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. Nineteen 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: | 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 |
|---|---|
| Aadi Bioscience, Inc. | Phase 1/Phase 2 |
| Mirati Therapeutics 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 | |||
| 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 | |||
| >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 |
|---|---|---|---|
| Croatia | P20192259 | ⤷ Sign Up | |
| China | 116585310 | 治疗上皮样细胞肿瘤的方法 (Methods of treating epithelial cell tumors) | ⤷ Sign Up |
| Spain | 2897991 | ⤷ Sign Up | |
| South Africa | 201708567 | METHODS OF TREATING EPITHELIOID CELL TUMORS | ⤷ Sign Up |
| Japan | 2018150381 | 抗癌剤としてラパマイシンおよびアルブミンを含むナノ粒子 (NANOPARTICLE COMPRISING RAPAMYCIN AND ALBUMIN AS ANTICANCER AGENT) | ⤷ Sign Up |
| Portugal | 2131821 | ⤷ 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 | C00648494/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: SIROLIMUS; REGISTRATION NO/DATE: IKS 55243 20000926 |
| 0763039 | PA2008009,C0763039 | Lithuania | ⤷ Sign Up | PRODUCT NAME: TEMSIROLIMUSUM; REGISTRATION NO/DATE: EU/1/07/424/001 20071119 |
| 0763039 | C300348 | Netherlands | ⤷ Sign Up | PRODUCT NAME: TEMSIROLIMUS, DESGEWENST IN DE VORM VAN EEN; REGISTRATION NO/DATE: EU/1/07/424/001 20071119 |
| 0763039 | 08C0018 | France | ⤷ Sign Up | PRODUCT NAME: TEMSIROLIMUS; REGISTRATION NO/DATE: EU/1/07/424/001 20071119 |
| 0648494 | 24/2001 | 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 |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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