Aspirin; dipyridamole - Generic Drug Details
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What are the generic drug sources for aspirin; dipyridamole and what is the scope of freedom to operate?
Aspirin; dipyridamole
is the generic ingredient in two branded drugs marketed by Boehringer Ingelheim, Amneal Pharms, Ani Pharms, Barr, Chartwell Molecular, Dr Reddys, Endo Operations, Glenmark Speclt, Micro Labs, Sandoz, Sun Pharm, and Zydus Pharms, and is included in twelve NDAs. Additional information is available in the individual branded drug profile pages.Ten suppliers are listed for this compound.
Summary for aspirin; dipyridamole
| US Patents: | 0 |
| Tradenames: | 2 |
| Applicants: | 12 |
| NDAs: | 12 |
| Finished Product Suppliers / Packagers: | 10 |
| Raw Ingredient (Bulk) Api Vendors: | 6 |
| Clinical Trials: | 25 |
| Patent Applications: | 92 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for aspirin; dipyridamole |
| DailyMed Link: | aspirin; dipyridamole at DailyMed |
Recent Clinical Trials for aspirin; dipyridamole
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Rutgers, The State University of New Jersey | Phase 3 |
| Région Hauts de France, France | Phase 3 |
| Ministry of Health, France | Phase 3 |
Pharmacology for aspirin; dipyridamole
| Drug Class | Nonsteroidal Anti-inflammatory Drug Platelet Aggregation Inhibitor |
| Mechanism of Action | Cyclooxygenase Inhibitors |
| Physiological Effect | Decreased Platelet Aggregation Decreased Prostaglandin Production |
Anatomical Therapeutic Chemical (ATC) Classes for aspirin; dipyridamole
Paragraph IV (Patent) Challenges for ASPIRIN; DIPYRIDAMOLE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| AGGRENOX | Extended-release Capsules | aspirin; dipyridamole | 25 mg and 200 mg | 020884 | 1 | 2007-02-01 |
US Patents and Regulatory Information for aspirin; dipyridamole
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sandoz | ASPIRIN AND DIPYRIDAMOLE | aspirin; dipyridamole | CAPSULE, EXTENDED RELEASE;ORAL | 206739-001 | Jan 18, 2017 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Micro Labs | ASPIRIN AND DIPYRIDAMOLE | aspirin; dipyridamole | CAPSULE, EXTENDED RELEASE;ORAL | 209929-001 | Aug 11, 2021 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Dr Reddys | ASPIRIN AND DIPYRIDAMOLE | aspirin; dipyridamole | CAPSULE, EXTENDED RELEASE;ORAL | 209048-001 | Oct 10, 2018 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Glenmark Speclt | ASPIRIN AND DIPYRIDAMOLE | aspirin; dipyridamole | CAPSULE, EXTENDED RELEASE;ORAL | 210318-001 | May 24, 2019 | AB | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Amneal Pharms | ASPIRIN AND DIPYRIDAMOLE | aspirin; dipyridamole | CAPSULE, EXTENDED RELEASE;ORAL | 206392-001 | Mar 8, 2016 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Ani Pharms | ASPIRIN AND DIPYRIDAMOLE | aspirin; dipyridamole | CAPSULE, EXTENDED RELEASE;ORAL | 206964-001 | Jan 18, 2017 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Barr | ASPIRIN AND DIPYRIDAMOLE | aspirin; dipyridamole | CAPSULE, EXTENDED RELEASE;ORAL | 078804-001 | Aug 14, 2009 | AB | RX | No | 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 aspirin; dipyridamole
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Boehringer Ingelheim | AGGRENOX | aspirin; dipyridamole | CAPSULE, EXTENDED RELEASE;ORAL | 020884-001 | Nov 22, 1999 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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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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