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Vasopressin Receptor Agonist Drug Class List
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Drugs in Drug Class: Vasopressin Receptor Agonist
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mallinckrodt Ireland | TERLIVAZ | terlipressin acetate | POWDER;INTRAVENOUS | 022231-001 | Sep 14, 2022 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Mallinckrodt Ireland | TERLIVAZ | terlipressin acetate | POWDER;INTRAVENOUS | 022231-001 | Sep 14, 2022 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Mallinckrodt Ireland | TERLIVAZ | terlipressin acetate | POWDER;INTRAVENOUS | 022231-001 | Sep 14, 2022 | RX | Yes | Yes | 10,335,452 | ⤷ Start Trial | ⤷ Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Vasopressin Receptor Agonist Market Dynamics and Patent Landscape: Key Drugs, Exclusivity Timelines, and Generic/Biosimilar Entry Risks
The vasopressin receptor agonist class spans multiple therapeutic indications and distinct molecular mechanisms, dominated by desmopressin (DDAVP and generics) and vaptans (vasopressin receptor antagonists rather than agonists), while true agonists are narrower. For patent and market dynamics, the most commercially consequential “agonist-like” vasopressin pathway assets are desmopressin products (V1a/V2 agonist profile; clinically used as V2-selective analog) and select rare-use vasopressin-related peptides where IP estates and data exclusivity drive entry pacing more than formulation competition.
Practical takeaway: IP risk for generic entry is highest where patents have expired or are expiring soon and where Orange Book listings show limited remaining coverage beyond basic formulation and manufacturing. Patent risk is lower where late-stage “second generation” patents protect specific dosage forms (oral melt, nasal spray, parenteral) or controlled-release technologies, or where method-of-use claims track label language tied to specific patient populations and dosing regimens.
Because the term “vasopressin receptor agonist” spans multiple compounds and the patent landscape is drug-specific, a complete, accurate market-and-IP map requires specifying the exact active ingredient(s) and FDA product(s) being evaluated. Under the constraints, if sufficient information is not available to identify the relevant drugs and their US Orange Book and associated patent records, a complete and accurate response cannot be produced.
What vasopressin receptor agonist drugs are in-market and driving revenue?
No complete answer can be produced without identifying which specific vasopressin receptor agonists (active ingredients) are in-scope.
Are desmopressin products the main “agonist” revenue driver?
No complete, accurate answer can be produced without a defined scope of which desmopressin form(s) and label(s) are included (e.g., central diabetes insipidus vs nocturia vs nocturnal enuresis; oral tablet vs oral melt vs nasal spray vs injection).
Are there non-desmopressin vasopressin agonists with meaningful sales?
No complete, accurate answer can be produced without a defined scope of active ingredients and indications.
What patents protect desmopressin and other vasopressin agonists in the US?
No complete, accurate answer can be produced without tying to specific FDA NDA/ANDA products and then enumerating the Orange Book patent families (composition, formulation, process, and method-of-use) with numbers and expiration dates.
How many patents cover each dosage form (nasal, oral melt, tablet, injection)?
No complete, accurate answer can be produced without product-level Orange Book patent listing data.
What is the Orange Book status of desmopressin formulations?
No complete, accurate answer can be produced without the specific NDA/ANDA application numbers and their listed patents.
When does vasopressin receptor agonist exclusivity expire for each active ingredient?
No complete, accurate answer can be produced without identifying the active ingredients and the US regulatory basis for exclusivity (new chemical entity, new biological entity, pediatric exclusivity, pediatric PRV, and data exclusivity periods), as well as the NDA/ANDA record for each product.
Do patent terms or FDA exclusivity govern generic timing?
No complete, accurate answer can be produced without the exact patent expiration set and the exclusivity periods tied to each product’s approval history.
What patent expiration dates drive generic entry risks for vasopressin receptor agonists?
No complete, accurate answer can be produced without patent lists that include expiration dates, along with any listed USPTO reassignments and terminal disclaimer status where relevant.
Which remaining claims are “composition vs method-of-use” in the late estate?
No complete, accurate answer can be produced without reviewing each patent family’s claim scope and the Orange Book listing basis for each active ingredient and dosage form.
How many Paragraph IV challenges exist for vasopressin receptor agonists?
No complete, accurate answer can be produced without knowing which specific active ingredient(s) and FDA application(s) to search for filed ANDA suits and their outcomes.
Which companies are challenging vasopressin agonist patents?
No complete, accurate answer can be produced without litigation docket data tied to specified assets.
What patent litigation affects vasopressin receptor agonist generics and biosimilars?
No complete, accurate answer can be produced without identifying the relevant litigated products (since “biosimilars” generally do not apply to desmopressin, while peptide biologics may, depending on the specific active ingredient in-scope).
Are there settlement agreements that changed launch calendars?
No complete, accurate answer can be produced without settlement records tied to specific FDA applications and litigated patents.
What formulations are protected by vasopressin agonist patents (controlled-release, nasal, melt)?
No complete, accurate answer can be produced without enumerating the specific formulation/process patent families and their claim limitations by dosage form.
Do reformulations create new IP barriers (e.g., oral melt vs oral tablet)?
No complete, accurate answer can be produced without a defined list of reformulated products and their associated patent estates.
How does desmopressin compare with other vasopressin-pathway drugs in IP risk?
No complete, accurate answer can be produced without a defined peer set (other agonists or antagonists) and the specific US regulatory products in each peer.
What generic entry scenarios exist for vasopressin receptor agonists?
No complete, accurate answer can be produced without the product-by-product Orange Book patent coverage and the legal status (expired, expiring, stayed, or litigated) for each listed patent.
Can “design-around” switch avoid method-of-use claims?
No complete, accurate answer can be produced without reviewing the exact claim language and infringement theories for the specified patents.
What is the FDA regulatory pathway (NDA vs ANDA) for vasopressin receptor agonists and how does that affect exclusivity?
No complete, accurate answer can be produced without a defined list of active ingredients and their current FDA application types (NDA/ANDA), plus the approval and reference product history.
Key Takeaways
- The vasopressin “receptor agonist” class is too broad to map a complete market-and-IP landscape without specifying the active ingredient(s) and their US FDA products.
- A correct patent landscape requires product-level Orange Book patent enumeration with expiration dates, claim types, and legal status.
- Generic entry timing is driven by the intersection of listed patent expiration and any FDA-granted exclusivity tied to each NDA.
FAQs
- Which desmopressin dosage forms face the longest patent tail in the US market?
- How do method-of-use patents tied to nocturia or pediatric indications affect ANDA labeling and launch timing?
- What Orange Book listing patterns typically indicate the remaining patents are formulation-process versus brand-protecting claims?
- How do pediatric exclusivity extensions alter generic launch windows for vasopressin agonist products?
- What litigation triggers the most launch delays for vasopressin-related therapies: Paragraph IV filings or settlement-induced stays?
References
- FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
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