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Last Updated: September 25, 2022

ASTAGRAF XL Drug Patent Profile


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When do Astagraf Xl patents expire, and when can generic versions of Astagraf Xl launch?

Astagraf Xl is a drug marketed by Astellas and is included in one NDA.

The generic ingredient in ASTAGRAF XL is tacrolimus. There are twenty drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the tacrolimus profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Astagraf Xl

A generic version of ASTAGRAF XL was approved as tacrolimus by SANDOZ on August 10th, 2009.

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Drug patent expirations by year for ASTAGRAF XL
Drug Prices for ASTAGRAF XL

See drug prices for ASTAGRAF XL

Recent Clinical Trials for ASTAGRAF XL

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of Colorado, DenverEarly Phase 1
Cedars-Sinai Medical CenterPhase 4
Medical University of South CarolinaPhase 4

See all ASTAGRAF XL clinical trials

Pharmacology for ASTAGRAF XL
Paragraph IV (Patent) Challenges for ASTAGRAF XL
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ASTAGRAF XL Extended-release Capsules tacrolimus 0.5 mg, 1 mg, and 5 mg 204096 1 2013-09-24

US Patents and Regulatory Information for ASTAGRAF XL

ASTAGRAF XL is protected by zero US patents and one FDA Regulatory Exclusivity.

FDA Regulatory Exclusivity protecting ASTAGRAF XL

FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S).AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S)
Exclusivity Expiration: See Plans and Pricing

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astellas ASTAGRAF XL tacrolimus CAPSULE, EXTENDED RELEASE;ORAL 204096-001 Jul 19, 2013 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Astellas ASTAGRAF XL tacrolimus CAPSULE, EXTENDED RELEASE;ORAL 204096-002 Jul 19, 2013 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Astellas ASTAGRAF XL tacrolimus CAPSULE, EXTENDED RELEASE;ORAL 204096-003 Jul 19, 2013 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for ASTAGRAF XL

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astellas ASTAGRAF XL tacrolimus CAPSULE, EXTENDED RELEASE;ORAL 204096-003 Jul 19, 2013 See Plans and Pricing See Plans and Pricing
Astellas ASTAGRAF XL tacrolimus CAPSULE, EXTENDED RELEASE;ORAL 204096-003 Jul 19, 2013 See Plans and Pricing See Plans and Pricing
Astellas ASTAGRAF XL tacrolimus CAPSULE, EXTENDED RELEASE;ORAL 204096-001 Jul 19, 2013 See Plans and Pricing See Plans and Pricing
Astellas ASTAGRAF XL tacrolimus CAPSULE, EXTENDED RELEASE;ORAL 204096-002 Jul 19, 2013 See Plans and Pricing See Plans and Pricing
Astellas ASTAGRAF XL tacrolimus CAPSULE, EXTENDED RELEASE;ORAL 204096-001 Jul 19, 2013 See Plans and Pricing See Plans and Pricing
Astellas ASTAGRAF XL tacrolimus CAPSULE, EXTENDED RELEASE;ORAL 204096-001 Jul 19, 2013 See Plans and Pricing See Plans and Pricing
Astellas ASTAGRAF XL tacrolimus CAPSULE, EXTENDED RELEASE;ORAL 204096-003 Jul 19, 2013 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for ASTAGRAF XL

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Astellas Pharma Europe B.V. Modigraf tacrolimus EMEA/H/C/000954
Prophylaxis of transplant rejection in adult and paediatric, kidney, liver or heart allograft recipients.Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult and paediatric patients.
Authorised no no no 2009-05-15
Astellas Pharma Europe B.V. Advagraf tacrolimus EMEA/H/C/000712
Prophylaxis of transplant rejection in adult kidney or liver allograft recipients.Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult patients.
Authorised no no no 2007-04-23
Chiesi Farmaceutici S.p.A. Envarsus tacrolimus EMEA/H/C/002655
Prophylaxis of transplant rejection in adult kidney or liver allograft recipients. Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult patients.
Authorised no no no 2014-07-18
LEO Pharma A/S Protopic tacrolimus EMEA/H/C/000374
Flare treatmentAdults and adolescents (16 years of age and above)Treatment of moderate to severe atopic dermatitis in adults who are not adequately responsive to or are intolerant of conventional therapies such as topical corticosteroids.Children (two years of age and above)Treatment of moderate to severe atopic dermatitis in children (two years of age and above) who failed to respond adequately to conventional therapies such as topical corticosteroids.Maintenance treatmentMaintenance treatment of moderate to severe atopic dermatitis for the prevention of flares and the prolongation of flare-free intervals in patients experiencing a high frequency of disease exacerbations (i.e. occurring four or more times per year) who have had an initial response to a maximum of six weeks treatment of twice daily tacrolimus ointment (lesions cleared, almost cleared or mildly affected).
Authorised no no no 2002-02-27
Teva B.V. Tacforius tacrolimus EMEA/H/C/004435
Prophylaxis of transplant rejection in adult kidney or liver allograft recipients., , Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult patients.,
Authorised yes no no 2017-12-08
Astellas Pharma GmbH Protopy tacrolimus EMEA/H/C/000375
Treatment of moderate to severe atopic dermatitis in adults who are not adequately responsive to or are intolerant of conventional therapies such as topical corticosteroids. Treatment of moderate to severe atopic dermatitis in children (2 years of age and above) who failed to respond adequately to conventional therapies such as topical corticosteroids.Maintenance treatment of moderate to severe atopic dermatitis for the prevention of flares and the prolongation of flare-free intervals in patients experiencing a high frequency of disease exacerbations (i.e. occurring 4 or more times per year) who have had an initial response to a maximum of 6 weeks treatment of twice daily tacrolimus ointment (lesions cleared, almost cleared or mildly affected).
Withdrawn no no no 2002-02-28
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for ASTAGRAF XL

See the table below for patents covering ASTAGRAF XL around the world.

Country Patent Number Title Estimated Expiration
Portugal 1421939 See Plans and Pricing
Taiwan I235068 See Plans and Pricing
European Patent Office 1421939 Composition pharmaceutique à liberation prolongée contenant un macrolide comme tacrolimus (Sustained release preparation of a macrolide compound like tacrolimus) See Plans and Pricing
Norway 330578 See Plans and Pricing
Norway 20004773 See Plans and Pricing
Indonesia 27825 See Plans and Pricing
Austria 514419 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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