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Ibuprofen - Generic Drug Details
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What are the generic sources for ibuprofen and what is the scope of patent protection?
Ibuprofen
is the generic ingredient in forty-four branded drugs marketed by Pfizer, Amneal Pharms, Ascent Pharms Inc, Aurobindo Pharma Ltd, Bionpharma Inc, Contract Pharmacal, Humanwell Puracap, Marksans Pharma, P And L Dev Llc, Sofgen Pharms, Strides Pharma, Bayer, Cumberland Pharms, J And J Consumer Inc, Guardian Drug, L Perrigo Co, Tris Pharma Inc, Mcneil, Wyeth Cons, Moberg Pharma North, Perrigo, Abbott, Actavis Mid Atlantic, Aptapharma Inc, Arise, Hi Tech, P And L, Taro, Mcneil Consumer, Mcneil Ped, Lederle, Basf, Alra, Pliva, Amneal Pharms Ny, Ani Pharms Inc, Aurolife Pharma Llc, Avema Pharma, Dr Reddys La, Dr Reddys Labs Inc, Granules India, Granules India Ltd, Halsey, Hec Pharm, Ivax Sub Teva Pharms, Leiner, LNK, Merro Pharm, Mylan, Northstar Hlthcare, OHM, Ohm Labs, Par Pharm, Perrigo Pharms Co, Perrigo R And D, Purepac Pharm, Sandoz, Shandong Xinhua, Sun Pharm Industries, Superpharm, Teva, Vintage Pharms, Watson Labs, Bristol Myers, X-gen Pharms Inc, Recordati Rare, Pfizer Cons Hlthcare, Forest Labs, Actavis Elizabeth, Barr Labs Inc, and Dr Reddys Labs Ltd, and is included in two hundred and fifteen NDAs. There are fifteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.Ibuprofen has sixty-one patent family members in eighteen countries.
There are sixty-four drug master file entries for ibuprofen. Two hundred and fifty-five suppliers are listed for this compound.
Summary for ibuprofen
| International Patents: | 61 |
| US Patents: | 15 |
| Tradenames: | 44 |
| Applicants: | 71 |
| NDAs: | 215 |
| Drug Master File Entries: | 64 |
| Suppliers / Packagers: | 255 |
| Bulk Api Vendors: | 153 |
| Clinical Trials: | 640 |
| Patent Applications: | 8,840 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price trends for ibuprofen |
| Drug Sales Revenues: | Drug sales revenues for ibuprofen |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ibuprofen |
| DailyMed Link: | ibuprofen at DailyMed |
Recent Clinical Trials for ibuprofen
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Walter Reed National Military Medical Center | Phase 3 |
| Northwestern University | Phase 4 |
| Praxair Distribution, Inc. | Phase 2/Phase 3 |
Pharmacology for ibuprofen
| Drug Class | Nonsteroidal Anti-inflammatory Drug |
| Mechanism of Action | Cyclooxygenase Inhibitors |
Medical Subject Heading (MeSH) Categories for ibuprofen
Synonyms for ibuprofen
| .alpha.-(4-Isobutylphenyl)propionic acid |
| .alpha.-(p-isobutylphenyl)propionic acid |
| .alpha.-2-(p-Isobutylphenyl)propionic acid |
| .alpha.-Methyl-4-(2-methylpropyl)benzeneacetic acid |
| ( inverted exclamation markA)-Ibuprofen |
| ( inverted question mark)-Ibuprofen |
| (? inverted exclamation markA)-2-(4-Isobutylphenyl)Propanoic Acid |
| (?)-Ibuprofen |
| (.+-.)-2-(p-Isobutylphenyl)propionic acid |
| (.+-.)-p-Isobutylhydratropic acid |
| (.+/-.)-2-(p-Isobutylphenyl)propionic acid |
| (.+/-.)-p-Isobutylhydratropic acid |
| (+-)-2-(p-Isobutylphenyl)propionic acid |
| (+-)-alpha-Methyl-4-(2-methylpropyl)benzeneacetic acid |
| (+-)-Ibuprofen |
| (+-)-Ibuprophen |
| (+-)-p-Isobutylhydratropic acid |
| (+) ibuprofen |
| (+/-)-2-(4-Isobutylphenyl)Propanoic Acid |
| (+/-)-2-(p-isobutylphenyl)propionic acid |
| (+/-)-alpha-methyl-4-(2-methylpropyl)benzeneacetic acid |
| (+/-)-Ibuprofen |
| (+/-)-p-Isobutylhydratropic acid |
| (2s)-2-[4-(2-methylpropyl)phenyl]propionic acid DEXIBUPROFEN (S)-(+)-2-(4-ISOBUTYLPHENYL)PROPIONIC ACID (S)-(+)-4-ISOBUTYL-ALPHA-ME |
| (4-Isobutylphenyl)-alpha-methylacetic acid |
| (A+/-)-Ibuprofen |
| (R)-Ibuprofen |
| (r/s)-alpha-methyl-4-isobutylphenylacetic acid |
| (RS)-2-(4-(2-Methylpropyl)phenyl)propanoic acid |
| (RS)-Ibuprofen |
| (S)-4-Isobutyl-alpha-methylphenylacetic acid |
| (y)-Ibuprofen |
| [(+/-)-2-(4-Isobutylphenyl)-propionic Acid |
| 139466-08-3 |
| 15687-27-1 |
| 2-(4-Isobutyl-phenyl)-propionic acid |
| 2-(4-isobutylphenyl) propanoic acid |
| 2-(4-isobutylphenyl) propionic acid |
| 2-(4-isobutylphenyl)-propionic acid |
| 2-(4-Isobutylphenyl)-propionic acid ; alpha-Methyl-4-(2-methylpropyl)benzeneacetic acid ; p-Isobutylhydratropic acid |
| 2-(4-isobutylphenyl)-propionoic acid |
| 2-(4-Isobutylphenyl)propanoic acid |
| 2-(4-Isobutylphenyl)propanoicAcid |
| 2-(4-ISOBUTYLPHENYL)PROPIONIC ACID |
| 2-(4'-isobutylphenyl)-propionic acid |
| 2-(4'-isobutylphenyl)propionic acid |
| 2-(p-Isobutylphenyl)propionic acid |
| 2-[4-(2-methylpropyl)phenyl]propanoic acid |
| 2-p-isobutylphenylpropionic acid |
| 31121-93-4 (hydrochloride salt) |
| 4-Isobutyl-.alpha.-methylphenylacetic acid |
| 4-Isobutyl-alpha-methylphenylacetic acid |
| 4-Isobutylhydratropic acid |
| 4-Isobutylphenyl)-.alpha.-methylacetic acid |
| 58560-75-1 |
| 687I271 |
| 79261-49-7 (potassium salt) |
| A831926 |
| AB00052020_18 |
| AB00052020_19 |
| AB00052020-16 |
| AB00052020-17 |
| AB1009266 |
| AC-11312 |
| AC1L1GGE |
| AC1Q1P84 |
| AC1Q1P85 |
| ACHES-N-PAIN |
| Acide (isobutyl-4 phenyl)-2 propionique |
| Acide (isobutyl-4-phenyl)-2 propionique |
| Acide (isobutyl-4-phenyl)-2 propionique [French] |
| ACMC-209df0 |
| ACMC-209ks2 |
| Act-3 |
| ACT03248 |
| Actiprofen |
| Adex 200 |
| Adran |
| Advil |
| Advil (TN) |
| Advil Cold & Sinus (Salt/Mix) |
| Advil Liqui-Gels |
| Advil migraine |
| Advil Migraine Liqui-Gels |
| Advil, Children's |
| AK-47272 |
| Ak+C2278tren |
| AKOS003237488 |
| AKOS016340658 |
| Aktren |
| Alaxan |
| ALBB-025647 |
| Algofen |
| Alivium |
| alpha-(4-isobutylphenyl)-propionic acid |
| alpha-(4-Isobutylphenyl)propionate |
| alpha-(4-Isobutylphenyl)propionic acid |
| alpha-(p-isobutylphenyl)-propionic acid |
| alpha-(p-isobutylphenyl)propionic acid |
| alpha-Methyl-4-(2-methylpropyl)benzeneacetic acid |
| alpha-Methyl-4-(isobutyl)phenylacetic acid |
| alpha-Methyl-4-[2-methylpropyl] benzeneacetic Acid |
| alpha-p-Isobutylphenylpropionate |
| alpha-p-Isobutylphenylpropionic acid |
| Am-Fam 400 |
| AM20060782 |
| Amelior |
| Amersol |
| Amibufen |
| AN-18584 |
| Anafen |
| Anco |
| Andran |
| Anflagen |
| Antagil |
| Antalfene |
| Antarene |
| Antiflam |
| ANW-21658 |
| Apo-Ibuprofen |
| Apsifen |
| Apsifen-F |
| ARONIS23835 |
| Artofen |
| Artril |
| Artril 300 |
| Balkaprofen |
| Bayer Select Pain Relief |
| BB 0258487 |
| BBL010660 |
| BCP10423 |
| BCP20325 |
| BCP25225 |
| BDBM50009859 |
| Benzeneacetic acid, .alpha.-methyl-4-(2-methylpropyl)- |
| Benzeneacetic acid, .alpha.-methyl-4-(2-methylpropyl), (.+/-.)- |
| Benzeneacetic acid, alpha-methyl-4-(2-methylpropyl)- |
| Benzeneacetic acid, alpha-methyl-4-(2-methylpropyl), (+-)- |
| Benzeneacetic acid, alpha-methyl-4-(2-methylpropyl), (+/-)- |
| Betaprofen |
| BIDD:GT0050 |
| Bloom |
| Bluton |
| BR-47272 |
| BRD-A17655518-001-02-0 |
| BRD-A17655518-001-12-9 |
| BRN 2049713 |
| Brofen |
| Brufanic |
| Brufen |
| Brufen 400 |
| Brufen Retard |
| Bruflam |
| Brufort |
| BSPBio_002170 |
| Buburone |
| Bufeno |
| Bufigen |
| Bukrefen |
| Bupron |
| Buracaps |
| Burana |
| Butacortelone |
| Butylenin |
| C01588 |
| C13H18O2 |
| Caldolor |
| Cambridge id 5152402 |
| Cap-Profen |
| Carol |
| CAS-15687-27-1 |
| CBMicro_005634 |
| CCG-38947 |
| CCRIS 3223 |
| CDT-ibuprofen |
| Cesra |
| CHEBI:5855 |
| CHEMBL521 |
| Children's Advil |
| CHILDREN'S ADVIL-FLAVORED |
| Children's Elixsure |
| Children's Elixsure IB |
| Children's Elixsure IB (Salt/Mix) |
| Children's Ibuprofen |
| Children's Motrin |
| Citalgan |
| Cobo |
| Codral |
| Codral Period Pain |
| Combiflam |
| Combunox (Salt/Mix) |
| CPD000058184 |
| CS-1931 |
| CTK3J2010 |
| Cunil |
| D00126 |
| Daiprophen |
| Dalsy |
| Dansida |
| DB01050 |
| Deep Relief |
| Dentigoa |
| Dibufen |
| Dignoflex |
| DivK1c_000887 |
| Dolgin |
| Dolgirid |
| Dolgit |
| Dolibu |
| Dolmaral |
| DOLO PUREN |
| Dolo-Dolgit |
| Dolocyl |
| Dolofen |
| Dolofen-F |
| Dolofin |
| Dolofort |
| Dologel |
| Dolomax |
| Doloren |
| Dolormin |
| Doltibil |
| Dolven |
| Donjust B |
| Dorival |
| Drin |
| DSSTox_CID_732 |
| DSSTox_GSID_20732 |
| DSSTox_RID_75759 |
| DTXSID5020732 |
| Duafen |
| Dularbuprofen |
| Duobrus |
| Dura-Ibu |
| duralbuprofen |
| Dysdolen |
| Easifon |
| Ebufac |
| EC 239-784-6 |
| EINECS 239-784-6 |
| Emflam |
| Emflam-200 |
| Epitope ID:139973 |
| Epobron |
| Eputex |
| Ergix |
| Esprenit |
| EU-0100691 |
| Exneural |
| Faspic |
| Femadon |
| Femafen |
| Femapirin |
| Femidol |
| Fenbid |
| Fenbid Spansule |
| Fendol |
| Fenspan |
| Fibraflex |
| FT-0601629 |
| FT-0655194 |
| Gelufene |
| Genpril |
| Gofen |
| Grefen |
| GTPL2713 |
| Gynofug |
| Haltran |
| HEFNNWSXXWATRW-UHFFFAOYSA- |
| HEFNNWSXXWATRW-UHFFFAOYSA-N |
| Hemagene Tailleur |
| HMS1920F15 |
| HMS2089P05 |
| HMS2091N03 |
| HMS2230N04 |
| HMS3259G05 |
| HMS3262K03 |
| HMS3372M09 |
| HMS3649M11 |
| HMS3651A15 |
| HMS502M09 |
| HSDB 3099 |
| HY-78131 |
| Hydratropic acid, p-isobutyl- |
| I 4883 |
| I01-7039 |
| I0415 |
| IB-100 |
| Ibol |
| Ibren |
| Ibu |
| Ibu-Attritin |
| Ibu-slo |
| Ibu-slow |
| Ibu-Tab |
| Ibu-Tab 200 |
| Ibubest |
| Ibubeta |
| Ibucasen |
| Ibudol |
| Ibudolor |
| Ibufen |
| Ibuflamar |
| Ibufug |
| Ibugel |
| Ibugen |
| Ibugesic |
| Ibuhexal |
| Ibulagic |
| Ibular |
| Ibulav |
| Ibuleve |
| Ibulgan |
| Ibumed |
| Ibumerck |
| Ibumetin |
| Ibup |
| Ibupirac |
| Ibupril |
| Ibuprin |
| Ibuprocin |
| Ibuprofen - Adooq Bioscience |
| Ibuprofen (Advil) |
| Ibuprofen (Dolgesic) |
| Ibuprofen (JP17/USP/INN) |
| Ibuprofen [USAN:BAN:INN:JAN] |
| Ibuprofen [USAN:USP:INN:BAN:JAN] |
| Ibuprofen 1.0 mg/ml in Methanol |
| Ibuprofen for peak identification, European Pharmacopoeia (EP) Reference Standard |
| Ibuprofen I.V. Solution |
| IBUPROFEN USP GRADE |
| Ibuprofen-Zinc |
| Ibuprofen, >=98% (GC) |
| Ibuprofen, 99% |
| Ibuprofen, British Pharmacopoeia (BP) Reference Standard |
| Ibuprofen, European Pharmacopoeia (EP) Reference Standard |
| Ibuprofen, meets USP testing specifications |
| Ibuprofen, Pharmaceutical Secondary Standard; Certified Reference Material |
| Ibuprofen, United States Pharmacopeia (USP) Reference Standard |
| Ibuprofen, Vetec(TM) reagent grade, 97% |
| Ibuprofen, VETRANAL(TM), analytical standard |
| Ibuprofen,(S) |
| Ibuprofene |
| Ibuprofene [INN-French] |
| Ibuprofeno |
| Ibuprofeno [INN-Spanish] |
| Ibuprofenum |
| Ibuprofenum [INN-Latin] |
| Ibuprohm |
| Ibuprophen |
| Ibuprox |
| Ibusal |
| Ibutid |
| Ibux |
| IDI1_000887 |
| Ifen |
| Inabrin |
| InChI=1/C13H18O2/c1-9(2)8-11-4-6-12(7-5-11)10(3)13(14)15/h4-7,9-10H,8H2,1-3H3,(H,14,15) |
| Inflam |
| Inoven |
| IP-82 |
| Ipren |
| Irfen |
| Isobutylpropanoicphenolic acid |
| Isodol |
| J-009349 |
| J10135 |
| Jenaprofen |
| Junifen |
| Junior Strength Advil |
| Junior Strength Ibuprofen |
| Junior Strength Motrin |
| KB-222912 |
| KBio1_000887 |
| KBio2_001329 |
| KBio2_003897 |
| KBio2_006465 |
| KBio3_001390 |
| KBioGR_000389 |
| KBioSS_001329 |
| Kesan |
| Kontagripp Mono |
| Kratalgin |
| KS-00000CJ0 |
| KS-000047NV |
| KS-5029 |
| KSC492A1B |
| Lamidon |
| Lebrufen |
| Librofem |
| Lidifen |
| Liptan |
| Lopac0_000691 |
| Lopane |
| LP00691 |
| LS-7454 |
| M-4957 |
| Malafene |
| Manypren |
| MCULE-9475454445 |
| Medipren |
| Melfen |
| Mensoton |
| MFCD00010393 |
| Midol |
| Midol 200 |
| Midol IB Cramp Relief |
| Midol Liquid Gels |
| MLS000069733 |
| MLS001146965 |
| MolPort-001-791-802 |
| Moment |
| Motrin |
| Motrin (TN) |
| Motrin IB |
| Motrin IB Gelcaps |
| Motrin IB Gelcaps (Salt/Mix) |
| MOTRIN MIGRAINE PAIN |
| Mynosedin |
| N4,N4' -Di(naphthalen-1-yl)-N4,N4' -bis(4-vinylphenyl)biphenyl-4,4'-diamine |
| Nagifen-D |
| Napacetin |
| Narfen |
| NC00458 |
| NCGC00015529-04 |
| NCGC00015529-05 |
| NCGC00015529-06 |
| NCGC00015529-07 |
| NCGC00015529-08 |
| NCGC00015529-09 |
| NCGC00015529-10 |
| NCGC00015529-12 |
| NCGC00015529-13 |
| NCGC00015529-14 |
| NCGC00015529-15 |
| NCGC00015529-18 |
| NCGC00089819-02 |
| NCGC00089819-03 |
| NCGC00089819-04 |
| NCGC00089819-05 |
| NCGC00089819-06 |
| NCGC00089819-07 |
| NCGC00256416-01 |
| NCGC00258935-01 |
| NCGC00261376-01 |
| NCI60_002065 |
| Neo-Helvagit |
| Neo-Mindol |
| Neobrufen |
| Nerofen |
| NINDS_000887 |
| Noalgil |
| Nobafon |
| Nobfelon |
| Nobfen |
| Nobgen |
| Noritis |
| Novadol |
| Novo Dioxadol |
| Novo-Profen |
| Novogent |
| Novogent N |
| Novoprofen |
| NSC 256857 |
| NSC-256857 |
| NSC-757073 |
| NSC256857 |
| NSC757073 |
| Nuprilan |
| Nuprin |
| Nurofen |
| Nurofen Meltlets |
| Opera_ID_554 |
| Optifen |
| Opturem |
| Oralfene |
| Ostarin |
| Ostofen |
| Ozonol |
| p-Isobutyl-2-phenylpropionate |
| p-Isobutyl-2-phenylpropionic acid |
| p-isobutyl-hydratropic acid |
| p-Isobutylhydratropate |
| p-Isobutylhydratropic acid |
| Paduden |
| Panafen |
| Pantrop |
| Para-Isobutylhydratropic Acid |
| Paxofen |
| Pedea |
| Pedia-Profen |
| PediaProfen |
| Pediatric Advil |
| Perofen |
| Perrigo ibuprofen |
| Pharmakon1600-01500347 |
| Proartinal |
| Profen |
| Proflex |
| Propanoic acid, 2-(4-isobutylphenyl) |
| Provon |
| PubChem16054 |
| Quadrax |
| R.D. 13621 |
| Racemic ibuprofen |
| Rafen |
| Ranofen |
| RD 13621 |
| Rebugen |
| Relcofen |
| Rhinadvil |
| Rofen |
| Roidenin |
| RP26239 |
| RTR-006580 |
| Rufen |
| Rufin |
| Rupan |
| s1638 |
| Sadefen |
| Salivia |
| Salprofen |
| SAM002264619 |
| SB19113 |
| SBB064160 |
| SBI-0050669.P004 |
| SC-18867 |
| SCHEMBL3001 |
| Schmerz-Dolgit |
| Seclodin |
| Sednafen |
| Seklodin |
| Seskafen |
| Sine-Aid IB Caplets (Salt/Mix) |
| Siyafen |
| SMR000058184 |
| Solpaflex |
| Solufen |
| SPBio_000178 |
| Spectrum_000849 |
| SPECTRUM1500347 |
| Spectrum2_000129 |
| Spectrum3_000465 |
| Spectrum4_000015 |
| Spectrum5_000862 |
| SR-01000000214 |
| SR-01000000214-13 |
| SR-01000000214-2 |
| SR-01000000214-4 |
| ST-1482 |
| ST024750 |
| ST24032335 |
| Stelar |
| STK177358 |
| Sugafen |
| Suprafen |
| Suspren |
| SW203738-2 |
| Syntofene |
| Tab-Profen |
| Tabalon |
| Tabalon 400 |
| Tatanal |
| Tempil |
| TL8001184 |
| Tofen |
| Togal N |
| Tonal |
| Tox21_110170 |
| Tox21_110170_1 |
| Tox21_201384 |
| Tox21_302829 |
| Tox21_500691 |
| TR-006580 |
| TRA0047278 |
| Trauma-Dolgit Gel |
| Trendar |
| U 18573 |
| U-18,573 |
| U-18573 |
| UCB 79171 |
| Unipron |
| Upfen |
| Uprofen |
| Urem |
| VUFB 9649 |
| WLN: QVY&R DIY |
| Z1695709473 |
| Zafen |
| ZAG-1701 |
| Zofen |
Paragraph IV (Patent) Challenges for IBUPROFEN
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| CHILDREN'S MOTRIN | TABLET, CHEWABLE;ORAL | ibuprofen | 020601 | |
| JUNIOR STRENGTH MOTRIN | TABLET, CHEWABLE;ORAL | ibuprofen | 020601 | |
| CHILDREN'S MOTRIN | SUSPENSION/DROPS;ORAL | ibuprofen | 020603 |
US Patents and Regulatory Information for ibuprofen
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pfizer | ADVIL | ibuprofen | TABLET;ORAL | 018989-001 | May 18, 1984 | OTC | No | No | Start Trial | Start Trial | Start Trial | ||||
| Mcneil Ped | MOTRIN | ibuprofen | TABLET, CHEWABLE;ORAL | 020135-001 | Nov 16, 1994 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Par Pharm | IBUPROFEN | ibuprofen | TABLET;ORAL | 070328-001 | Aug 6, 1985 | DISCN | No | No | Start Trial | Start Trial | Start 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 ibuprofen
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| J And J Consumer Inc | CHILDREN'S MOTRIN | ibuprofen | TABLET, CHEWABLE;ORAL | 020601-001 | Nov 15, 1996 | Start Trial | Start Trial |
| Mcneil Ped | MOTRIN | ibuprofen | TABLET, CHEWABLE;ORAL | 020135-002 | Nov 16, 1994 | Start Trial | Start Trial |
| Bionpharma Inc | MIDOL LIQUID GELS | ibuprofen | CAPSULE;ORAL | 021472-001 | Oct 18, 2002 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ibuprofen
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Australia | 2009350474 | Start Trial |
| Canada | 2754922 | Start Trial |
| European Patent Office | 2453742 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
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Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2019, www.DrugPatentWatch.com.