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MOVANTIK Drug Profile
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When do Movantik patents expire, and when can generic versions of Movantik launch?
Movantik is a drug marketed by Astrazeneca Pharms and is included in one NDA. There are six patents protecting this drug and one Paragraph IV challenge.
This drug has one hundred and ten patent family members in forty countries.
The generic ingredient in MOVANTIK is naloxegol oxalate. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the naloxegol oxalate profile page.
US ANDA Litigation and Generic Entry Outlook for Movantik
Movantik was eligible for patent challenges on September 16, 2018.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be April 2, 2032. This may change due to patent challenges or generic licensing.
There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.
Indicators of Generic Entry
Summary for MOVANTIK
| International Patents: | 110 |
| US Patents: | 6 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 11 |
| Clinical Trials: | 13 |
| Patent Applications: | 2 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for MOVANTIK |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for MOVANTIK |
| DailyMed Link: | MOVANTIK at DailyMed |
Generic Entry Opportunity Date for MOVANTIK
Generic Entry Date for MOVANTIK*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for MOVANTIK
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Camille Ladanyi MD | N/A |
| University of Missouri-Columbia | Phase 4 |
| Angela Fellner | Phase 2/Phase 3 |
Recent Litigation for MOVANTIK
Identify potential future generic entrants
PTAB Litigation
| Petitioner | Date |
|---|---|
| Neptune Generics, LLC | 2015-10-15 |
Pharmacology for MOVANTIK
| Drug Class | Opioid Antagonist |
| Mechanism of Action | Opioid Antagonists |
Synonyms for MOVANTIK
| (4R,4aS,7S,7aR,12bS)-7-[2-[2-[2-[2-[2-[2-(2-methoxyethoxy)ethoxy]ethoxy]ethoxy]ethoxy]ethoxy]ethoxy]-3-prop-2-enyl-1,2,4,5,6,7,7a,13-octahydro-4,12-methanobenzofuro[3,2-e]isoquinoline-4a,9-diol |
| (5alpha,6alpha)-17-Allyl-6-[(20-hydroxy-3,6,9,12,15,18-hexaoxaicos-1-yl)oxy]-4,5-epoxymorphinan-3,14-diol |
| 44T7335BKE |
| 854601-70-0 |
| AKOS030526932 |
| AZ-13337019 |
| AZ13337019 |
| CHEBI:82975 |
| CHEMBL2219418 |
| CS-4987 |
| D10479 |
| DB09049 |
| DTXSID80234684 |
| GTPL7539 |
| HSDB 8338 |
| HY-A0118 |
| Morphinan-3,14-diol, 4,5-epoxy-6-(3,6,9,12,15,18,21-heptaoxadocos-1-yloxy)- 17-(2-propenyl)-, (5alpha,6alpha)- |
| moventig |
| Naloxegol |
| Naloxegol (USAN/INN) |
| Naloxegol [USAN:INN] |
| NKTR 118 |
| NKTR-118 |
| NKTR118 |
| SCHEMBL19433066 |
| UNII-44T7335BKE |
| ZINC95564694 |
Paragraph IV (Patent) Challenges for MOVANTIK
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| MOVANTIK | TABLET;ORAL | naloxegol oxalate | 204760 | 2018-09-17 |
US Patents and Regulatory Information for MOVANTIK
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Astrazeneca Pharms | MOVANTIK | naloxegol oxalate | TABLET;ORAL | 204760-001 | Sep 16, 2014 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Astrazeneca Pharms | MOVANTIK | naloxegol oxalate | TABLET;ORAL | 204760-001 | Sep 16, 2014 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Astrazeneca Pharms | MOVANTIK | naloxegol oxalate | TABLET;ORAL | 204760-001 | Sep 16, 2014 | RX | Yes | No | Start Trial | Start Trial | Y | 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 MOVANTIK
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Denmark | 2621496 | Start Trial |
| China | 103237547 | Start Trial |
| Mexico | 2013003587 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for MOVANTIK
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1694363 | PA2015019 | Lithuania | Start Trial | PRODUCT NAME: NALOXEGOLUM; REGISTRATION NO/DATE: EU/1/14/962 20141208 |
| 1694363 | C300737 | Netherlands | Start Trial | PRODUCT NAME: NALOXEGOL ALSMEDE DOOR HET BASISOCTROOI; REGISTRATION NO/DATE: EU/1/14/962 20141208 |
| 1694363 | 27/2015 | Austria | Start Trial | PRODUCT NAME: NALOXEGOL, GEGEBENENFALLS IN FORM EINES THERAPEUTISCH VERTRAEGLICHEN SALZES, INSBESONDERE ALS OXALAT; REGISTRATION NO/DATE: EU/1/14/962 20141208 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
