MORPHINE SULFATE Drug Patent Profile
✉ Email this page to a colleague
When do Morphine Sulfate patents expire, and what generic alternatives are available?
Morphine Sulfate is a drug marketed by Actavis Elizabeth, Impax Labs Inc, Nortec Dev Assoc, Strides Pharma, Teva Pharms Usa, Upsher Smith Labs, Hikma, Hospira, Hospira Inc, Icu Medical Inc, Intl Medication Sys, Specgx Llc, Watson Labs, Fresenius Kabi Usa, Ani Pharms, Chartwell Molecular, Nostrum Labs Inc, Padagis Us, Pharm Assoc, Rhodes Pharms, Tris Pharma Inc, Vistapharm, Winder Labs Llc, Dava Pharms Inc, Dr Reddys Labs Sa, Epic Pharma Llc, Nesher Pharms, Novel Labs Inc, Rising, Sun Pharm Inds Ltd, Sun Pharm Industries, Alkem Labs Ltd, Ingenus Pharms Nj, and Meridian Medcl Techn. and is included in sixty-two NDAs. There are three patents protecting this drug.
This drug has twenty-four patent family members in eleven countries.
The generic ingredient in MORPHINE SULFATE is morphine sulfate. There are twenty-three drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the morphine sulfate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Morphine Sulfate
A generic version of MORPHINE SULFATE was approved as morphine sulfate by HOSPIRA on May 11th, 1988.
Summary for MORPHINE SULFATE
International Patents: | 24 |
US Patents: | 3 |
Applicants: | 34 |
NDAs: | 62 |
Finished Product Suppliers / Packagers: | 28 |
Raw Ingredient (Bulk) Api Vendors: | 24 |
Clinical Trials: | 198 |
Patent Applications: | 4,426 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information 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 |
---|---|
Instituto Nacional de Cancer, Brazil | Phase 2 |
Beni-Suef University | Phase 2 |
Cairo University | Phase 4 |
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
MORPHINE SULFATE is protected by four US patents and one FDA Regulatory Exclusivity.
Patents protecting MORPHINE SULFATE
Morphine formulations
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Morphine formulations
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: MANAGEMENT OF CHRONIC PAIN IN PATIENTS REQUIRING OPIOID ANALGESIA
Morphine formulations
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF PAIN
Packaging system for oxygen-sensitive drugs
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
FDA Regulatory Exclusivity protecting MORPHINE SULFATE
NEW PATIENT POPULATION
Exclusivity Expiration: ⤷ Try a Trial
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Fresenius Kabi Usa | MORPHINE SULFATE | morphine sulfate | SOLUTION;INTRAMUSCULAR, INTRAVENOUS | 204223-001 | Oct 30, 2013 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Nostrum Labs Inc | MORPHINE SULFATE | morphine sulfate | SOLUTION;ORAL | 201011-003 | Oct 6, 2016 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Hikma | MORPHINE SULFATE | morphine sulfate | INJECTABLE;INJECTION | 211452-001 | Jan 12, 2023 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Teva Pharms Usa | MORPHINE SULFATE | morphine sulfate | CAPSULE, EXTENDED RELEASE;ORAL | 202718-005 | Dec 29, 2014 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Sun Pharm Industries | MORPHINE SULFATE | morphine sulfate | TABLET, EXTENDED RELEASE;ORAL | 205634-002 | Aug 25, 2016 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Strides Pharma | MORPHINE SULFATE | morphine sulfate | TABLET, EXTENDED RELEASE;ORAL | 075295-002 | Oct 28, 1998 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a 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 MORPHINE SULFATE
See the table below for patents covering MORPHINE SULFATE around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
China | 104528165 | Packaging system for oxygen-sensitive drugs | ⤷ Try a Trial |
Australia | 2014230836 | Packaging system for oxygen-sensitive drugs | ⤷ Try a Trial |
Japan | 6215970 | ⤷ Try a Trial | |
Canada | 2902346 | SYSTEME DE CONDITIONNEMENT POUR MEDICAMENTS SENSIBLES A L'OXYGENE (PACKAGING SYSTEM FOR OXYGEN-SENSITIVE DRUGS) | ⤷ Try a Trial |
China | 204798475 | ⤷ Try a Trial | |
Canada | 2902343 | FORMULATIONS INJECTABLES DE MORPHINE (INJECTABLE MORPHINE FORMULATIONS) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |