DrugPatentWatch Database Preview
MOVANTIK Drug Profile
» See Plans and Pricing
Which patents cover Movantik, and when can generic versions of Movantik launch?
Movantik is a drug marketed by Redhill and is included in one NDA. There are six patents protecting this drug and one Paragraph IV challenge.
This drug has one hundred and twelve patent family members in forty-one countries.
The generic ingredient in MOVANTIK is naloxegol oxalate. There are three drug master file entries for this compound. Three suppliers are 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: | 112 |
| US Patents: | 6 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 3 |
| Bulk Api Vendors: | 11 |
| Clinical Trials: | 13 |
| Patent Applications: | 62 |
| 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 |
Pharmacology for MOVANTIK
| Drug Class | Opioid Antagonist |
| Mechanism of Action | Opioid Antagonists |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Redhill | MOVANTIK | naloxegol oxalate | TABLET;ORAL | 204760-001 | Sep 16, 2014 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Redhill | MOVANTIK | naloxegol oxalate | TABLET;ORAL | 204760-002 | Sep 16, 2014 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Redhill | MOVANTIK | naloxegol oxalate | TABLET;ORAL | 204760-001 | Sep 16, 2014 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Redhill | MOVANTIK | naloxegol oxalate | TABLET;ORAL | 204760-002 | Sep 16, 2014 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Redhill | MOVANTIK | naloxegol oxalate | TABLET;ORAL | 204760-002 | Sep 16, 2014 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Redhill | MOVANTIK | naloxegol oxalate | TABLET;ORAL | 204760-001 | Sep 16, 2014 | RX | Yes | No | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Redhill | 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 |
|---|---|---|
| Nicaragua | 201300034 | Start Trial |
| Australia | 2012227249 | Start Trial |
| Hungary | E026726 | Start Trial |
| Eurasian Patent Organization | 015333 | Start Trial |
| San Marino | T201600004 | Start Trial |
| Japan | 6034789 | Start Trial |
| South Korea | 20060126714 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for MOVANTIK
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1694363 | 1590027-7 | Sweden | Start Trial | PRODUCT NAME: NALOXEGOL; REG. NO/DATE: EU/1/14/962 20141210 |
| 1694363 | 234 5008-2015 | Slovakia | Start Trial | PRODUCT NAME: OXALAT NALOXEGOLU; REGISTRATION NO/DATE: EU/1/14/962 20141210 |
| 1694363 | 122015000037 | Germany | Start Trial | PRODUCT NAME: NALOXEGOL ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/14/962 20141208 |
| 1694363 | 300737 | Netherlands | Start Trial | PRODUCT NAME: NALOXEGOL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER NALOGEXOLOXALAAT; REGISTRATION NO/DATE: EU/1/14/962 20141210 |
| 1694363 | 592 | Finland | Start Trial | |
| 1694363 | C01694363/01 | Switzerland | Start Trial | PRODUCT NAME: NALOXEGOLUM; REGISTRATION NO/DATE: SWISSMEDIC 65205 08.07.2015 |
| 1694363 | PA2015019,C1694363 | Lithuania | Start Trial | PRODUCT NAME: NALOKSEGOLAS, KONKRECIAI NALOKSEGOLO OKSALATO DRUSKA; REGISTRATION NO/DATE: EU/1/14/962 20141208 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
