FYARRO Drug Patent Profile
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Which patents cover Fyarro, and what generic alternatives are available?
Fyarro is a drug marketed by Aadi and is included in one NDA. There are six patents protecting this drug.
This drug has one hundred and fifty patent family members in thirty-two countries.
The generic ingredient in FYARRO is sirolimus. There are twenty-one drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the sirolimus profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Fyarro
A generic version of FYARRO was approved as sirolimus by ZYDUS PHARMS on January 8th, 2014.
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Questions you can ask:
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Summary for FYARRO
International Patents: | 150 |
US Patents: | 6 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 68 |
Clinical Trials: | 1 |
Patent Applications: | 2,713 |
Drug Prices: | Drug price information for FYARRO |
What excipients (inactive ingredients) are in FYARRO? | FYARRO excipients list |
DailyMed Link: | FYARRO at DailyMed |
Recent Clinical Trials for FYARRO
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Mirati Therapeutics Inc. | Phase 1/Phase 2 |
Aadi Bioscience, Inc. | Phase 1/Phase 2 |
Pharmacology for FYARRO
Drug Class | Kinase Inhibitor mTOR Inhibitor Immunosuppressant |
Mechanism of Action | Protein Kinase Inhibitors mTOR Inhibitors |
Physiological Effect | Decreased Immunologic Activity |
US Patents and Regulatory Information for FYARRO
FYARRO is protected by six US patents and two FDA Regulatory Exclusivities.
Patents protecting FYARRO
Prion free nanoparticle compositions and methods of making thereof
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Methods of assessing suitability of use of pharmaceutical compositions of albumin and poorly water soluble drug
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Methods of treating epithelioid cell tumors comprising administering a composition comprising nanoparticles comprising an mTOR inhibitor and an albumin
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Patented Use: TREATMENT OF ADULT PATIENTS WITH LOCALLY ADVANCED UNRESECTABLE OR METASTATIC MALIGNANT PERIVASCULAR EPITHELIOID CELL TUMOR (PECOMA) WITH A DOSE BETWEEN ABOUT 56 MG/M2 AND ABOUT 100 MG/M2 ADMINISTERED ON DAYS 1 AND 8 OF A 21-DAY CYCLE
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Nanoparticle comprising rapamycin and albumin as anticancer agent
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Patented Use: TREATMENT OF ADULT PATIENTS WITH LOCALLY ADVANCED UNRESECTABLE OR METASTATIC MALIGNANT PERIVASCULAR EPITHELIOID CELL TUMOR (PECOMA)
FDA Regulatory Exclusivity protecting FYARRO
NEW PRODUCT
Exclusivity Expiration: ⤷ Sign Up
FOR THE TREATMENT OF ADULT PATIENTS WITH LOCALLY ADVANCED UNRESECTABLE OR METASTATIC MALIGNANT PERIVASCULAR EPITHELIOID CELL TUMOR (PECOMA)
Exclusivity Expiration: ⤷ Sign Up
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Aadi | FYARRO | sirolimus | POWDER;INTRAVENOUS | 213312-001 | Nov 22, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Aadi | FYARRO | sirolimus | POWDER;INTRAVENOUS | 213312-001 | Nov 22, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Aadi | FYARRO | sirolimus | POWDER;INTRAVENOUS | 213312-001 | Nov 22, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
EU/EMA Drug Approvals for FYARRO
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Pfizer Europe MA EEIG | Rapamune | sirolimus | EMEA/H/C/000273 Rapamune is indicated for the prophylaxis of organ rejection in adult patients at low to moderate immunological risk receiving a renal transplant. It is recommended that Rapamune be used initially in combination with ciclosporin microemulsion and corticosteroids for 2 to 3 months. Rapamune may be continued as maintenance therapy with corticosteroids only if ciclosporin microemulsion can be progressively discontinued., , Rapamune is indicated for the treatment of patients with sporadic lymphangioleiomyomatosis with moderate lung disease or declining lung function., |
Authorised | no | no | no | 2001-03-13 | |
Plusultra pharma GmbH | Hyftor | sirolimus | EMEA/H/C/005896 Hyftor is indicated for the treatment of facial angiofibroma associated with tuberous sclerosis complex in adults and paediatric patients aged 6 years and older. |
Authorised | no | no | yes | 2023-05-15 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for FYARRO
See the table below for patents covering FYARRO around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
World Intellectual Property Organization (WIPO) | 2008109163 | ⤷ Sign Up | |
European Patent Office | 3417859 | NANOPARTICULE COMPRENANT DE LA RAPAMYCINE ET DE L'ALBUMINE EN TANT QU'AGENT ANTI-CANCÉREUX (NANOPARTICLE COMPRISING RAPAMYCIN AND ALBUMIN AS ANTICANCER AGENT) | ⤷ Sign Up |
Portugal | 3313401 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for FYARRO
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0763039 | 18/2008 | Austria | ⤷ Sign Up | PRODUCT NAME: TEMSIROLIMUS ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/07/424/001 20071119 |
0648494 | C300055 | Netherlands | ⤷ Sign Up | PRODUCT NAME: SIROLIMUS, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AAN- VAARDBAAR ZOUT; NATL. REGISTRATION NO/DATE: EU/1/01/171/001 - EU/1/01/171/005 20010313; FIRST REGISTRATION: CH CH/55243 20000926 |
0401747 | 25/2001 | Austria | ⤷ Sign Up | PRODUCT NAME: SIROLIMUS; NAT. REGISTRATION NO/DATE: EU/1/01/171/001 - EU/1/01/171/005 20010313; FIRST REGISTRATION: LI 5524301 20000926 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |