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XERMELO Drug Profile
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» See Plans and PricingWhich patents cover Xermelo, and when can generic versions of Xermelo launch?
Xermelo is a drug marketed by Lexicon Pharms Inc and is included in one NDA. There are five patents protecting this drug.
This drug has sixty-two patent family members in twenty-nine countries.
The generic ingredient in XERMELO is telotristat etiprate. One supplier is listed for this compound. Additional details are available on the telotristat etiprate profile page.
US ANDA Litigation and Generic Entry Outlook for Xermelo
Xermelo will be eligible for patent challenges on February 28, 2021. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be February 27, 2031. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for XERMELO
| International Patents: | 62 |
| US Patents: | 5 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 35 |
| Clinical Trials: | 3 |
| Patent Applications: | 28 |
| Drug Prices: | Drug price information for XERMELO |
| DailyMed Link: | XERMELO at DailyMed |
Generic Entry Opportunity Date for XERMELO
Generic Entry Date for XERMELO*:
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 XERMELO
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| European Organisation for Research and Treatment of Cancer - EORTC | Phase 3 |
| Emory University | Phase 2 |
| Ipsen | Phase 3 |
Pharmacology for XERMELO
| Drug Class | Tryptophan Hydroxylase Inhibitor |
| Mechanism of Action | Tryptophan Hydroxylase Inhibitors |
US Patents and Regulatory Information for XERMELO
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Lexicon Pharms Inc | XERMELO | telotristat etiprate | TABLET;ORAL | 208794-001 | Feb 28, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Lexicon Pharms Inc | XERMELO | telotristat etiprate | TABLET;ORAL | 208794-001 | Feb 28, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Lexicon Pharms Inc | XERMELO | telotristat etiprate | TABLET;ORAL | 208794-001 | Feb 28, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Lexicon Pharms Inc | XERMELO | telotristat etiprate | TABLET;ORAL | 208794-001 | Feb 28, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Lexicon Pharms Inc | XERMELO | telotristat etiprate | TABLET;ORAL | 208794-001 | Feb 28, 2017 | RX | Yes | Yes | Start Trial | Start Trial | 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 XERMELO
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Eurasian Patent Organization | 201070410 | Start Trial |
| Brazil | PI0720270 | Start Trial |
| Colombia | 6220855 | Start Trial |
| Colombia | 6270325 | Start Trial |
| New Zealand | 577004 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for XERMELO
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2091940 | 2018C/009 | Belgium | Start Trial | PRODUCT NAME: TELOTRISTAT, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ESTER OF ZOUT, IN HET BIJZONDER TELOTRISTAT ETHYL, MEER IN HET BIJZONDER HET HIPPURAAT ZOUT VAN TELOTRISTAT ETHYL; AUTHORISATION NUMBER AND DATE: EU/1/17/1224 20170920 |
| 2091940 | 11/2018 | Austria | Start Trial | PRODUCT NAME: TELOTRISTAT ODER EIN PHARMAZEUTISCH ANNEHMBARER ESTER, ODER EIN SALZ DAVON, INSBESONDERE TELOTRISTATETHYL, INSBESONDERE DAS HIPPURATSALZ VON TELOTRISTATETHYL; REGISTRATION NO/DATE: EU/1/17/1224 (MITTEILUNG) 20170920 |
| 2091940 | 2018/011 | Ireland | Start Trial | PRODUCT NAME: TELOTRISTAT OR A PHARMACEUTICALLY ACCEPTABLE ESTER, OR A SALT THEROF, IN PARTICULAR TELOTRISTAT ETHYL, MORE PARTICULARLY HIPPURATE SALT OF TELOTRISTAT ETHYL.; REGISTRATION NO/DATE: EU/1/17/1224 20170918 |
| 2091940 | 132018000000181 | Italy | Start Trial | PRODUCT NAME: TELOTRISTAT O UN SUO ESTERE FARMACEUTICAMENTE ACCETTABILE, O UN SUO SALE, IN PARTICOLARE TELOTRISTAT ETILE, PIU IN PARTICOLARE SALE IPPURATO DI TELOTRISAT ETILE(XERMELO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1224, 20170920 |
| 2091940 | 1890014-2 | Sweden | Start Trial | PRODUCT NAME: TELOTRISTAT OR A PHARMACEUTICALLY ACCEPTABLE ESTER, OR A SALT THEREOF, IN PARTICULARLY TELOTRISTAT ETHYL, MORE PARTICULARLY HIPPURATE SALT OF TELOTRISTAT ETHYL; REG. NO/DATE: EU/1/17/1224 20170920 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
