOMAX
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sandoz | ANGIOMAX | bivalirudin | INJECTABLE;INTRAVENOUS | 020873-001 | Dec 15, 2000 | AP | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Maia Pharms Inc | ANGIOMAX RTU | bivalirudin | SOLUTION;INTRAVENOUS | 211215-001 | Jul 25, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Sandoz | ANGIOMAX | bivalirudin | INJECTABLE;INTRAVENOUS | 020873-001 | Dec 15, 2000 | AP | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Maia Pharms Inc | ANGIOMAX RTU | bivalirudin | SOLUTION;INTRAVENOUS | 211215-001 | Jul 25, 2019 | RX | Yes | Yes | ⤷ 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 ANGIOMAX
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Sandoz | ANGIOMAX | bivalirudin | INJECTABLE;INTRAVENOUS | 020873-001 | Dec 15, 2000 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for ANGIOMAX
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| The Medicines Company UK Ltd | Angiox | bivalirudin | EMEA/H/C/000562 Angiox is indicated as an anticoagulant in adult patients undergoing percutaneous coronary intervention (PCI), including patients with ST-segment-elevation myocardial infarction (STEMI) undergoing primary PCI.Angiox is also indicated for the treatment of adult patients with unstable angina / non-ST-segment-elevation myocardial infarction (UA / NSTEMI) planned for urgent or early intervention.Angiox should be administered with aspirin and clopidogrel. |
Withdrawn | no | no | no | 2004-09-20 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for ANGIOMAX
See the table below for patents covering ANGIOMAX around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Germany | 122004000042 | ⤷ Sign Up | |
| Germany | 69026715 | ⤷ Sign Up | |
| Finland | 20050027 | ⤷ Sign Up | |
| Hong Kong | 1005995 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ANGIOMAX
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0489070 | CA 2004 00032 | Denmark | ⤷ Sign Up | |
| 0489070 | 22/2004 | Austria | ⤷ Sign Up | PRODUCT NAME: BIVALIRUDIN UND TRIFLUORACETAT DAVON; REGISTRATION NO/DATE: EU/1/04/289/001 20040920 |
| 0489070 | 300162 | Netherlands | ⤷ Sign Up | PRODUCT NAME: BIVALIRUDINE; FIRST REGISTRATION,DATE: EU/1/04/289/001, 20040920 |
| 0489070 | 91119 | Luxembourg | ⤷ Sign Up | 91119, EXPIRES: 20150817 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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