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Atropine sulfate - Generic Drug Details
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What are the generic sources for atropine sulfate and what is the scope of patent protection?
Atropine sulfate
is the generic ingredient in nineteen branded drugs marketed by Us Army, Akorn, Alcon Labs Inc, Hospira, Fresenius Kabi Usa, Sebela Ireland Ltd, Scherer Rp, Medpointe Pharm Hlc, West-ward Pharms Int, Alpharma Us Pharms, Gd Searle Llc, Md Pharm, Able, Ani Pharms Inc, Ascot, Bayshore Pharms Llc, Fosun Pharma, Heather, Hikma Pharms, Inwood Labs, Kv Pharm, Lannett, Lederle, Mylan, Par Pharm, Parke Davis, Pvt Form, R And S Pharma, Roxane, Sun Pharm Industries, Upsher Smith Labs, Usl Pharma, Valeant Pharm Intl, Watson Labs, Vangard, Superpharm, Halsey, Mylan Institutional, Abbvie, and Wyeth Ayerst, and is included in forty-six NDAs. Additional information is available in the individual branded drug profile pages.There are twenty-three drug master file entries for atropine sulfate. Nine suppliers are listed for this compound.
Summary for atropine sulfate
| US Patents: | 0 |
| Tradenames: | 19 |
| Applicants: | 40 |
| NDAs: | 46 |
| Drug Master File Entries: | 23 |
| Suppliers / Packagers: | 9 |
| Bulk Api Vendors: | 96 |
| Clinical Trials: | 24 |
| Patent Applications: | 6,259 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | atropine sulfate at DailyMed |
Recent Clinical Trials for atropine sulfate
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Sao Paulo General Hospital | N/A |
| Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | Phase 4 |
| Shanghai Eye Disease Prevention and Treatment Center | Phase 4 |
Pharmacology for atropine sulfate
| Drug Class | Anticholinergic Cholinergic Muscarinic Antagonist |
| Mechanism of Action | Cholinergic Antagonists Cholinergic Muscarinic Antagonists |
Synonyms for atropine sulfate
| (-)-Tropic Acid Ester with Tropine |
| (+-)-atropine |
| (+-)-hyoscyamine |
| (+,-)-Tropyl tropate |
| (+)-HYOSCYAMINE |
| (+/-)-Atropine |
| (+/-)-Hyoscyamine |
| (1beta,3alpha,5beta)-3-[(3-Hydroxy-1-oxo-2-phenylpropyl)oxy]-8-methyl-8-azabicyclo[3.2.1]octane |
| (1R,3r,5S)-8-methyl-8-azabicyclo[3.2.1]octan-3-yl 3-hydroxy-2-phenylpropanoate |
| (1S,5R)-8-methyl-8-azabicyclo[3.2.1]oct-3-yl 3-hydroxy-2-phenylpropanoate |
| (3-endo)-8-methyl-8-azabicyclo[3.2.1]oct-3-yl 3-hydroxy-2-phenylpropanoate |
| (3-endo)-8-methyl-8-azabicyclo[3.2.1]oct-3-yl tropate |
| (8-methyl-8-azabicyclo[3.2.1]octan-3-yl) 3-hydroxy-2-phenyl-propanoate; sulfuric acid |
| (8-methyl-8-azabicyclo[3.2.1]octan-3-yl) 3-hydroxy-2-phenylpropanoate; sulfuric acid |
| [(1R,5S)-8-methyl-8-azabicyclo[3.2.1]octan-3-yl] 3-hydroxy-2-phenyl-propanoate |
| [(1R,5S)-8-methyl-8-azabicyclo[3.2.1]octan-3-yl] 3-hydroxy-2-phenylpropanoate |
| [(1S,5R)-8-methyl-8-azabicyclo[3.2.1]oct-3-yl] 3-hydroxy-2-phenyl-propanoate |
| [(1S,5R)-8-methyl-8-azabicyclo[3.2.1]octan-3-yl] 3-hydroxy-2-phenyl-propanoate |
| 1-.alpha.-H, sulfate (2:1) salt |
| 1-alpha-H,5-alpha-H-Tropan-3-alpha-ol (+-)-tropate (ester) |
| 1-alpha-H,5-alpha-H-Tropan-3-alpha-ol (+-)-tropate (ester) (8CI) |
| 1-alpha-H,5-alpha-H-Tropan-3-alpha-ol (+-)-tropate (ester), sulfate (2:1) salt |
| 1.alpha.H, sulfate (2:1) (salt) |
| 13269-35-7 |
| 1445960-43-9 |
| 17108-73-5 |
| 1alphaH,5alphaH-Tropan-3alpha-ol (+-)-tropate (ester) |
| 1alphaH,5alphaH-Tropan-3alpha-ol (+-)-tropate (ester), sulfate (2:1) (salt) |
| 1alphaH,5alphaH-Tropan-3alpha-ol (+-)-tropate (ester), sulfate (2:1) (salt) (8CI) |
| 2-Phenylhydracrylic acid 3-alpha-tropanyl ester |
| 2C17H23NO3.H2O4S |
| 2C17H23NO3.H2SO4 |
| 3-tropoyloxytropane |
| 5093AF |
| 51-55-8 |
| 55-48-1 |
| 5908-99-6 |
| 620-61-1 |
| 78597-12-3 |
| 8-Methyl-8-azabicyclo[3.2.1]oct-3-yl 3-hydroxy-2-phenylpropanoate |
| 8-methyl-8-azabicyclo[3.2.1]oct-3-yl 3-hydroxy-2-phenylpropanoate sulfate(2:1) |
| 8-Methyl-8-azabicyclo[3.2.1]oct-3-yl tropate |
| 8-Methyl-8-azabicyclo[3.2.1]octan-3-yl 3-hydroxy-2-phenylpropionate |
| A 0257 |
| A0550 |
| AB00694549_14 |
| AB00694549-11 |
| AB00694549-12 |
| AC1L1LFL |
| AC1L29HW |
| AC1L5AX3 |
| AC1Q3XL2 |
| AC1Q6XFK |
| ACon1_000046 |
| AI3-14072 |
| AI3-60219 |
| AKOS015955538 |
| AKOS025397239 |
| AKOS026749880 |
| AKOS027326511 |
| alpha-(Hydroxymethyl)benzeneacetic acid 8-methyl-8-azabicyclo(3.2.1)oct-3-yl ester |
| alpha-Hydroxymethylphenylacetic acid (1R,5S)-8-methyl-8-azabicyclo[3.2.1]octane-3-yl ester |
| AN-41671 |
| AN-46690 |
| Anaspaz |
| AS-35261 |
| Atropair |
| Atropen |
| Atropen (TN) |
| Atropette |
| Atropin |
| Atropin [German] |
| Atropin siran |
| Atropin siran [Czech] |
| Atropin-flexiolen |
| Atropina |
| Atropina [Italian] |
| ATROPINE |
| Atropine (sulfate) |
| Atropine (USP) |
| Atropine [BAN] |
| Atropine [USP:BAN] |
| Atropine Care |
| Atropine for peak identification, European Pharmacopoeia (EP) Reference Standard |
| Atropine Sulfate (anhydrous) |
| Atropine sulfate (VAN) |
| Atropine sulfate anhydrous |
| Atropine sulfate anhydrous (2:1) salt |
| Atropine Sulfate Ansyr Plastic Syringe |
| Atropine sulfate monohydrate |
| Atropine Sulfate S.O.P. |
| Atropine Sulfate, Atropa belladonna L. |
| Atropine sulphate |
| Atropine sulphate (VAN) |
| Atropine, >=95.0% (NT) |
| Atropine, >=99% (TLC), powder |
| Atropine, analytical standard |
| Atropine, European Pharmacopoeia (EP) Reference Standard |
| Atropine, meets USP testing specifications |
| Atropine, sulfate (2:1) |
| Atropinium sulfate |
| Atropinol |
| Atropinsal |
| Atropinsulfat |
| Atropinsulfat [German] |
| Atropinum |
| Atropiny siarczan |
| Atropiny siarczan [Polish] |
| Atropisal |
| Atropisol |
| Atropt |
| Atrosulf |
| b eta-(Hydroxymethyl)benzeneacetic acid 8-methyl-8-azabicyclo[3.2.1]oct-3-yl ester |
| BCP13907 |
| BCP15060 |
| BDBM200229 |
| BDBM50403547 |
| Belladenal |
| Benzeneacetic acid, alpha-(hydroxymethyl)- (3-endo)-8-methyl-8-azabicyclo(3.2.1)oct-3-yl ester |
| Benzeneacetic acid, alpha-(hydroxymethyl)- (3-endo)-8-methyl-8-azabicyclo(3.2.1)oct-3-yl ester, sulfate (2:1) |
| Benzeneacetic acid, alpha-(hydroxymethyl)- (3-endo)-8-methyl-8-azabicyclo(3.2.1)oct-3-yl ester, sulfate (2:1) (salt) |
| Benzeneacetic acid, alpha-(hydroxymethyl)- 8-methyl-8-azabicyclo(3.2.1)oct-3-yl ester endo-(+-)- |
| Benzeneacetic acid, alpha-(hydroxymethyl)-, (3-endo)-8-methyl-8-azabicyclo(3.2.1)oct-3-yl ester |
| Benzeneacetic acid, alpha-(hydroxymethyl)-, (3-endo)-8-methyl-8-azabicyclo(3.2.1)oct-3-yl ester, sulfate (2:1) (salt) |
| Benzeneacetic acid, alpha-(hydroxymethyl)-, 8-methyl-8-azabicyclo(3.2.1)oct-3-yl ester, endo-(+-)- |
| Benzeneacetic acid, alpha-(hydroxymethyl)-, 8-methyl-8-azabicyclo(3.2.1)oct-3-yl ester, endo-(+-)-, sulfate (2:1) (salt) |
| Benzeneacetic acid, alpha-(hydroxymethyl)-, 8-methyl-8-azabicyclo(3.2.1)oct-3-yl ester, endo-(+/-)- |
| Benzeneacetic acid, alpha-(hydroxymethyl)-8-methyl-8-azabicyclo [3.2.1]oct-3-yl ester, endo-(+/-)- |
| Benzeneacetic acid, alpha-(hydroxymethyl)-8-methyl-8-azabicyclo(3,2,1)oct-3-yl ester, endo-(+-)- |
| Benzeneacetic acid, alpha-(hydroxymethyl)-8-methyl-8-azabicyclo(3.2.1)oct-3-yl ester, endo-(+-)- |
| Benzeneacetic acid, alpha-(hydroxymethyl)-8-methyl-8-azabicyclo[3.2.1]oct-3-yl ester endo-(+-)- |
| Benzeneacetic acid, sulfate (2:1) (salt) |
| beta-Phenyl-gamma-oxypropionsaeure-tropyl-ester |
| beta-Phenyl-gamma-oxypropionsaeure-tropyl-ester [German] |
| beta-Phenyl-gamma-oxypropionsaure-tropyl-ester |
| beta-Phenyl-gamma-oxypropionsaure-tropyl-ester [German] |
| bmse000649 |
| BRD-A27290375-001-01-8 |
| BRD-A27290375-330-01-1 |
| C01479 |
| C1504 |
| C17H23NO3 |
| CAS-51-55-8 |
| CAS-55-48-1 |
| CCG-221346 |
| CCG-38370 |
| CCRIS 3080 |
| CHEBI:16684 |
| CHEBI:78734 |
| CHEMBL1396281 |
| CHEMBL1607275 |
| CHEMBL3185794 |
| CHEMBL475124 |
| CHEMBL517712 |
| cid_174174 |
| component of Bar-Tropin |
| component of Enuretrol |
| component of Isopto Atropine |
| component of Lomotil |
| component of Motofen |
| Corbella |
| CPD001906768 |
| CS-4834 |
| CTK5A3690 |
| CTK5A9422 |
| Cytospaz |
| D00113 |
| Davurtrop |
| DB00572 |
| dl-Hyoscyamine |
| DL-Tropanyl 2-hydroxy-1-phenylpropionate |
| DL-Tropanyl 2-hydroxy-1-phenylpropionate sulfate |
| DL-Tropyl tropate |
| dl-Tropyltropate |
| Donnagel |
| DSSTox_CID_113 |
| DSSTox_CID_29379 |
| DSSTox_GSID_20113 |
| DSSTox_GSID_49419 |
| DSSTox_RID_75375 |
| DSSTox_RID_83494 |
| DTXSID3049419 |
| DTXSID4020113 |
| EINECS 200-104-8 |
| EINECS 200-235-0 |
| endo-( inverted exclamation markA)-|A-(Hydroxymethyl)benzeneacetic acid 8-methyl-8-azabicyclo[3.2.1]oct-3-yl ester |
| endo-(+/-)-alpha-(Hydroxymethyl)benzeneacetic acid 8-methyl-8-azabicyclo[3.2.1]oct-3-yl ester |
| ENDO-ATROPINE SULFATE |
| EU-0100042 |
| Eyesule |
| Eyesules |
| FT-0602865 |
| FT-0627165 |
| FT-0696350 |
| GP2470 |
| GTPL320 |
| HMS1920E15 |
| HMS2089A16 |
| HMS2091K15 |
| HMS2231G17 |
| HMS3259M13 |
| HMS3260I05 |
| HMS501L20 |
| HSDB 2199 |
| HY-B1205 |
| hyoscyamine |
| Hyoscyamine sulfate |
| Hyoscyamine sulfate hydrate |
| I-Tropine |
| Ichtho-bellol |
| Isopto Atropine |
| Isopto-atropine |
| L-Hyoscyamine |
| L-HYOSCYAMINE SULFATE |
| Lio-atropin |
| LP00042 |
| LS-22223 |
| LS-22224 |
| LS-7203 |
| MEGxp0_001878 |
| MFCD00022622 |
| Minims |
| Minims Atropine |
| MLS000069795 |
| MLS001148094 |
| MLS002695888 |
| MolPort-001-742-593 |
| MolPort-006-069-165 |
| Mydriasine |
| NC00493 |
| NCGC00017333-02 |
| NCGC00017333-03 |
| NCGC00017333-04 |
| NCGC00017333-05 |
| NCGC00017333-06 |
| NCGC00093557-01 |
| NCGC00094592-01 |
| NCGC00094592-02 |
| NCGC00094592-03 |
| NCGC00142514-01 |
| NCGC00142514-03 |
| NCGC00159345-02 |
| NCGC00258041-01 |
| NCGC00260392-01 |
| NCGC00260727-01 |
| NCGC00385525-01 |
| Neo-Diophen |
| NSC 26671 |
| NSC-26671 |
| NSC-755889 |
| NSC26671 |
| NSC755889 |
| Ocu-Tropine |
| Opera_ID_1088 |
| Pharmakon1600-01500131 |
| Protamine & Atropine |
| rac-(3-endo)-8-methyl-8-azabicyclo[3.2.1]oct-3-yl 3-hydroxy-2-phenylpropanoate |
| rac-tropan-3alpha-yl 3-hydroxy-2-phenylpropanoate |
| RKUNBYITZUJHSG-SPUOUPEWSA-N |
| RL00080 |
| ropine tropate |
| RTR-031981 |
| Ryuato |
| SAM002554885 |
| SBB005985 |
| SC-19284 |
| SCHEMBL1411666 |
| SCHEMBL14973972 |
| SCHEMBL2812 |
| SCHEMBL31133 |
| SMR000058248 |
| SPECTRUM1500131 |
| SR-01000075162-11 |
| SR-01000075162-5 |
| ST057178 |
| Sulfate d'atropine |
| Sulfate d'atropine [French] |
| Sulfatropinol |
| Tox21_110816 |
| Tox21_111590 |
| Tox21_200487 |
| Tox21_202846 |
| Tox21_500042 |
| TR-000361 |
| tropan-3alpha-yl 3-hydroxy-2-phenylpropanoate |
| Tropic acid, 3-alpha-tropanyl ester |
| Tropic acid, ester with tropine |
| Tropine (+/-)-tropate |
| Tropine tropate |
| Tropine, tropate (ester) |
| Tropintran |
| Troyl tropate |
| Urised |
| W-105053 |
| WLN: T56 A ANTJ A GOVYR&1Q & 2 &.H2.S-O4.QH |
US Patents and Regulatory Information for atropine sulfate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Abbvie | ATROPINE AND DEMEROL | atropine sulfate; meperidine hydrochloride | INJECTABLE;INJECTION | 087853-001 | Nov 26, 1982 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Parke Davis | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | atropine sulfate; diphenoxylate hydrochloride | TABLET;ORAL | 087131-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Sun Pharm Industries | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | atropine sulfate; diphenoxylate hydrochloride | TABLET;ORAL | 085506-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Watson Labs | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | atropine sulfate; diphenoxylate hydrochloride | TABLET;ORAL | 085876-001 | Approved Prior to Jan 1, 1982 | 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 |
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Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2019, www.DrugPatentWatch.com.