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 four 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. Sixteen 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 HOSPIRA on July 14th, 2015.
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: | 4,430 |
| Formulation / Manufacturing: | see details |
| 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 |
Anatomical Therapeutic Chemical (ATC) Classes for ANGIOMAX
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 | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
| Maia Pharms Inc | ANGIOMAX RTU | bivalirudin | SOLUTION;INTRAVENOUS | 211215-001 | Jul 25, 2019 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Sandoz | ANGIOMAX | bivalirudin | INJECTABLE;INTRAVENOUS | 020873-001 | Dec 15, 2000 | AP | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ 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 ANGIOMAX
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Sandoz | ANGIOMAX | bivalirudin | INJECTABLE;INTRAVENOUS | 020873-001 | Dec 15, 2000 | ⤷ Try a Trial | ⤷ Try a Trial |
| >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 |
|---|---|---|---|
| Mexico | 9203196 | NUEVOS INHIBIDORES DE TROMBINA. | ⤷ Try a Trial |
| Finland | 120348 | ⤷ Try a Trial | |
| Bulgaria | 60759 | ⤷ Try a Trial | |
| >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 | ⤷ Try a Trial | |
| 0489070 | SPC/GB04/035 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: H-(D-PHE)-PRO-ARG-PRO-(GLY)4-ASN-GLY-ASP-PHE-GLU-GLU-ILE-PRO-GLU-GLU-TYR-LEU-OH, OPTIONALLY IN THE FORM OF ITS PHARMACEUTICALLY ACCEPTABLE SALT (BIVALIRUDIN); REGISTERED: UK EU/1/04/289/001 20040920 |
| 0489070 | 91119 | Luxembourg | ⤷ Try a Trial | 91119, EXPIRES: 20150817 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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.
ISSN: 2162-2639
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