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Orange Book drug · Brand (NDA)

Kuvan

Sapropterin Dihydrochloride

RLDNDA 022181 Biomarin Pharm
Approved
Dec 13, 2007
Strengths
1
Listed patents
4
Applications
2

What does the FDA Orange Book show for Kuvan?

Kuvan contains Sapropterin Dihydrochloride and appears in 2 FDA Orange Book applications. NDA 022181 is the lead filing, with 1 presentation shown in detail; the other exact-name filings are listed separately. The page preserves strength, dosage form, route, status, RLD/RS, TE, patent, and exclusivity facts. Clinical labeling requires an exact application-matched source.

FDA applications
2; lead NDA 022181

Every filing shown uses the exact FDA product name; the lead filing supplies the detailed presentation view.

Lead application holder
Biomarin Pharmaceutical Inc

The listed applicant holds the FDA application; this field does not establish the product manufacturer.

Product presentations
1

Each FDA product number remains tied to its own strength, dosage form, route, and status.

Marketing categories
Prescription

Orange Book marketing categories do not establish real-time inventory or commercial availability.

Reference roles
RLD / RS

RLD and RS designations are presentation-specific, not inferred from the trade name.

TE codes
AB

Therapeutic-equivalence codes apply only within the matching Orange Book product heading.

Listed patents
4

A zero means none appear in this snapshot, not that no patent rights exist.

Exclusivity records
0

FDA exclusivity and listed patent protection are distinct regulatory concepts.

Sourced from the official FDA Orange Book data file · snapshot refreshed

FDA product-presentation matrix

Every product number in this exact application
Every FDA product presentation under this application, with strength, dosage form and route, marketing status, therapeutic-equivalence code, and reference role.
ProductStrengthDosage form / routeMarketing statusTE codeReference role
001100MGTABLETORALPrescriptionAB
RLDRS

Marketing status, TE code, RLD, and RS are presentation-level fields. Never transfer one product number's designation to another presentation.

Who is responsible for this application?

Application holder is not the same as manufacturer

FDA application holder

Biomarin Pharmaceutical Inc

The Orange Book identifies this organization as the applicant responsible for NDA 022181.

Manufacturer status

Not established by the Orange Book

A product-specific FDA label or NDC source must independently identify a manufacturer, labeler, distributor, packager, repackager, or relabeler. The applicant name is not used as a substitute for that evidence.

Regulatory interpretation

What the record means, and what it does not
FDA marketing status

1 presentation listed as prescription

RX and OTC are Orange Book marketing categories, not real-time inventory signals. Confirm current commercial availability with labeling, the application holder, or an authoritative drug listing.

Therapeutic equivalence

TE code AB across rated presentations

An AB code is an A-rating: FDA considers the product therapeutically equivalent to pharmaceutical equivalents in the same Orange Book heading and equivalence group.

Patent & exclusivity record

No future patent-expiry or exclusivity dates are recorded

The snapshot contains 4 listed patents and 0 exclusivity records, but none has a date on or after Jul 26, 2026. This is not a legal conclusion that the product is unprotected.

Same-ingredient landscape

13 other ANDAs and 0 other NDAs found

13 of the related ANDA applications are not marked discontinued. Sharing an ingredient does not establish pharmaceutical or therapeutic equivalence; strength, dosage form, route, and TE group still matter.

Which products are meaningfully comparable?

Exact ingredient + dosage form + route cohorts

NDA 022181 appears in 1 comparison cohort. These groups narrow the same-ingredient landscape, but strength and TE code must still match before interpreting therapeutic equivalence.

Why are clinical sections unavailable?

Exact application-label matching status
Exact source match queuedQueue NDA-022181

No exact application-level FDA or DailyMed label match has been reviewed for this application. Approved uses, dosing, warnings, adverse reactions, and clinical evidence remain unavailable rather than being inherited from a related brand, generic, or ingredient record.

Until an exact application match passes human review, this page intentionally omits approved uses, dosing, warnings, adverse reactions, mechanism, and clinical-study summaries. It never inherits those claims from an RLD, brand, generic, or same-ingredient product.

Product detail

NDA 022181
TE ABRLDRS
Strength
100MG
Dosage form
TABLET
Route
ORAL
Marketing status
Prescription

Key dates

Approval, patents, exclusivity

  1. Approval

    FDA approval date of this drug product.

    18 yr 11 mo ago

  2. Patent 7566462 expires

    Listed drug product patent expiration.

    8 mo ago

  3. Patent 8003126 expires

    Listed listed patent expiration.

    8 mo ago

  4. Patent 7566462*PED expires

    Listed listed patent expiration.

    2 mo ago

  5. Patent 8003126*PED expires

    Listed listed patent expiration.

    2 mo ago

  6. Today

Patent & exclusivity timeline

Protection horizon
202520262027TodayPatent 7566462: 2025-11-16Patent 7566462Patent 8003126: 2025-11-16Patent 8003126Patent 7566462*PED: 2026-05-16Patent 7566462*PEDPatent 8003126*PED: 2026-05-16Patent 8003126*PED
Patent expiryExclusivity endToday

Pharmaceutical detail

FDA product record

Active ingredient

SAPROPTERIN DIHYDROCHLORIDE

Strength

100MG

Dosage form

TABLET

Route

ORAL

TE code

AB

Application

NDA 022181

Product number

001

Marketing status

Prescription

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Listed patents

Orange Book patent file
Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
75664628 mo ago
Product
80031268 mo ago
7566462*PED2 mo ago
8003126*PED2 mo ago

Other FDA applications for Kuvan

1 additional filing

The FDA has approved 2 separate applications under this product name. Each row is one application: a distinct applicant and approval for the same drug.

Other FDA applications approved under the product name Kuvan, with applicant, approval date, number of strengths, therapeutic-equivalence code, and marketing status.
ApplicationApplicantApprovedStrengthsTE codeStatus
NDA 205065Biomarin PharmDec 19, 20132ABPrescription

Active-ingredient family

Brand + generics

This is a reference-listed drug (RLD), the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

View full Sapropterin Dihydrochloride family

How to use this record responsibly

Scope, limitations, and primary sources

What to verify before making a decision

  • The applicant is the holder of legal responsibility for the application; the Orange Book does not establish that the applicant manufactured or currently markets every listed product.
  • RX, OTC, and discontinued are FDA listing categories, not real-time pharmacy inventory or commercial-availability data.
  • Therapeutic equivalence applies only within the matching ingredient, dosage form, route, strength, and TE-code group; same ingredient alone is insufficient.
  • Listed patent and exclusivity dates are regulatory intelligence, not legal advice, a freedom-to-operate analysis, or a reliable generic-launch forecast.
  • The Orange Book is not prescribing information and does not provide indications, dosing, contraindications, adverse reactions, recalls, or current safety communications.

Official FDA references

Data shown here is normalized for search and comparison. When a regulatory, substitution, launch, or legal decision turns on a field, verify it against the current FDA record and the relevant source document.

Kuvan: frequently asked questions

Approval, therapeutic equivalence, patents, and exclusivity for this drug, from the FDA Orange Book.

Built directly from the FDA Orange Book product, patent, and exclusivity files refreshed Jul 02, 2026, 06:34 PM. Every strength of NDA 022181 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.

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