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Aspirin - Generic Drug Details
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What are the generic drug sources for aspirin and what is the scope of aspirin freedom to operate?
Aspirin
is the generic ingredient in fifty-three branded drugs marketed by New Haven Pharms, Plx Pharma, Bayer, Savage Labs, Nostrum Labs Inc, Watson Labs, Allergan Sales Llc, Lannett, Actavis Elizabeth, Fosun Pharma, Halsey, Hikma Intl Pharms, Ivax Pharms, PII, Puracap Pharm, Quantum Pharmics, Mayne Pharma Inc, Nexgen Pharma Inc, Stevens J, Vintage Pharms Llc, Sun Pharm Industries, Sandoz, Medicis, Galt Pharms, Alra, Xanodyne Pharm, Ivax Sub Teva Pharms, Teva, Heritage Pharms Inc, Novast Labs Ltd, Oxford Pharms, Meda Pharms, Ingenus Pharms Nj, Boehringer Ingelheim, Amneal Pharms, Ani Pharms Inc, Barr, Par Pharm Inc, Sandoz Inc, Zydus Pharms Usa Inc, Schwarz Pharma, Abbott, Par Pharm, Medpointe Pharm Hlc, Mcneil, Robins Ah, Genus Lifesciences, Actavis Labs Fl Inc, Endo Pharms, Roxane, Sanofi Aventis Us, Bristol Myers Squibb, and Aaipharma Llc, and is included in eighty-one NDAs. There are ten patents protecting this compound. Additional information is available in the individual branded drug profile pages.Aspirin has thirty-three patent family members in eighteen countries.
There are twenty-one drug master file entries for aspirin. One supplier is listed for this compound.
Summary for aspirin
| International Patents: | 33 |
| US Patents: | 10 |
| Tradenames: | 53 |
| Applicants: | 53 |
| NDAs: | 81 |
| Drug Master File Entries: | 21 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 96 |
| Clinical Trials: | 1,138 |
| Patent Applications: | 6,597 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for aspirin |
| DailyMed Link: | aspirin at DailyMed |
Pharmacology for aspirin
| Ingredient-type | Nonsteroidal Anti-inflammatory Compounds |
| Drug Class | Nonsteroidal Anti-inflammatory Drug Platelet Aggregation Inhibitor |
| Mechanism of Action | Cyclooxygenase Inhibitors |
| Physiological Effect | Decreased Prostaglandin Production Decreased Platelet Aggregation |
Medical Subject Heading (MeSH) Categories for aspirin
Synonyms for aspirin
| (non-d)Acetylsalicylic Acid-d3 |
| 11126-35-5 |
| 11126-37-7 |
| 170197-EP2275413A1 |
| 170197-EP2287156A1 |
| 1777-EP2269989A1 |
| 1777-EP2269990A1 |
| 1777-EP2272825A2 |
| 1777-EP2275420A1 |
| 1777-EP2277865A1 |
| 1777-EP2280008A2 |
| 1777-EP2281563A1 |
| 1777-EP2281815A1 |
| 1777-EP2281818A1 |
| 1777-EP2292227A2 |
| 1777-EP2295055A2 |
| 1777-EP2298764A1 |
| 1777-EP2298765A1 |
| 1777-EP2298768A1 |
| 1777-EP2298776A1 |
| 1777-EP2305219A1 |
| 1777-EP2305260A1 |
| 1777-EP2305640A2 |
| 1777-EP2305652A2 |
| 1777-EP2308510A1 |
| 1777-EP2311453A1 |
| 1777-EP2314590A1 |
| 1777-EP2314593A1 |
| 1777-EP2316459A1 |
| 1777-EP2371811A2 |
| 186947-EP2270113A1 |
| 186947-EP2272935A1 |
| 1oxr |
| 2-(AcetYl-Oxy)Benzoic Acid |
| 2-(Acetyloxy)-benzoic acid |
| 2-(acetyloxy)benzoate |
| 2-(Acetyloxy)benzoic acid |
| 2-acetoxy benzoic acid |
| 2-Acetoxybenzenecarboxylic acid |
| 2-Acetoxybenzoate |
| 2-Acetoxybenzoic acid |
| 2-ACETOXYBENZOIC ACID COMPOUND WITH 2-AMINO-2-(HYDROXYMETHYL)PROPANE-1 3-DIOL (1:1) |
| 2-Acetoxybenzoic acid; O-Acetylsalicylic acid; ASA; Aspirin |
| 2-acetyloxybenzoic acid |
| 2-Acetylsalicyclic acid |
| 2-Carboxyphenyl acetate |
| 2349-94-2 |
| 24189-EP2295409A1 |
| 24189-EP2314590A1 |
| 26914-13-6 |
| 4-10-00-00138 (Beilstein Handbook Reference) |
| 50-78-2 |
| 6474-EP1441224A2 |
| 6474-EP2272832A1 |
| 6474-EP2275420A1 |
| 6474-EP2277861A1 |
| 6474-EP2277875A2 |
| 6474-EP2298757A2 |
| 6474-EP2298764A1 |
| 6474-EP2298765A1 |
| 6474-EP2314585A1 |
| 8-hour Bayer |
| 98201-60-6 |
| A 5376 |
| A.S.A |
| A.S.A. |
| A.S.A. empirin |
| AB00051918_09 |
| AB00051918_10 |
| AB00051918-08 |
| AB1003266 |
| AC 5230 |
| AC1L1D8U |
| AC1Q1LA0 |
| Acenterine |
| Acesal |
| Acesan |
| Acetard |
| Aceticyl |
| Acetilsalicilico |
| Acetilum acidulatum |
| Acetisal |
| Acetonyl |
| Acetophen |
| Acetosal |
| Acetosalic acid |
| Acetosalin |
| Acetoxybenzoic acid |
| acetyl salicyclic acid |
| acetyl salicylic acid |
| acetyl-salicylic acid |
| Acetylin |
| Acetylsal |
| Acetylsalicyclic acid |
| Acetylsalicylate |
| ACETYLSALICYLIC ACID |
| Acetylsalicylic Acid 1.0 mg/ml in Acetonitrile |
| Acetylsalicylic acid for peak identification, European Pharmacopoeia (EP) Reference Standard |
| ACETYLSALICYLIC ACID-ALPHA-13C |
| Acetylsalicylic acid, >=99.0% |
| Acetylsalicylic acid, >=99% |
| Acetylsalicylic acid, 99% |
| Acetylsalicylic acid, analytical standard |
| ACETYLSALICYLIC ACID, ASPIRIN |
| Acetylsalicylic acid, BioReagent, plant cell culture tested, >=99.0% |
| Acetylsalicylic acid, European Pharmacopoeia (EP) Reference Standard |
| Acetylsalicylic acid, Vetec(TM) reagent grade, >=99% |
| AcetylsalicylicAcid |
| Acetylsalicylsaeure |
| Acetylsalicylsaure |
| Acetylsalicylsaure (GERMAN) |
| Acetylsalicylsaure [German] |
| acetylsalisylic acid |
| Acetylsalycilic acid |
| Acetyonyl |
| Acetysal |
| Acetysalicylic acid |
| acide 2-(acetyloxy)benzoique |
| Acide acetylsalicylique |
| Acide acetylsalicylique (FRENCH) |
| Acide acetylsalicylique [French] |
| Acido acetilsalicilico |
| Acido acetilsalicilico [Italian] |
| Acido O-acetil-benzoico |
| Acido O-acetil-benzoico [Italian] |
| Acidum acetylsalicylicum |
| Acimetten |
| Acisal |
| ACMC-209kpz |
| Acylpyrin |
| Adiro |
| AI3-02956 |
| AIN |
| AJ-07843 |
| AKOS000118884 |
| Aloxiprimum |
| AN-24382 |
| ANW-31125 |
| Arthritis Pain Formula Maximum Strength (Salt/Mix) |
| ASA |
| Asacard |
| Asagran |
| Asaphen |
| Asatard |
| Ascoden-30 |
| Ascolong |
| Ascriptin (Salt/Mix) |
| Aspalon |
| Aspalon (JAN) |
| Aspec |
| Aspergum |
| Aspir-Mox |
| Aspirdrops |
| Aspirin (Acetyl Salicylic Acid), pharmaceutical secondary standard; traceable to USP, PhEur and BP |
| aspirin (acetylsalicylic acid) |
| Aspirin (JP17/USP) |
| Aspirin [BAN:JAN] |
| aspirin lysine |
| ASPIRIN MAGNESIUM |
| Aspirin USP (2080B) |
| Aspirin USP (3080) |
| Aspirin USP-26 |
| Aspirin, British Pharmacopoeia (BP) Reference Standard |
| Aspirin, meets USP testing specifications |
| Aspirin, United States Pharmacopeia (USP) Reference Standard |
| Aspirina 03 |
| Aspirine |
| Asprin |
| Aspro |
| Aspro Clear |
| Aspropharm |
| Asteric |
| Azetylsalizylsaeure |
| Azetylsalizylsaure |
| Bay E4465 |
| BAY-1019036 |
| Bay-e-4465 |
| Bayer |
| Bayer Aspirin 8 Hour |
| Bayer Buffered |
| Bayer Children's Aspirin |
| Bayer Enteric 325 mg Regular Strength |
| Bayer Enteric 500 mg Arthritis Strength |
| Bayer Enteric 81 mg Adult Low Strength |
| Bayer Extra Strength Aspirin for Migraine Pain |
| Bayer Plus |
| BBL005469 |
| BC221833 |
| BDBM22360 |
| Benaspir |
| Benzoic acid, 2-(acetyloxy)- |
| Benzoicacid, 2-(acetyloxy)- |
| Bi-prin |
| Bialpirina |
| Bialpirinia |
| BIDD:GT0118 |
| BRN 0779271 |
| BSYNRYMUTXBXSQ-UHFFFAOYSA-N |
| Bufferin |
| C01405 |
| Cardioaspirin |
| Cardioaspirina |
| CAS-50-78-2 |
| CCG-39490 |
| CCRIS 3243 |
| Cemirit |
| CHEBI:15365 |
| CHEMBL25 |
| cid_2244 |
| Claradin |
| Clariprin |
| cMAP_000006 |
| Colfarit |
| Colsprin |
| component of Ascodeen-30 |
| component of Ascodeen-30 (Salt/Mix) |
| component of Coricidin |
| component of Darvon with A.S.A |
| component of Darvon with A.S.A (Salt/Mix) |
| component of Midol |
| component of Persistin |
| component of Robaxisal |
| component of St. Joseph Cold Tablets |
| component of Synirin |
| component of Zactirin |
| component of Zactirin (Salt/Mix) |
| Contrheuma retard |
| CS-2001 |
| CTK1G9661 |
| D00109 |
| D0GY5Z |
| D0XB8R |
| D41527A7-A9EB-472D-A7FC-312821130549 |
| DB00945 |
| Decaten |
| Delgesic |
| DivK1c_000555 |
| Dolean pH 8 |
| DSSTox_CID_108 |
| DSSTox_GSID_20108 |
| DSSTox_RID_75372 |
| DTXSID5020108 |
| Duramax |
| Easprin |
| Easprin (TN) |
| ECM |
| Ecolen |
| Ecotrin |
| EINECS 200-064-1 |
| Empirin |
| Empirin with Codeine (Salt/Mix) |
| Endosprin |
| Endydol |
| Entericin |
| Enterophen |
| Enterosarein |
| Enterosarine |
| Entrophen |
| Epitope ID:114151 |
| EU-0100038 |
| Extren |
| F2191-0068 |
| FT-0655181 |
| Globentyl |
| Globoid |
| GTPL4139 |
| H740 |
| Helicon |
| HMS1920E13 |
| HMS2090G03 |
| HMS2091K13 |
| HMS2233L18 |
| HMS3260G17 |
| HMS3372N15 |
| HMS3656N14 |
| HMS501L17 |
| HSDB 652 |
| HY-14654 |
| I14-7505 |
| IDI1_000555 |
| Idragin |
| InChI=1/C9H8O4/c1-6(10)13-8-5-3-2-4-7(8)9(11)12/h2-5H,1H3,(H,11,12 |
| Istopirin |
| Kapsazal |
| KB-47125 |
| KBio1_000555 |
| KBio2_001725 |
| KBio2_002271 |
| KBio2_004293 |
| KBio2_004839 |
| KBio2_006861 |
| KBio2_007407 |
| KBio3_002149 |
| KBio3_002751 |
| KBioGR_000398 |
| KBioGR_002271 |
| KBioSS_001725 |
| KBioSS_002272 |
| KS-00000ULP |
| KSC269M6D |
| Kyselina 2-acetoxybenzoova |
| Kyselina 2-acetoxybenzoova [Czech] |
| Kyselina acetylsalicylova |
| Kyselina acetylsalicylova [Czech] |
| Levius |
| Lopac-A-5376 |
| Lopac0_000038 |
| LP00038 |
| LS-143 |
| Magnecyl |
| MCULE-3199019536 |
| Measurin |
| Medisyl |
| MFCD00002430 |
| Micrainin (Salt/Mix) |
| Micristin |
| Miniasal |
| MLS001055329 |
| MLS001066332 |
| MLS001336045 |
| MLS001336046 |
| MolPort-000-871-622 |
| NCGC00015067-01 |
| NCGC00015067-02 |
| NCGC00015067-03 |
| NCGC00015067-04 |
| NCGC00015067-05 |
| NCGC00015067-06 |
| NCGC00015067-07 |
| NCGC00015067-08 |
| NCGC00015067-09 |
| NCGC00015067-10 |
| NCGC00015067-11 |
| NCGC00015067-12 |
| NCGC00015067-13 |
| NCGC00015067-14 |
| NCGC00090977-01 |
| NCGC00090977-02 |
| NCGC00090977-03 |
| NCGC00090977-04 |
| NCGC00090977-05 |
| NCGC00090977-06 |
| NCGC00090977-07 |
| NCGC00254034-01 |
| NCGC00259666-01 |
| NCGC00260723-01 |
| NCI60_002222 |
| Neuronika |
| NINDS_000555 |
| Novid |
| NSC 27223 |
| NSC-27223 |
| NSC-406186 |
| NSC-755899 |
| NSC27223 |
| NSC406186 |
| NSC755899 |
| Nu-seals |
| Nu-seals aspirin |
| o-(Acetyloxy)benzoate |
| o-(Acetyloxy)benzoic acid |
| O-accetylsalicylic acid |
| o-Acetoxybenzoate |
| o-Acetoxybenzoic acid |
| O-Acetylsalicylic acid |
| O-Acetylsalicylic acid; Aspirin |
| o-Carboxyphenyl acetate |
| OR045489 |
| OR108792 |
| OR197645 |
| OR275198 |
| OR382102 |
| Percodan (Salt/Mix) |
| Percodan Demi (Salt/Mix) |
| Persistin |
| Pharmacin |
| Pharmakon1600-01500130 |
| Pirseal |
| PL-2200 |
| Polopirin |
| Polopiryna |
| Pravigard |
| Pravigard PAC (Salt/Mix) |
| Premaspin |
| PubChem20190 |
| R16CO5Y76E |
| Rheumin tabletten |
| Rheumintabletten |
| Rhodine |
| Rhonal |
| Ronal |
| RTX-012224 |
| S-211 |
| s3017 |
| Salacetin |
| Salcetogen |
| Saletin |
| Salicylic acid acetate |
| Salicylic acid, acetate |
| Salicylic acid, acetyl- |
| Salospir |
| Salycylacetylsalicylic acid |
| SBB015069 |
| SBI-0050027.P004 |
| SC-18564 |
| SC-61857 |
| SCHEMBL1353 |
| SMR000059138 |
| Solfrin |
| Solprin |
| Solprin acid |
| Solpyron |
| Solupsan |
| Soma Compound (Salt/Mix) |
| SP 189 |
| SPBio_001838 |
| Spectrum_001245 |
| SPECTRUM1500130 |
| Spectrum2_001899 |
| Spectrum3_001295 |
| Spectrum4_000099 |
| Spectrum5_000740 |
| Spira-Dine |
| SR-01000075668 |
| SR-01000075668-1 |
| St. Joseph |
| St. Joseph Aspirin for Adults |
| ST075414 |
| STL137674 |
| Supac |
| Tasprin |
| Temperal |
| Toldex |
| Tox21_110076 |
| Tox21_110076_1 |
| Tox21_202117 |
| Tox21_300146 |
| Tox21_500038 |
| Triaminicin |
| Triple-sal |
| UNII-R16CO5Y76E |
| UNM-0000306102 |
| WLN: QVR BOV1 |
| XAXA |
| Yasta |
| Z234893989 |
| ZINC53 |
| ZORprin |
US Patents and Regulatory Information for aspirin
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Novast Labs Ltd | CARISOPRODOL AND ASPIRIN | aspirin; carisoprodol | TABLET;ORAL | 040832-001 | Jan 7, 2010 | AB | RX | No | No | ➤ Try a Free Trial | ➤ Try a Free Trial | ➤ Try a Free Trial | |||
| Xanodyne Pharm | DARVON COMPOUND-65 | aspirin; caffeine; propoxyphene hydrochloride | CAPSULE;ORAL | 010996-007 | Mar 8, 1983 | DISCN | No | No | ➤ Try a Free Trial | ➤ Try a Free Trial | ➤ Try a Free Trial | ||||
| Bayer | MEASURIN | aspirin | TABLET, EXTENDED RELEASE;ORAL | 016030-002 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ➤ Try a Free Trial | ➤ Try a Free Trial | ➤ Try a Free Trial | ||||
| Sun Pharm Industries | SYNALGOS-DC | aspirin; caffeine; dihydrocodeine bitartrate | CAPSULE;ORAL | 011483-004 | Sep 6, 1983 | RX | Yes | Yes | ➤ Try a Free Trial | ➤ Try a Free Trial | ➤ Try a Free Trial | ||||
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
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Non-Orange Book US Patents for aspirin
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration |
|---|---|---|
| 8,911,752 | Methods of making compositions comprising lecithin oils and NSAIDS for protecting the gastrointestinal tract and providing enhanced therapeutic activity | ➤ Try a Free Trial |
| 9,687,551 | Compositions comprising lecithin oils and NSAIDs for protecting the gastrointestinal tract and providing enhanced therapeutic activity | ➤ Try a Free Trial |
| 9,730,884 | pH dependent carriers for targeted release of pharmaceuticals along the gastrointestinal tract, compositions therefrom, and making and using same | ➤ Try a Free Trial |
| Patent No. | Title | Estimated Patent Expiration |
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International Patents for aspirin
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Denmark | 1343529 | ➤ Try a Free Trial |
| Japan | 2010031044 | ➤ Try a Free Trial |
| Canada | 2431606 | ➤ Try a Free Trial |
| South Korea | 20030072565 | ➤ Try a Free Trial |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for aspirin
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 12/048 | Ireland | ➤ Try a Free Trial | PRODUCT NAME: A COMBINATION PRODUCT COMPRISING ASPIRIN AND ESOMEPRAZOLE MAGNESIUM TRIHYDRATE; NAT REGISTRATION NO/DATE: PA 970/063/001 20120831; FIRST REGISTRATION NO/DATE: 5402359; 5402367 5402375 20110812 |
| 2012000017 | Germany | ➤ Try a Free Trial | PRODUCT NAME: ASPIRIN UND ESOMEPRAZOL - MAGNESIUM-TRIHYDRAT; NAT. REGISTRATION NO/DATE: 81047.00.00 20110930 FIRST REGISTRATION: PORTUGAL 5402359 5402367 5402375 20110812 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
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