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MORPHABOND ER Drug Profile
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See Plans and PricingWhen do Morphabond Er patents expire, and when can generic versions of Morphabond Er launch?
Morphabond Er is a drug marketed by Daiichi Sankyo Inc and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.
This drug has twenty-three patent family members in ten countries.
The generic ingredient in MORPHABOND ER is morphine sulfate. There are twenty-three drug master file entries for this compound. Forty-four suppliers are listed for this compound. Additional details are available on the morphine sulfate profile page.
US ANDA Litigation and Generic Entry Outlook for Morphabond Er
A generic version of MORPHABOND ER was approved as morphine sulfate by HOSPIRA on May 11th, 1988.
Summary for MORPHABOND ER
| International Patents: | 23 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 18 |
| Patent Applications: | 2,934 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for MORPHABOND ER |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for MORPHABOND ER |
| DailyMed Link: | MORPHABOND ER at DailyMed |
Recent Litigation for MORPHABOND ER
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| INSPIRION DELIVERY SCIENCES, LLC v. TEVA PHARMACEUTICALS USA, INC. | 2019-04-19 |
Pharmacology for MORPHABOND ER
| Drug Class | Opioid Agonist |
| Mechanism of Action | Full Opioid Agonists |
Synonyms for MORPHABOND ER
| (4R,4aR,7S,7aR,12bS)-3-methyl-2,4,4a,7,7a,13-hexahydro-1H-4,12-methanobenzofuro[3,2-e]isoquinoline-7,9-diol;sulfuric acid;pentahydrate |
| (5alpha,6alpha)-7,8-didehydro-4,5-epoxy-17-methylmorphinan-3,6-diol, hydrogen sulfate (2:1) |
| 1095-53-0 |
| 17-methyl-7,8-didehydro-4,5alpha-epoxymorphinan-3,6-diol sulfate (2:1) |
| 17-methyl-7,8-didehydro-4,5alpha-epoxymorphinan-3,6-diol sulfate (2:1) pentahydrate |
| 178935-96-1 |
| 4,5-alpha-Epoxy-17-methylmorphinan-3,5-alpha-diol sulfate hydrate (2:1:5) |
| 57-27-2 (Parent) |
| 6211-15-0 |
| 64-31-3 |
| 66591-53-5 |
| 7,8-Didehydro-4,5alpha-epoxy-17-methylmorphinan-3,6alpha-diol sulfate (2:1) (salt) pentahydrate |
| 92004-19-8 |
| Apomorphine impurity B (morphine sulfate), European Pharmacopoeia (EP) Reference Standard |
| Arymo ER |
| Astramor PH (TN) |
| Astramorph |
| Astramorph PF |
| Avinza |
| Avinza (TN) |
| CAS-6211-15-0 |
| CHEBI:50731 |
| CHEBI:7003 |
| CHEMBL2096625 |
| CHEMBL2103744 |
| D00842 |
| Depodur (TN) |
| Di(morphine) dihydrogen sulfate pentahydrate |
| DSSTox_CID_28840 |
| DSSTox_GSID_48914 |
| DSSTox_RID_83109 |
| DTXSID1048914 |
| DTXSID4023830 |
| Duramorph |
| Duramorph PF |
| DY70C97N30 |
| EINECS 200-582-8 |
| Kadian (TN) |
| Kapanol |
| l-Morphine sulfate |
| Morphabond |
| Morphinan-3,6-alpha-diol, 7,8-didehydro-4, 5-alpha-epoxy-17-methyl-, sulfate |
| Morphinan-3,6-diol, 7,8-didehydro-4,5-epoxy-17-methyl- (5alpha,6alpha)-, sulfate (2:1) (salt) |
| Morphinan-3,6-diol, 7,8-didehydro-4,5-epoxy-17-methyl-(5-alpha,6-alpha)-, sulfate (2:1) (salt), pentahdrate |
| Morphinan-3,6-diol, 7,8-didehydro-4,5-epoxy-17-methyl, (5alpha,6alpha)-, sulfate (2:1) (salt), pentahydrate |
| Morphinan-3,6alpha-diol, 7,8-didehydro-4,5alpha-epoxy-17-methyl-, sulfate (2:1) (salt) |
| Morphinan-3,6alpha-diol, 7,8-didehydro-4,5lpha-epoxy-17-methyl-, sulfate (2:1) (salt), pentahydrate |
| Morphine Extra-Forte |
| Morphine for system suitability, European Pharmacopoeia (EP) Reference Standard |
| Morphine Forte |
| Morphine H.P |
| Morphine hemi[sulfate pentahydrate] |
| Morphine Hemisulfate Pentahemihydrate |
| Morphine Hemisulphate Pentahemihydrate |
| Morphine sulfat, European Pharmacopoeia (EP) Reference Standard |
| MORPHINE SULFATE |
| Morphine Sulfate (anhydrous) |
| Morphine sulfate (USP) |
| Morphine sulfate [USP:JAN] |
| Morphine sulfate hydrate |
| Morphine sulfate hydrate (JP17) |
| Morphine sulfate pentahydrate |
| Morphine sulfate salt pentahydrate |
| Morphine sulfate salt pentahydrate, analytical standard |
| Morphine sulfate salt solution |
| Morphine sulfate salt solution, 1.0 mg/mL in methanol, drug standard |
| Morphine sulfate, United States Pharmacopeia (USP) Reference Standard |
| Morphine sulphate |
| Morphine sulphate (2:1) |
| Morphine sulphate pentahydrate |
| Morphine, hemisulfate |
| MS contin (TN) |
| MST-1 Continus |
| NCGC00247707-01 |
| NIH 0001 |
| NIH 10753 |
| NSC 11441 |
| Oramorph SR |
| SCHEMBL29316 |
| Skenan |
| Tox21_112861 |
| UNII-DY70C97N30 |
| UNII-X3P646A2J0 |
| X3P646A2J0 |
Paragraph IV (Patent) Challenges for MORPHABOND ER
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| MORPHABOND ER | TABLET, EXTENDED RELEASE;ORAL | morphine sulfate | 206544 | 2019-01-28 |
US Patents and Regulatory Information for MORPHABOND ER
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Daiichi Sankyo Inc | MORPHABOND ER | morphine sulfate | TABLET, EXTENDED RELEASE;ORAL | 206544-001 | Oct 2, 2015 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Daiichi Sankyo Inc | MORPHABOND ER | morphine sulfate | TABLET, EXTENDED RELEASE;ORAL | 206544-004 | Oct 2, 2015 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Daiichi Sankyo Inc | MORPHABOND ER | morphine sulfate | TABLET, EXTENDED RELEASE;ORAL | 206544-002 | Oct 2, 2015 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Daiichi Sankyo Inc | MORPHABOND ER | morphine sulfate | TABLET, EXTENDED RELEASE;ORAL | 206544-004 | Oct 2, 2015 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Daiichi Sankyo Inc | MORPHABOND ER | morphine sulfate | TABLET, EXTENDED RELEASE;ORAL | 206544-001 | Oct 2, 2015 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Daiichi Sankyo Inc | MORPHABOND ER | morphine sulfate | TABLET, EXTENDED RELEASE;ORAL | 206544-002 | Oct 2, 2015 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for MORPHABOND ER
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Poland | 2187873 | Start Trial |
| European Patent Office | 2187873 | Start Trial |
| China | 105534936 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2009023672 | Start Trial |
| Japan | 5965583 | Start Trial |
| Mexico | 2010001812 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
