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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, Barr, Impax Labs Inc, Par Pharm Inc, Sandoz Inc, Zydus Pharms Usa Inc, Schwarz Pharma, Abbott, Par Pharm, Medpointe Pharm Hlc, Mcneil, Robins Ah, Aralez Pharms, 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 nine 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:	9
Tradenames:	53
Applicants:	53
NDAs:	81
Drug Master File Entries:	21
Suppliers / Packagers:	1
Bulk Api Vendors:	93
Clinical Trials:	1,138
Patent Applications:	6,571
Formulation / Manufacturing:	see details
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

Anti-Inflammatory Agents, Non-Steroidal

Antipyretics

Cyclooxygenase Inhibitors

Fibrinolytic Agents

Platelet Aggregation Inhibitors

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
Sandoz	PROPOXYPHENE COMPOUND 65	aspirin; caffeine; propoxyphene hydrochloride	CAPSULE;ORAL	080044-002	Sep 16, 1983		DISCN	No	No
Aaipharma Llc	DARVON-N W/ ASA	aspirin; propoxyphene napsylate	CAPSULE;ORAL	016829-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Galt Pharms	ORPHENGESIC FORTE	aspirin; caffeine; orphenadrine citrate	TABLET;ORAL	075141-002	May 29, 1998		DISCN	No	No
Bristol Myers Squibb	PRAVIGARD PAC (COPACKAGED)	aspirin; pravastatin sodium	TABLET, TABLET;ORAL	021387-006	Jun 24, 2003		DISCN	No	No

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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
9,730,884	pH dependent carriers for targeted release of pharmaceuticals along the gastrointestinal tract, compositions therefrom, and making and using same
8,911,752	Methods of making compositions comprising lecithin oils and NSAIDS for protecting the gastrointestinal tract and providing enhanced therapeutic activity
9,687,551	Compositions comprising lecithin oils and NSAIDs for protecting the gastrointestinal tract and providing enhanced therapeutic activity

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International Patents for aspirin

Country	Document Number	Estimated Expiration
Germany	60136647
Japan	2005506303
Australia	2001297778
Japan	2014531460

Supplementary Protection Certificates for aspirin

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2012000017	Germany		PRODUCT NAME: ASPIRIN UND ESOMEPRAZOL - MAGNESIUM-TRIHYDRAT; NAT. REGISTRATION NO/DATE: 81047.00.00 20110930 FIRST REGISTRATION: PORTUGAL 5402359 5402367 5402375 20110812
12/048	Ireland		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