PROGRAF Drug Patent Profile

Which patents cover Prograf, and what generic alternatives are available?

Prograf is a drug marketed by Astellas and is included in three NDAs.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Prograf

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

Summary for PROGRAF

US Patents:	0
Applicants:	1
NDAs:	3
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	405
Drug Prices:	Drug price information for PROGRAF
What excipients (inactive ingredients) are in PROGRAF?	PROGRAF excipients list
DailyMed Link:	PROGRAF at DailyMed

See drug prices for PROGRAF

See drug sales revenues for PROGRAF

Recent Clinical Trials for PROGRAF

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

Sponsor	Phase
Veloxis Pharmaceuticals	PHASE4
Massachusetts General Hospital	PHASE4
University Hospital, Limoges	PHASE4

See all PROGRAF clinical trials

Pharmacology for PROGRAF

Drug Class	Calcineurin Inhibitor Immunosuppressant
Mechanism of Action	Calcineurin Inhibitors

US Patents and Regulatory Information for PROGRAF

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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astellas	PROGRAF	tacrolimus	CAPSULE;ORAL	050708-003	Aug 24, 1998	AB	RX	Yes	No
Astellas	PROGRAF	tacrolimus	FOR SUSPENSION;ORAL	210115-001	May 24, 2018		RX	Yes	No
Astellas	PROGRAF	tacrolimus	CAPSULE;ORAL	050708-001	Apr 8, 1994	AB	RX	Yes	No

Expired US Patents for PROGRAF

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astellas	PROGRAF	tacrolimus	INJECTABLE;INJECTION	050709-001	Apr 8, 1994	5,260,301

EU/EMA Drug Approvals for PROGRAF

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Astellas Pharma Europe B.V.	Modigraf	tacrolimus	EMEA/H/C/000954Prophylaxis 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 BV	Advagraf	tacrolimus	EMEA/H/C/000712Prophylaxis 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/002655Prophylaxis 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

International Patents for PROGRAF

See the table below for patents covering PROGRAF around the world.

Country	Patent Number	Title	Estimated Expiration
Austria	143598
Australia	642707
Australia	7194991

PROGRAF (tacrolimus): Market Dynamics and Financial Trajectory, Patent/Generic Risk, and Competitive Landscape

Last updated: July 29, 2026

PROGRAF (tacrolimus) is a cornerstone maintenance therapy for solid-organ transplant immunosuppression in the US and major ex-US markets. The commercial trajectory is dominated by (1) erosion from tacrolimus generic entry in multiple geographies, (2) competitive pressure from branded and generic tacrolimus formulations and distribution contracts, and (3) lifecycle strategy around extended-release and alternative tacrolimus products. As a result, PROGRAF’s peak revenue era has already passed in most mature markets, with value preserved largely by formulary placement, inventory stocking cycles, and patient conversion inertia rather than exclusivity-backed pricing.

How fast is PROGRAF revenue declining, and what market dynamics drive the trajectory?

Quick answer: In mature markets, PROGRAF has shifted from brand-premium growth to a largely mature, contracting profile after generic tacrolimus erosion. The slope of decline depends on (a) which tacrolimus generics are present and interchangeable at the payer level, (b) how quickly pharmacies and hospitals switch NDCs, and (c) whether competing tacrolimus brands or conversion programs (tapering protocols, “conversion to XR” pathways, and procurement bundling) increase share loss.

What share loss looks like post-generic entry

Tacrolimus is a high-volume, chronic immunosuppressant where generics tend to substitute rapidly once manufacturing and supply stabilize. Market behavior typically follows:

• Formulary substitution: Payers often treat tacrolimus generics as therapeutically equivalent for maintenance dosing, driving pricing pressure within 1 to 3 formulary cycles after full generic availability.
• Hospital switching: Transplant centers switch based on protocol compatibility, therapeutic drug monitoring stability, and pharmacy procurement.
• Inventory drawdown: Branded share may temporarily persist due to existing stock, but replenishment tends to align to lowest-cost suppliers.

What keeps branded tacrolimus selling despite generic availability?

PROGRAF’s remaining commercial resilience is tied to operational and clinical factors:

• Dose titration and monitoring workflows that can reduce friction for continued brand use in certain transplant programs.
• Contracting and distribution through major wholesalers and group purchasing organizations.
• Patient continuity: conversion between tacrolimus formulations can require additional monitoring and physician oversight, slowing switching in some subpopulations.

What “product line” factors matter more than exclusivity now?

Even after loss of exclusivity in core markets, lifecycle dynamics still matter:

• Extended-release tacrolimus competition: Competitive claims around once-daily dosing or adherence support can pull share to other tacrolimus platforms depending on local reimbursement.
• US hospital formulary preferences: Many transplant centers prefer a stable, standardized regimen to simplify drug-level monitoring and adherence practices.

What does PROGRAF’s financial trajectory imply for long-term revenue exposure?

Quick answer: PROGRAF’s revenue exposure has transitioned from exclusivity risk to substitution risk. The long-run outlook for brand-level revenue depends less on patent expiration timing and more on ongoing penetration of tacrolimus generics and therapeutic ecosystem shifts across transplant immunosuppression.

Key drivers of revenue pressure

1. Generic pricing compression across tacrolimus strengths and dosage forms.
2. NDC-level cannibalization as wholesalers distribute lowest-cost options.
3. Payer policies that enforce step edits, preferred drug lists, or cost-sharing differentials favoring generics.

Key drivers of residual value (where PROGRAF can still defend)

• Regional formulary heterogeneity: some systems maintain brand preference or less aggressive substitution.
• Contract lock-ins: procurement agreements can delay conversion even when lower-cost equivalents exist.
• Clinical inertia and monitoring capacity: transplant centers with mature PROGRAF monitoring pathways may delay switching.

How does PROGRAF compare with competing tacrolimus products in market dynamics?

Quick answer: The competitive set is dominated by tacrolimus generics and branded alternatives that differ by dosing schedule, formulation characteristics, and payer preference. In practice, tacrolimus “class” competition is the main market story, with brand differentiation often reduced by interchangeability and monitoring protocols.

Competitive categories that influence PROGRAF share

• Generic tacrolimus immediate-release: the dominant substitution engine in most mature geographies.
• Alternative tacrolimus formulations (including extended-release products): compete on convenience and adherence, and sometimes on institutional standardization.
• Other calcineurin inhibitors (indirect competition): while not direct substitutes in every regimen, they can appear in protocol changes, especially where tolerability or nephrotoxicity profiles drive regimen redesign.

What matters for procurement and switching decisions

• Therapeutic drug monitoring compatibility
• Stability of bioavailability during brand-to-generic conversion
• Supply reliability and pack size economics
• Wholesaler and GPO contracting

What patents protect PROGRAF, and when does PROGRAF lose exclusivity?

Insufficient information constraint: A complete, accurate patent-expiration and exclusivity-timeline map requires PROGRAF’s exact US NDA/BLA identifiers, Orange Book listing(s) by dosage form/strength, patent numbers, and assignee-specific prosecution data. The prompt does not include those data, so a definitive expiration schedule and exclusivity-loss statement cannot be produced without risking inaccuracies.

What is the Orange Book status of PROGRAF, and which patents are listed for each dosage form?

Insufficient information constraint: Orange Book status is listing-specific (NDA number, application holders, active ingredients, dosage forms, and Orange Book patent fields). Without the underlying listing identifiers, the requested status and patent-by-dosage-form table cannot be compiled accurately.

What generic entry risks exist for PROGRAF, including Paragraph IV challenges?

Insufficient information constraint: Paragraph IV litigation risk is tied to filed ANDAs and their listed patents. Without ANDA/Paragraph IV docket data for PROGRAF, the body cannot provide a factual account of current or historical challenge activity.

What patent litigation affects PROGRAF, and how have settlements shaped market outcomes?

Insufficient information constraint: Litigation outcomes require docket identifiers, court venues, settlement dates, and stipulation terms (including potential “carve-outs” by dosage form). Those facts are not provided, so an accurate litigation-impact section cannot be produced.

How does FDA regulatory status shape PROGRAF market access and switching?

Insufficient information constraint: FDA regulatory status by pathway (NDA history, supplements, pediatric exclusivity, approval letters, and current label status) is listing-specific. The prompt does not include PROGRAF’s application identifiers and current label/approval history.

Which companies compete with PROGRAF in tacrolimus immunosuppression?

Insufficient information constraint: A reliable competitive-actor list (specific generic manufacturers with dominant share, branded alternative sponsors, and market leaders by geography) requires current market share data and/or distribution analytics that are not included in the prompt.

What are the commercial metrics that best explain PROGRAF financial performance?

Insufficient information constraint: The prompt asks for “financial trajectory,” which requires at minimum: annual sales figures by geography (or at least US), revenue by year (or segments), and pricing/unit metrics. Those figures are not provided in the prompt.

Key Takeaways

• PROGRAF’s commercial profile is primarily shaped by generic substitution dynamics in tacrolimus immunosuppression, not by brand exclusivity.
• Revenue trajectory in mature markets is typically declining and then stabilizing at lower branded levels as formulary penetration and procurement shift toward generics.
• Residual branded value is usually defended through contracting, institutional inertia, and monitoring workflows, not patent-backed pricing power.
• A defensible patent and regulatory exclusivity timeline for PROGRAF requires Orange Book listing-level data and application identifiers, which are not present in the provided input.

FAQs

1. What factors determine whether a transplant center switches from PROGRAF to generic tacrolimus?
2. How do payer step edits and copay tiers influence PROGRAF vs generic tacrolimus uptake?
3. How does once-daily extended-release tacrolimus competition affect PROGRAF prescribing patterns?
4. What supply-chain and procurement variables most affect branded tacrolimus remaining share?
5. How do therapeutic drug monitoring protocols change during tacrolimus brand-to-generic conversion?

References

1. (No sourceable citations available from the provided prompt.)

DrugChatter Q&A for PROGRAF

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