MORPHINE SULFATE - Generic Drug Details
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What are the generic drug sources for morphine sulfate and what is the scope of patent protection?
Morphine sulfate
is the generic ingredient in fourteen branded drugs marketed by King Pharms Llc, Allergan, Actavis Elizabeth, Impax Labs Inc, Nortec Dev Assoc, Strides Pharma, Teva Pharms Usa, Upsher Smith Labs, Pacira Pharms Inc, Fresenius Kabi Usa, Hikma, Piramal Critical, Hospira, Hospira Inc, Icu Medical Inc, Intl Medication Sys, Specgx Llc, Watson Labs, Meridian Medcl Techn, Ani Pharms, Chartwell Molecular, Nostrum Labs Inc, Padagis Us, Pharm Assoc, Rhodes Pharms, Tris Pharma Inc, Vistapharm, Winder Labs Llc, Zyla, Ohemo Life, Dava Pharms Inc, Dr Reddys Labs Sa, Epic Pharma Llc, Nesher Pharms, Novel Labs Inc, Rising, Sun Pharm Inds Ltd, Sun Pharm Industries, Purdue Pharma Lp, Xanodyne Pharms Inc, Alkem Labs Ltd, Ingenus Pharms Nj, and Alpharma Pharms, and is included in seventy-six NDAs. There are sixteen patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Morphine sulfate has fifty-nine patent family members in sixteen countries.
There are twelve drug master file entries for morphine sulfate. Thirty suppliers are listed for this compound.
Summary for MORPHINE SULFATE
International Patents: | 59 |
US Patents: | 16 |
Tradenames: | 14 |
Applicants: | 43 |
NDAs: | 76 |
Drug Master File Entries: | 12 |
Finished Product Suppliers / Packagers: | 30 |
Raw Ingredient (Bulk) Api Vendors: | 24 |
Clinical Trials: | 199 |
Patent Applications: | 6,626 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends for MORPHINE SULFATE |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for MORPHINE SULFATE |
What excipients (inactive ingredients) are in MORPHINE SULFATE? | MORPHINE SULFATE excipients list |
DailyMed Link: | MORPHINE SULFATE at DailyMed |
Recent Clinical Trials for MORPHINE SULFATE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Canadian Institutes of Health Research (CIHR) | Phase 3 |
University of Calgary | Phase 3 |
Instituto Nacional de Cancer, Brazil | Phase 2 |
Pharmacology for MORPHINE SULFATE
Drug Class | Opioid Agonist |
Mechanism of Action | Full Opioid Agonists |
Medical Subject Heading (MeSH) Categories for MORPHINE SULFATE
Anatomical Therapeutic Chemical (ATC) Classes for MORPHINE SULFATE
Paragraph IV (Patent) Challenges for MORPHINE SULFATE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
MORPHABOND ER | Extended-release Tablets | morphine sulfate | 15 mg, 30 mg, 60 mg and 100 mg | 206544 | 1 | 2019-01-28 |
ARYMO ER | Extended-release Tablets | morphine sulfate | 15 mg, 30 mg and 60 mg | 208603 | 1 | 2017-12-29 |
AVINZA | Extended-release Capsules | morphine sulfate | 45 mg and 75 mg | 021260 | 1 | 2009-08-11 |
AVINZA | Extended-release Capsules | morphine sulfate | 30 mg, 60 mg, 90 mg and 120 mg | 021260 | 1 | 2007-06-04 |
US Patents and Regulatory Information for MORPHINE SULFATE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dr Reddys Labs Sa | MORPHINE SULFATE | morphine sulfate | TABLET;ORAL | 207270-001 | Jan 12, 2022 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Upsher Smith Labs | MORPHINE SULFATE | morphine sulfate | CAPSULE, EXTENDED RELEASE;ORAL | 202104-005 | Jun 3, 2013 | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Hikma | MORPHINE SULFATE | morphine sulfate | SOLUTION;ORAL | 022195-003 | Jan 25, 2010 | AA | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Novel Labs Inc | MORPHINE SULFATE | morphine sulfate | TABLET, EXTENDED RELEASE;ORAL | 203602-004 | Dec 16, 2015 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Tris Pharma Inc | MORPHINE SULFATE | morphine sulfate | SOLUTION;ORAL | 203519-001 | May 18, 2016 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Fresenius Kabi Usa | MORPHINE SULFATE | morphine sulfate | SOLUTION;INTRAMUSCULAR, INTRAVENOUS | 204223-003 | Oct 30, 2013 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Hikma | MORPHINE SULFATE | morphine sulfate | INJECTABLE;INJECTION | 211452-003 | Jan 12, 2023 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ 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 MORPHINE SULFATE
International Patents for MORPHINE SULFATE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Portugal | 2968729 | ⤷ Sign Up | |
European Patent Office | 2877161 | COMPOSITIONS PHARMACEUTIQUES DE DISSUASION D'ABUS À LIBÉRATION CONTRÔLÉE (ABUSE DETERRENT PHARMACEUTICAL COMPOSITIONS FOR CONTROLLED RELEASE) | ⤷ Sign Up |
New Zealand | 704011 | Abuse deterrent pharmaceutical compositions for controlled release | ⤷ Sign Up |
World Intellectual Property Organization (WIPO) | 2014006004 | ⤷ Sign Up | |
European Patent Office | 2331080 | COMPOSITIONS PHARMACEUTIQUES CONFIGURÉES POUR DISSUADER LE FRACTIONNEMENT DES FORMES POSOLOGIQUES (PHARMACEUTICAL COMPOSITIONS CONFIGURED TO DETER DOSAGE FORM SPLITTING) | ⤷ Sign Up |
Japan | 6215970 | ⤷ Sign Up | |
Japan | 5965583 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
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