FDA application holder
Mayne Pharma LLC
The Orange Book identifies this organization as the applicant responsible for NDA 208564.
Orange Book drug · Brand (NDA)
Imvexxy
Estradiol
RLDNDA 208564 2 strengths Mayne Pharma
Approved
May 29, 2018
Strengths
2
Listed patents
20
What does the FDA Orange Book show for Imvexxy?
Imvexxy contains Estradiol and is the new drug FDA Orange Book record for NDA 208564. The application has 2 presentations 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 208564
- Application holder
- Mayne Pharma LLC
- Product presentations
- 2
- Marketing categories
- Prescription
- Reference roles
- RLD / RS
- TE codes
- AB
- Listed patents
- 20
- Exclusivity records
- 0
New drug application identity from the Orange Book snapshot.
The listed applicant holds the FDA application; this field does not establish the product manufacturer.
Each FDA product number remains tied to its own strength, dosage form, route, and status.
Orange Book marketing categories do not establish real-time inventory or commercial availability.
RLD and RS designations are presentation-specific, not inferred from the trade name.
Therapeutic-equivalence codes apply only within the matching Orange Book product heading.
A zero means none appear in this snapshot, not that no patent rights exist.
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
| Product | Strength | Dosage form / route | Marketing status | TE code | Reference role |
|---|---|---|---|---|---|
| 001 | 0.004MG | INSERTVAGINAL | Prescription | AB | RLDRS |
| 002 | 0.01MG | INSERTVAGINAL | Prescription | AB | 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
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
2 presentations 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
20 listed patent expirations and 0 exclusivity dates remain on or after Jul 26, 2026
The latest future date recorded across those files is Feb 02, 2034. Patent and FDA exclusivity operate independently, can overlap, and do not by themselves predict a generic launch date.
Same-ingredient landscape
41 other ANDAs and 16 other NDAs found
32 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 208564 appears in 1 comparison cohort. These groups narrow the same-ingredient landscape, but strength and TE code must still match before interpreting therapeutic equivalence.
Insert · Vaginal
Estradiol
- Product rows
- 4
- Active applications
- 2
- Active with AB row
- 2
Why are clinical sections unavailable?
Exact application-label matching status
Exact source match queuedQueue NDA-208564
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.
Strengths & dosage forms
2 approved presentations · NDA 208564
TE ABRLDRS
- Strength
- 0.004MG
- Dosage form
- INSERT
- Route
- VAGINAL
- Marketing status
- Prescription
Key dates
Approval, patents, exclusivityApproval
FDA approval date of this drug product.
8 yr 3 mo ago
Today
Patent 10258630 expires
Listed method-of-use patent (U-2316) expiration.
in 6 yr 5 mo
Patent 10258630 expires
Listed method-of-use patent (U-2317) expiration.
in 6 yr 5 mo
Patent 10398708 expires
Listed method-of-use patent (U-2317) expiration.
in 6 yr 5 mo
Patent 10398708 expires
Listed method-of-use patent (U-2614) expiration.
in 6 yr 5 mo
Patent 10471072 expires
Listed method-of-use patent (U-2317) expiration.
in 6 yr 5 mo
Patent 10471072 expires
Listed method-of-use patent (U-2316) expiration.
in 6 yr 5 mo
Patent 10537581 expires
Listed drug product patent expiration.
in 6 yr 5 mo
Patent 10537581 expires
Listed drug product patent expiration.
in 6 yr 5 mo
Patent 10568891 expires
Listed method-of-use patent (U-2316) expiration.
in 6 yr 5 mo
Patent 10568891 expires
Listed method-of-use patent (U-2317) expiration.
in 6 yr 5 mo
Patent 10668082 expires
Listed method-of-use patent (U-2317) expiration.
in 6 yr 5 mo
Patent 10668082 expires
Listed method-of-use patent (U-2316) expiration.
in 6 yr 5 mo
Patent 10806697 expires
Listed drug product patent expiration.
in 6 yr 5 mo
Patent 10835487 expires
Listed method-of-use patent (U-2316) expiration.
in 6 yr 5 mo
Patent 10835487 expires
Listed method-of-use patent (U-2317) expiration.
in 6 yr 5 mo
Patent 10888516 expires
Listed method-of-use patent (U-2316) expiration.
in 6 yr 5 mo
Patent 10888516 expires
Listed method-of-use patent (U-2317) expiration.
in 6 yr 5 mo
Patent 11065197 expires
Listed drug product patent expiration.
in 6 yr 5 mo
Patent 11116717 expires
Listed drug product patent expiration.
in 6 yr 5 mo
Patent 11123283 expires
Listed drug product patent expiration.
in 6 yr 5 mo
Patent 11241445 expires
Listed method-of-use patent (U-2316) expiration.
in 6 yr 5 mo
Patent 11241445 expires
Listed method-of-use patent (U-2317) expiration.
in 6 yr 5 mo
Patent 11246875 expires
Listed method-of-use patent (U-2316) expiration.
in 6 yr 5 mo
Patent 11246875 expires
Listed method-of-use patent (U-2317) expiration.
in 6 yr 5 mo
Patent 11304959 expires
Listed drug product patent expiration.
in 6 yr 5 mo
Patent 11351182 expires
Listed method-of-use patent (U-2316) expiration.
in 6 yr 5 mo
Patent 11351182 expires
Listed method-of-use patent (U-2317) expiration.
in 6 yr 5 mo
Patent 9180091 expires
Listed drug product patent expiration.
in 6 yr 5 mo
Patent 9180091 expires
Listed drug product patent expiration.
in 6 yr 5 mo
Patent 9289382 expires
Listed drug product patent expiration.
in 6 yr 5 mo
Patent 11266661 expires
Listed method-of-use patent (U-2316) expiration.
in 7 yr 8 mo
Patent 11266661 expires
Listed method-of-use patent (U-2317) expiration.
in 7 yr 8 mo
Patent & exclusivity timeline
Protection horizonPatent expiryExclusivity endToday
Pharmaceutical detail
FDA product recordActive ingredient
ESTRADIOL
Strength
0.004MG
Dosage form
INSERT
Route
VAGINAL
TE code
AB
Application
NDA 208564
Product number
001
Marketing status
Prescription
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Listed patents
Orange Book patent file| Patent | Expires | In | Type |
|---|---|---|---|
| 10258630 | in 6 yr 5 mo | U-2316 | |
| 10258630 | in 6 yr 5 mo | U-2317 | |
| 10398708 | in 6 yr 5 mo | U-2317 | |
| 10398708 | in 6 yr 5 mo | U-2614 | |
| 10471072 | in 6 yr 5 mo | U-2317 | |
| 10471072 | in 6 yr 5 mo | U-2316 | |
| 10537581 | in 6 yr 5 mo | ProductU-2316 | |
| 10537581 | in 6 yr 5 mo | ProductU-2317 | |
| 10568891 | in 6 yr 5 mo | U-2316 | |
| 10568891 | in 6 yr 5 mo | U-2317 | |
| 10668082 | in 6 yr 5 mo | U-2317 | |
| 10668082 | in 6 yr 5 mo | U-2316 | |
| 10806697 | in 6 yr 5 mo | Product | |
| 10835487 | in 6 yr 5 mo | U-2316 | |
| 10835487 | in 6 yr 5 mo | U-2317 | |
| 10888516 | in 6 yr 5 mo | U-2316 | |
| 10888516 | in 6 yr 5 mo | U-2317 | |
| 11065197 | in 6 yr 5 mo | Product | |
| 11116717 | in 6 yr 5 mo | Product | |
| 11123283 | in 6 yr 5 mo | Product | |
| 11241445 | in 6 yr 5 mo | U-2316 | |
| 11241445 | in 6 yr 5 mo | U-2317 | |
| 11246875 | in 6 yr 5 mo | U-2316 | |
| 11246875 | in 6 yr 5 mo | U-2317 | |
| 11304959 | in 6 yr 5 mo | Product | |
| 11351182 | in 6 yr 5 mo | U-2316 | |
| 11351182 | in 6 yr 5 mo | U-2317 | |
| 9180091 | in 6 yr 5 mo | ProductU-2317 | |
| 9180091 | in 6 yr 5 mo | ProductU-2316 | |
| 9289382 | in 6 yr 5 mo | Product | |
| 11266661 | in 7 yr 8 mo | U-2316 | |
| 11266661 | in 7 yr 8 mo | U-2317 |
TE ABRLDRS
- Strength
- 0.01MG
- Dosage form
- INSERT
- Route
- VAGINAL
- Marketing status
- Prescription
Key dates
Approval, patents, exclusivityApproval
FDA approval date of this drug product.
8 yr 3 mo ago
Today
Patent 10258630 expires
Listed method-of-use patent (U-2316) expiration.
in 6 yr 5 mo
Patent 10258630 expires
Listed method-of-use patent (U-2317) expiration.
in 6 yr 5 mo
Patent 10398708 expires
Listed method-of-use patent (U-2317) expiration.
in 6 yr 5 mo
Patent 10398708 expires
Listed method-of-use patent (U-2614) expiration.
in 6 yr 5 mo
Patent 10471072 expires
Listed method-of-use patent (U-2317) expiration.
in 6 yr 5 mo
Patent 10471072 expires
Listed method-of-use patent (U-2316) expiration.
in 6 yr 5 mo
Patent 10537581 expires
Listed drug product patent expiration.
in 6 yr 5 mo
Patent 10537581 expires
Listed drug product patent expiration.
in 6 yr 5 mo
Patent 10568891 expires
Listed method-of-use patent (U-2317) expiration.
in 6 yr 5 mo
Patent 10568891 expires
Listed method-of-use patent (U-2316) expiration.
in 6 yr 5 mo
Patent 10668082 expires
Listed method-of-use patent (U-2316) expiration.
in 6 yr 5 mo
Patent 10668082 expires
Listed method-of-use patent (U-2317) expiration.
in 6 yr 5 mo
Patent 10806697 expires
Listed drug product patent expiration.
in 6 yr 5 mo
Patent 10835487 expires
Listed method-of-use patent (U-2317) expiration.
in 6 yr 5 mo
Patent 10835487 expires
Listed method-of-use patent (U-2316) expiration.
in 6 yr 5 mo
Patent 10888516 expires
Listed method-of-use patent (U-2316) expiration.
in 6 yr 5 mo
Patent 10888516 expires
Listed method-of-use patent (U-2317) expiration.
in 6 yr 5 mo
Patent 11065197 expires
Listed drug product patent expiration.
in 6 yr 5 mo
Patent 11116717 expires
Listed drug product patent expiration.
in 6 yr 5 mo
Patent 11123283 expires
Listed drug product patent expiration.
in 6 yr 5 mo
Patent 11241445 expires
Listed method-of-use patent (U-2317) expiration.
in 6 yr 5 mo
Patent 11241445 expires
Listed method-of-use patent (U-2316) expiration.
in 6 yr 5 mo
Patent 11246875 expires
Listed method-of-use patent (U-2317) expiration.
in 6 yr 5 mo
Patent 11246875 expires
Listed method-of-use patent (U-2316) expiration.
in 6 yr 5 mo
Patent 11304959 expires
Listed drug product patent expiration.
in 6 yr 5 mo
Patent 11351182 expires
Listed method-of-use patent (U-2316) expiration.
in 6 yr 5 mo
Patent 11351182 expires
Listed method-of-use patent (U-2317) expiration.
in 6 yr 5 mo
Patent 11497709 expires
Listed method-of-use patent (U-2316) expiration.
in 6 yr 5 mo
Patent 11497709 expires
Listed method-of-use patent (U-2317) expiration.
in 6 yr 5 mo
Patent 9180091 expires
Listed drug product patent expiration.
in 6 yr 5 mo
Patent 9180091 expires
Listed drug product patent expiration.
in 6 yr 5 mo
Patent 9289382 expires
Listed drug product patent expiration.
in 6 yr 5 mo
Patent 11266661 expires
Listed method-of-use patent (U-2316) expiration.
in 7 yr 8 mo
Patent 11266661 expires
Listed method-of-use patent (U-2317) expiration.
in 7 yr 8 mo
Patent & exclusivity timeline
Protection horizonPatent expiryExclusivity endToday
Pharmaceutical detail
FDA product recordActive ingredient
ESTRADIOL
Strength
0.01MG
Dosage form
INSERT
Route
VAGINAL
TE code
AB
Application
NDA 208564
Product number
002
Marketing status
Prescription
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Listed patents
Orange Book patent file| Patent | Expires | In | Type |
|---|---|---|---|
| 10258630 | in 6 yr 5 mo | U-2316 | |
| 10258630 | in 6 yr 5 mo | U-2317 | |
| 10398708 | in 6 yr 5 mo | U-2317 | |
| 10398708 | in 6 yr 5 mo | U-2614 | |
| 10471072 | in 6 yr 5 mo | U-2317 | |
| 10471072 | in 6 yr 5 mo | U-2316 | |
| 10537581 | in 6 yr 5 mo | ProductU-2317 | |
| 10537581 | in 6 yr 5 mo | ProductU-2316 | |
| 10568891 | in 6 yr 5 mo | U-2317 | |
| 10568891 | in 6 yr 5 mo | U-2316 | |
| 10668082 | in 6 yr 5 mo | U-2316 | |
| 10668082 | in 6 yr 5 mo | U-2317 | |
| 10806697 | in 6 yr 5 mo | Product | |
| 10835487 | in 6 yr 5 mo | U-2317 | |
| 10835487 | in 6 yr 5 mo | U-2316 | |
| 10888516 | in 6 yr 5 mo | U-2316 | |
| 10888516 | in 6 yr 5 mo | U-2317 | |
| 11065197 | in 6 yr 5 mo | Product | |
| 11116717 | in 6 yr 5 mo | Product | |
| 11123283 | in 6 yr 5 mo | Product | |
| 11241445 | in 6 yr 5 mo | U-2317 | |
| 11241445 | in 6 yr 5 mo | U-2316 | |
| 11246875 | in 6 yr 5 mo | U-2317 | |
| 11246875 | in 6 yr 5 mo | U-2316 | |
| 11304959 | in 6 yr 5 mo | Product | |
| 11351182 | in 6 yr 5 mo | U-2316 | |
| 11351182 | in 6 yr 5 mo | U-2317 | |
| 11497709 | in 6 yr 5 mo | U-2316 | |
| 11497709 | in 6 yr 5 mo | U-2317 | |
| 9180091 | in 6 yr 5 mo | ProductU-2317 | |
| 9180091 | in 6 yr 5 mo | ProductU-2316 | |
| 9289382 | in 6 yr 5 mo | Product | |
| 11266661 | in 7 yr 8 mo | U-2316 | |
| 11266661 | in 7 yr 8 mo | U-2317 |
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.
- 2014MinivelleBrand (NDA)
NDA 203752 · Noven
- 2009VagifemBrand (NDA)
NDA 020908 · Novo Nordisk Inc
- 2007EvamistBrand (NDA)
NDA 022014 · Padagis US
- 2007DivigelBrand (NDA)
NDA 022038 · Vertical Pharms
- 2006ElestrinBrand (NDA)
NDA 021813 · Viatris
- 2004MenostarBrand (NDA)
NDA 021674 · Bayer Hlthcare
- 2004EstrogelBrand (NDA)
NDA 021166 · Ascend Theraps US
- 2002Vivelle-dotBrand (NDA)
NDA 020538 · Sandoz
- 2002AloraBrand (NDA)
NDA 020655 · Abbvie
- 2000VivelleBrand (NDA)
NDA 020323 · Sandoz
- 1999EstradiolBrand (NDA)
NDA 021048 · Ortho Mcneil Pharm
- 1999ClimaraBrand (NDA)
NDA 020375 · Bayer Hlthcare
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
- Electronic Orange Book record
- Orange Book preface and TE-code policy
- FDA product, patent, and exclusivity data files
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.
Imvexxy: 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 208564 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
