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RAZADYNE ER Drug Profile
When do Razadyne Er patents expire, and when can generic versions of Razadyne Er launch?
Razadyne Er is a drug marketed by Janssen Pharms and is included in one NDA. There is one patent protecting this drug and two Paragraph IV challenges.
This drug has forty-four patent family members in thirty-five countries.
The generic ingredient in RAZADYNE ER is galantamine hydrobromide. There are fifteen drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the galantamine hydrobromide profile page.
Summary for RAZADYNE ER
| International Patents: | 44 |
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 54 |
| Clinical Trials: | 18 |
| Patent Applications: | 4,110 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for RAZADYNE ER |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for RAZADYNE ER |
| DailyMed Link: | RAZADYNE ER at DailyMed |
Pharmacology for RAZADYNE ER
| Drug Class | Cholinesterase Inhibitor |
| Mechanism of Action | Cholinesterase Inhibitors |
Medical Subject Heading (MeSH) Categories for RAZADYNE ER
Synonyms for RAZADYNE ER
| (-)-Galantamine |
| (-)-Galanthamine |
| (+/-)-Galantamine |
| (+/-)-Galanthamine |
| (1S,12S,14R)-9-methoxy-4-methyl-11-oxa-4-azatetracyclo[8.6.1.0^{1,12}.0^{6,17}]heptadeca-6,8,10(17),15-tetraen-14-ol |
| (1S,12S,14R)-9-methoxy-4-methyl-11-oxa-4-azatetracyclo[8.6.1.0;{1,12}.0;{6,17}]heptadeca-6,8,10(17),15-tetraen-14-ol |
| (1S,12S,14R)-9-METHOXY-4-METHYL-11-OXA-4-AZATETRACYCLO[8.6.1.0(1),(1)(2).0?,(1)?]HEPTADECA-6,8,10(17),15-TETRAEN-14-OL |
| (1S,12S,14R)-9-METHOXY-4-METHYL-11-OXA-4-AZATETRACYCLO[8.6.1.0(1),(1)(2).0?,(1)?]HEPTADECA-6(17),7,9,15-TETRAEN-14-OL |
| (1S,12S,14R)-9-methoxy-4-methyl-11-oxa-4-azatetracyclo[8.6.1.01,12.06,17]heptadeca-6(17),7,9,15-tetraen-14-ol |
| (4aS,6R,8aS)-3-methoxy-11-methyl-4a,5,9,10,11,12-hexahydro-6H-benzo[2,3]benzofuro[4,3-cd]azepin-6-ol |
| (4aS,6R,8aS)-4a,5,9,10,11,12-Hexahydro-3-methoxy-11-methyl-6H-benzofuro(3a,3,2-ef)(2)benzazepin-6-ol |
| (4aS,6R,8aS)-4a,5,9,10,11,12-Hexahydro-3-methoxy-11-methyl-6H-benzofurol[3a,3,2,-ef][2]benzazepin-6-ol |
| 0D3Q044KCA |
| 1008759-59-8 |
| 1354-74-1 |
| 1551-02-6 |
| 1dx6 |
| 1qti |
| 23173-12-8 |
| 27501-22-0 |
| 357-70-0 |
| 357G700 |
| 4-27-00-02184 (Beilstein Handbook Reference) |
| 6H-Benzofuro(3a,3,2-ef)(2)benzazepin-6-ol, 4a,5,9,10,11,12-hexahydro-3-methoxy-11-methyl-, (4aalpha,6beta,8ar*)- |
| 6H-Benzofuro(3a,3,2-ef)(2)benzazepin-6-ol, 4a,5,9,10,11,12-hexahydro-3-methoxy-11-methyl-, (4aR,6S,8aR)-rel- |
| 6H-Benzofuro(3a,3,2-ef)(2)benzazepin-6-ol, 4a,5,9,10,11,12-hexahydro-3-methoxy-11-methyl-, (4aS,6R,8aS)- |
| 6H-Benzofuro[3a,3,2-ef][2]benzazepin-6-ol, 4a,5,9,10,11,12-hexahydro-3-methoxy-11-methyl-, (4aS,6R,8aS)- |
| 6H-Benzofuro[3a,3,2-ef][2]benzazepin-6-ol,4a,5,9,10,11,12-hexahydro-3-methoxy-11-methyl-, (4aS,6R,8aS)- |
| 736-79-8 |
| AB00053614_10 |
| AB00053614-09 |
| AC-20240 |
| AC1L1TIM |
| AJ-23165 |
| AK198672 |
| AKOS015965330 |
| AM62710 |
| AN-133 |
| AN-44509 |
| ASUTZQLVASHGKV-JDFRZJQESA- |
| ASUTZQLVASHGKV-JDFRZJQESA-N |
| BDBM10404 |
| BIDD:GT0517 |
| Bodamine |
| BPBio1_000480 |
| BRD-K49481516-004-03-5 |
| BRD-K49481516-004-04-3 |
| BRN 0093736 |
| BSPBio_000436 |
| BSPBio_003416 |
| C08526 |
| CAS-357-70-0 |
| CCG-212961 |
| CG0028 |
| CHEBI:42944 |
| CHEMBL659 |
| CS-1217 |
| CTK8F9985 |
| D04292 |
| D0R9VR |
| DB00674 |
| DivK1c_000590 |
| DR001054 |
| DSSTox_CID_25606 |
| DSSTox_GSID_45606 |
| DSSTox_RID_80999 |
| DTXSID2045606 |
| Galantamin |
| Galantamin(NSC 100058) |
| Galantamina |
| Galantamina [INN-Spanish] |
| Galantamine |
| Galantamine (USAN/INN) |
| Galantamine [USAN:INN:BAN] |
| Galantamine [USAN:INN] |
| Galantamine, (+/-)- |
| Galantaminum |
| Galantaminum [INN-Latin] |
| galanthamine |
| Galanthamine base |
| Galanthamine HBr |
| Galanthamine, (+/-)- |
| Galanthamine, 12 |
| Galanthaminum |
| GNT |
| GTPL6693 |
| HMS2089H03 |
| HSDB 7361 |
| HY-76299 |
| IDI1_000590 |
| InChI=1/C17H21NO3/c1-18-8-7-17-6-5-12(19)9-14(17)21-16-13(20-2)4-3-11(10-18)15(16)17/h3-6,12,14,19H,7-10H2,1-2H3/t12-,14-,17-/m0/s1 |
| Jilkon |
| KBio1_000590 |
| KBio2_001751 |
| KBio2_004319 |
| KBio2_006887 |
| KBio3_002636 |
| KBioGR_001417 |
| KBioSS_001751 |
| KS-000000IN |
| LS-71039 |
| Lycoremin |
| Lycoremine |
| MCULE-7156449246 |
| MCULE-7226205054 |
| MolPort-002-521-885 |
| NCGC00017256-04 |
| NCGC00017256-05 |
| NCGC00024731-02 |
| NINDS_000590 |
| Nivalin |
| Nivalin (TN) |
| NSC 100058 |
| NSC-759861 |
| NSC759861 |
| Pharmakon1600-01501202 |
| PL001680 |
| PL054958 |
| Prestwick0_000588 |
| Prestwick1_000588 |
| Prestwick2_000588 |
| Prestwick3_000588 |
| Probes1_000055 |
| Probes2_000395 |
| Razadyne |
| Razadyne (TN) |
| Razadyne ER (TN) |
| Reminyl |
| Reminyl (TN) |
| SBI-0051689.P002 |
| SCHEMBL2577 |
| SCHEMBL3293474 |
| SDCCGMLS-0066737.P001 |
| SMP1_000131 |
| SPBio_002655 |
| Spectrum_001271 |
| Spectrum3_001738 |
| Spectrum4_000839 |
| Spectrum5_001673 |
| STOCK1N-46108 |
| Tox21_110807 |
| UNII-0D3Q044KCA |
| UNII-1T835Z585R component ASUTZQLVASHGKV-JDFRZJQESA-N |
| W-5162 |
| ZINC491073 |
US Patents and Regulatory Information for RAZADYNE ER
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Janssen Pharms | RAZADYNE ER | galantamine hydrobromide | CAPSULE, EXTENDED RELEASE;ORAL | 021615-001 | Apr 1, 2005 | AB | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | ||
| Janssen Pharms | RAZADYNE ER | galantamine hydrobromide | CAPSULE, EXTENDED RELEASE;ORAL | 021615-002 | Apr 1, 2005 | AB | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | ||
| Janssen Pharms | RAZADYNE ER | galantamine hydrobromide | CAPSULE, EXTENDED RELEASE;ORAL | 021615-003 | Apr 1, 2005 | AB | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | Y | ➤ 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 RAZADYNE ER
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Janssen Pharms | RAZADYNE ER | galantamine hydrobromide | CAPSULE, EXTENDED RELEASE;ORAL | 021615-001 | Apr 1, 2005 | ➤ Sign Up | ➤ Sign Up |
| Janssen Pharms | RAZADYNE ER | galantamine hydrobromide | CAPSULE, EXTENDED RELEASE;ORAL | 021615-002 | Apr 1, 2005 | ➤ Sign Up | ➤ Sign Up |
| Janssen Pharms | RAZADYNE ER | galantamine hydrobromide | CAPSULE, EXTENDED RELEASE;ORAL | 021615-003 | Apr 1, 2005 | ➤ Sign Up | ➤ Sign Up |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
Paragraph IV (Patent) Challenges for RAZADYNE ER
| Drugname | Dosage | Strength | RLD | Date |
|---|---|---|---|---|
| ➤ Subscribe | Extended-release Capsules | 16 mg and 24 mg | ➤ Subscribe | ➤ Sign Up |
| ➤ Subscribe | Extended-release Capsules | 8 mg | ➤ Subscribe | ➤ Sign Up |
International Patents for RAZADYNE ER
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Japan | 2002533396 | ➤ Sign Up |
| Hungary | 0104778 | ➤ Sign Up |
| Bulgaria | 105564 | ➤ Sign Up |
| Poland | 349501 | ➤ Sign Up |
| Taiwan | I262079 | ➤ Sign Up |
| Norway | 20012857 | ➤ Sign Up |
| Australia | 2100600 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for RAZADYNE ER
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 00140 | Netherlands | ➤ Sign Up | PRODUCT NAME: GALANTAMINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZUURADDITIEZOUT, IN HET BIJZONDER GALANTAMINE HYDROBROMIDE; NAT. REGISTRATION NO/DATE: RVG 29073 - RVG 29076 20030702; FIRST REGISTRATION: SE 15561 - 15565 20000225 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
