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Orange Book drug · Brand (NDA)

Epaned

Enalapril Maleate

RLDNDA 208686 Azurity
Approved
Sep 20, 2016
Strengths
1
Listed patents
9

What does the FDA Orange Book show for Epaned?

Epaned contains Enalapril Maleate and is the new drug FDA Orange Book record for NDA 208686. The application has 1 presentation with strength, dosage-form, route, status, RLD/RS, TE, patent, and exclusivity context. Current inventory and clinical labeling are not established without an application-matched source.

FDA application
NDA 208686

New drug application identity from the Orange Book snapshot.

Application holder
Azurity Pharmaceuticals 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
9

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
0011MG/MLSOLUTIONORALPrescriptionAB
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

Azurity Pharmaceuticals Inc

The Orange Book identifies this organization as the applicant responsible for NDA 208686.

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

9 listed patent expirations and 0 exclusivity dates remain on or after Jul 26, 2026

The latest future date recorded across those files is Mar 25, 2036. Patent and FDA exclusivity operate independently, can overlap, and do not by themselves predict a generic launch date.

Same-ingredient landscape

23 other ANDAs and 2 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 208686 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-208686

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 208686
TE ABRLDRS
Strength
1MG/ML
Dosage form
SOLUTION
Route
ORAL
Marketing status
Prescription

Key dates

Approval, patents, exclusivity

  1. Approval

    FDA approval date of this drug product.

    10 yr ago

  2. Today

  3. Patent 10039745 expires

    Listed drug product patent expiration.

    in 9 yr 10 mo

  4. Patent 10154987 expires

    Listed method-of-use patent (U-3) expiration.

    in 9 yr 10 mo

  5. Patent 10154987 expires

    Listed method-of-use patent (U-1892) expiration.

    in 9 yr 10 mo

  6. Patent 10154987 expires

    Listed method-of-use patent (U-185) expiration.

    in 9 yr 10 mo

  7. Patent 10154987 expires

    Listed method-of-use patent (U-71) expiration.

    in 9 yr 10 mo

  8. Patent 10154987 expires

    Listed method-of-use patent (U-1723) expiration.

    in 9 yr 10 mo

  9. Patent 10772868 expires

    Listed drug product patent expiration.

    in 9 yr 10 mo

  10. Patent 10786482 expires

    Listed drug product patent expiration.

    in 9 yr 10 mo

  11. Patent 11040023 expires

    Listed drug product patent expiration.

    in 9 yr 10 mo

  12. Patent 11141405 expires

    Listed drug product patent expiration.

    in 9 yr 10 mo

  13. Patent 11173141 expires

    Listed drug product patent expiration.

    in 9 yr 10 mo

  14. Patent 9669008 expires

    Listed drug product patent expiration.

    in 9 yr 10 mo

  15. Patent 9808442 expires

    Listed method-of-use patent (U-71) expiration.

    in 9 yr 10 mo

  16. Patent 9808442 expires

    Listed method-of-use patent (U-1723) expiration.

    in 9 yr 10 mo

  17. Patent 9808442 expires

    Listed method-of-use patent (U-185) expiration.

    in 9 yr 10 mo

  18. Patent 9808442 expires

    Listed method-of-use patent (U-1892) expiration.

    in 9 yr 10 mo

  19. Patent 9808442 expires

    Listed method-of-use patent (U-3) expiration.

    in 9 yr 10 mo

Patent & exclusivity timeline

Protection horizon
202620282030203220342036TodayPatent 10039745: 2036-03-25Patent 10039745Patent 10154987: 2036-03-25Patent 10154987Patent 10154987: 2036-03-25Patent 10154987Patent 10154987: 2036-03-25Patent 10154987Patent 10154987: 2036-03-25Patent 10154987Patent 10154987: 2036-03-25Patent 10154987Patent 10772868: 2036-03-25Patent 10772868Patent 10786482: 2036-03-25Patent 10786482Patent 11040023: 2036-03-25Patent 11040023Patent 11141405: 2036-03-25Patent 11141405Patent 11173141: 2036-03-25Patent 11173141Patent 9669008: 2036-03-25Patent 9669008Patent 9808442: 2036-03-25Patent 9808442Patent 9808442: 2036-03-25Patent 9808442Patent 9808442: 2036-03-25Patent 9808442Patent 9808442: 2036-03-25Patent 9808442Patent 9808442: 2036-03-25Patent 9808442
Patent expiryExclusivity endToday

Pharmaceutical detail

FDA product record

Active ingredient

ENALAPRIL MALEATE

Strength

1MG/ML

Dosage form

SOLUTION

Route

ORAL

TE code

AB

Application

NDA 208686

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
10039745in 9 yr 10 mo
Product
10154987in 9 yr 10 mo
U-3
10154987in 9 yr 10 mo
U-1892
10154987in 9 yr 10 mo
U-185
10154987in 9 yr 10 mo
U-71
10154987in 9 yr 10 mo
U-1723
10772868in 9 yr 10 mo
Product
10786482in 9 yr 10 mo
Product
11040023in 9 yr 10 mo
Product
11141405in 9 yr 10 mo
Product
11173141in 9 yr 10 mo
Product
9669008in 9 yr 10 mo
Product
9808442in 9 yr 10 mo
U-71
9808442in 9 yr 10 mo
U-1723
9808442in 9 yr 10 mo
U-185
9808442in 9 yr 10 mo
U-1892
9808442in 9 yr 10 mo
U-3

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 Enalapril Maleate 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.

Epaned: 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 208686 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.

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