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 five 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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Summary for FYARRO
International Patents: | 150 |
US Patents: | 5 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 68 |
Clinical Trials: | 1 |
Patent Applications: | 2,713 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for FYARRO |
What excipients (inactive ingredients) are in FYARRO? | FYARRO excipients list |
DailyMed Link: | FYARRO at DailyMed |
![FYARRO drug patent expirations Drug patent expirations by year for FYARRO](/p/graph/s/t/FYARRO-patent-expirations.png)
![Drug Prices for FYARRO](/p/graph/drug-price/FYARRO.png)
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 five US patents and two FDA Regulatory Exclusivities.
Patents protecting FYARRO
Prion free nanoparticle compositions and methods of making thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Methods of assessing suitability of use of pharmaceutical compositions of albumin and poorly water soluble drug
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Methods of treating epithelioid cell tumors comprising administering a composition comprising nanoparticles comprising an mTOR inhibitor and an albumin
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Nanoparticle comprising rapamycin and albumin as anticancer agent
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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 | |||
Aadi | FYARRO | sirolimus | POWDER;INTRAVENOUS | 213312-001 | Nov 22, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Aadi | FYARRO | sirolimus | POWDER;INTRAVENOUS | 213312-001 | Nov 22, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Aadi | FYARRO | sirolimus | POWDER;INTRAVENOUS | 213312-001 | Nov 22, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ 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 |
---|---|---|---|
Denmark | 2481409 | ⤷ Sign Up | |
Hungary | E038701 | ⤷ Sign Up | |
South Korea | 101943230 | ⤷ Sign Up | |
Denmark | 2131821 | ⤷ Sign Up | |
New Zealand | 738936 | Methods of treating epithelioid cell tumors | ⤷ Sign Up |
Slovenia | 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 | C300348 | Netherlands | ⤷ Sign Up | PRODUCT NAME: TEMSIROLIMUS, DESGEWENST IN DE VORM VAN EEN; REGISTRATION NO/DATE: EU/1/07/424/001 20071119 |
0763039 | PA2008009,C0763039 | Lithuania | ⤷ Sign Up | PRODUCT NAME: TEMSIROLIMUSUM; REGISTRATION NO/DATE: EU/1/07/424/001 20071119 |
0401747 | SPC/GB01/036 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: SIROLIMUS; REGISTERED: CH IKS 55243 20000926; UK EU/1/01/171/001-005 20010313 |
0763039 | 08C0018 | France | ⤷ Sign Up | PRODUCT NAME: TEMSIROLIMUS; REGISTRATION NO/DATE: EU/1/07/424/001 20071119 |
0648494 | SPC/GB01/037 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: SIROLIMUS; REGISTERED: CH IKS 55243 20000926; UK EU/1/01/171/001-005 20010313 |
0763039 | 122008000023 | Germany | ⤷ Sign Up | PRODUCT NAME: TEMSIROLIMUS ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/07/424/001 20071119 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |