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VELTASSA Drug Profile
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» See Plans and PricingWhich patents cover Veltassa, and when can generic versions of Veltassa launch?
Veltassa is a drug marketed by Relypsa Inc and is included in one NDA. There are twelve patents protecting this drug.
This drug has one hundred and seventy-one patent family members in twenty-five countries.
The generic ingredient in VELTASSA is patiromer sorbitex calcium. One supplier is listed for this compound. Additional details are available on the patiromer sorbitex calcium profile page.
US ANDA Litigation and Generic Entry Outlook for Veltassa
Veltassa was eligible for patent challenges on October 21, 2019.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be May 29, 2030. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for VELTASSA
| International Patents: | 171 |
| US Patents: | 12 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 1 |
| Clinical Trials: | 12 |
| Drug Prices: | Drug price information for VELTASSA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for VELTASSA |
| DailyMed Link: | VELTASSA at DailyMed |
Generic Entry Opportunity Date for VELTASSA
Generic Entry Date for VELTASSA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
POWDER;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 VELTASSA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| NHS Greater Glasgow and Clyde | Phase 4 |
| University of Glasgow | Phase 4 |
| Vifor Pharma | Phase 3 |
Pharmacology for VELTASSA
| Drug Class | Potassium Binder |
| Mechanism of Action | Potassium Ion Binding Activity |
Synonyms for VELTASSA
| 0LB9J2797D |
| 1415477-49-4 |
| Calcium, hydrolyzed divinylbenzene-Me 2-fluoro-2-propenoate-1,7-octadiene polymer sorbitol complexes |
| Cross-linked polymer of calcium 2-fluoroprop-2-enoate with diethenylbenzene and octa-1,7-diene, combination with D-glucitol |
| Patiromer sorbitex calcium |
| Patiromer sorbitex calcium [USAN] |
| RLY5016S |
| UNII-0LB9J2797D |
Paragraph IV (Patent) Challenges for VELTASSA
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| VELTASSA | POWDER;ORAL | patiromer sorbitex calcium | 205739 | 2019-10-21 |
US Patents and Regulatory Information for VELTASSA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Relypsa Inc | VELTASSA | patiromer sorbitex calcium | POWDER;ORAL | 205739-003 | Oct 21, 2015 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Relypsa Inc | VELTASSA | patiromer sorbitex calcium | POWDER;ORAL | 205739-003 | Oct 21, 2015 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Relypsa Inc | VELTASSA | patiromer sorbitex calcium | POWDER;ORAL | 205739-003 | Oct 21, 2015 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Relypsa Inc | VELTASSA | patiromer sorbitex calcium | POWDER;ORAL | 205739-003 | Oct 21, 2015 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Relypsa Inc | VELTASSA | patiromer sorbitex calcium | POWDER;ORAL | 205739-001 | Oct 21, 2015 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Relypsa Inc | VELTASSA | patiromer sorbitex calcium | POWDER;ORAL | 205739-002 | Oct 21, 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 VELTASSA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Brazil | PI0509331 | Start Trial |
| Germany | 112005000708 | Start Trial |
| Japan | 2016145256 | Start Trial |
| South Korea | 101362509 | Start Trial |
| Japan | 2007531726 | Start Trial |
| United Kingdom | 2495427 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for VELTASSA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2957286 | 2018/046 | Ireland | Start Trial | PRODUCT NAME: PATIROMER SORBITEX CALCIUM; REGISTRATION NO/DATE: EU/1/17/1179 20170719 |
| 1732523 | 132018000000061 | Italy | Start Trial | PRODUCT NAME: PATIROMER E QUALSIASI SUO SALE O DERIVATO(VELTASSA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1179, 20170721 |
| 2957286 | 1990003-4 | Sweden | Start Trial | PRODUCT NAME: PATRIOMER SORBITEX CALCIUM; REG. NO/DATE: EU/1/17/1179 20170721 |
| 1732523 | 2018C/004 | Belgium | Start Trial | PRODUCT NAME: PATIROMER OF EENDER WELK ZOUT OF AFGELEIDE ERVAN; AUTHORISATION NUMBER AND DATE: EU/1/17/1179 20170721 |
| 2957286 | PA2018016,C2957286 | Lithuania | Start Trial | PRODUCT NAME: PATIROMERO, SORBITOLIO IR KALCIO KOMPLEKSAS; REGISTRATION NO/DATE: EU/1/17/1179 20170719 |
| 2957286 | PA2018016 | Lithuania | Start Trial | PRODUCT NAME: PATIROMERO, SORBITOLIO IR KALCIO KOMPLEKSAS; REGISTRATION NO/DATE: EU/1/17/1179 20170719 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
