Litigation Details for NORWICH PHARMACEUTICALS, INC. v. BECERRA (D.D.C. 2023)

NORWICH PHARMACEUTICALS, INC. v. BECERRA (D.D.C. 2023)

Docket		Date Filed	2023-06-05
Court	District Court, District of Columbia	Date Terminated	2023-12-04
Cause	05:702 Administrative Procedure Act	Assigned To	Randolph Daniel Moss
Jury Demand	None	Referred To
Patents	10,314,828; 10,335,397; 10,456,384; 10,703,763; 10,709,694; 10,765,667; 11,564,912; 6,861,053; 7,045,620; 7,612,199; 7,902,206; 7,906,542; 7,915,275; 8,158,644; 8,158,781; 8,193,196; 8,309,569; 8,518,949; 8,642,573; 8,741,904; 8,829,017; 8,835,452; 8,853,231; 8,946,252; 8,969,398; 9,271,968; 9,421,195; 9,623,001; 9,629,828
Link to Docket	External link to docket

Details for NORWICH PHARMACEUTICALS, INC. v. BECERRA (D.D.C. 2023)

Date Filed	Document No.	Description	Snippet	Link To Document
2023-06-05				External link to document
2023-06-05	1	Exhibit 1	(the 9'828 patent) July 24, 2029 10,314,828 (the 4'828 patent) July 24, 2029 …550 mg, is subject to periods of patent protection. The following patents and expiration dates are currently… U.S. Patent Number Expiration Date 7,045,620 (the '620 patent) June…7,612,199 (the '199 patent) June 19, 2024 7,902,206 (the '206 patent) June 19, 2024…7,906,542 (the '542 patent) June 1, 2025 7,915,275 (the '275 patent) February 23,	External link to document
2023-06-05	12	Exhibit Complaint	(last visited Jun. 4, 2023). 10 U.S. Patent Nos. 10,314,828; 10,335,397; 10,456,384; 7,045,620; 7,612,199… “Asserted HE Patents” refers to claim 8 of U.S. Patent No. 8,642,573 (the “’573 Patent”), claim 6 of …of U.S. Patent No. 9,421,195 (the “’195 Patent”), and claims 11-12 of U.S. Patent No. 10,335,397 (the “…claims from three asserted method of use patents (“the HE Patents”), and that Norwich’s Original ANDA should…Amended ANDA contain a Paragraph IV patent certification to any patent held to have been infringed under	External link to document

Litigation summary and analysis for: NORWICH PHARMACEUTICALS, INC. v. BECERRA (D.D.C. 2023)

Last updated: July 8, 2026

NORWICH PHARMACEUTICALS, INC. v. BECERRA (1:23-cv-01611) Litigation Summary and Patent-Strategy Analysis

Executive summary: No accurate litigation summary can be produced from the docket identifier alone (“1:23-cv-01611”) and the party pair name (“NORWICH PHARMACEUTICALS, INC. v. BECERRA”). A docket-level recitation requires the case caption details and disposition records (court, filing date, asserted statutory basis, FDA/regulatory action challenged, challenged approvals, and any Orange Book or patent listing predicates). Without those case-specific facts, any purported “summary and analysis” would be incomplete.

What is the litigation claim in NORWICH PHARMACEUTICALS v. BECERRA 1:23-cv-01611?

Answer: Not determinable from the provided identifier and party names.

What FDA action is being challenged (approval, refusal, listing, or exclusivity determination)?

Answer: Not determinable.

What statute and procedural posture are implicated (Hatch-Waxman, APA, mandamus, or exclusivity framework)?

Answer: Not determinable.

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When was NORWICH PHARMACEUTICALS v. BECERRA (1:23-cv-01611) filed and how has it progressed?

Answer: Not determinable.

What are the key docket milestones (complaint, motion to dismiss, preliminary injunction, summary judgment)?

Answer: Not determinable.

Has the court issued an order or final disposition?

Answer: Not determinable.

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Which patents, Orange Book listings, or exclusivity determinations drive NORWICH PHARMACEUTICALS v. BECERRA?

Answer: Not determinable.

Are the disputes about method-of-use, formulation, polymorph, manufacturing, or labeling patents?

Answer: Not determinable.

Is the case tied to a Paragraph IV certification and a 21 U.S.C. § 355(j) dispute?

Answer: Not determinable.

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What is the legal theory and standard of review in Norwich v. Becerra?

Answer: Not determinable.

Is the challenge aimed at FDA’s statutory duties under FD&C or Hatch-Waxman?

Answer: Not determinable.

Does the case argue failure to act, arbitrary-and-capricious agency action, or ultra vires conduct?

Answer: Not determinable.

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How strong is Norwich’s position under administrative law based on the case record?

Answer: Not determinable.

What arguments do plaintiffs typically raise in Becerra-style FDA challenges?

Answer: Not determinable for this docket.

What defenses typically appear in these actions and how would they map to the Norwich filings?

Answer: Not determinable for this docket.

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What remedies are being sought in 1:23-cv-01611 (injunction, declaratory relief, remand)?

Answer: Not determinable.

Does Norwich seek a stay of FDA action, approval, or a correction of Orange Book listings?

Answer: Not determinable.

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Which companies are likely aligned on either side (ANDA applicant, brand sponsor, intervenors)?

Answer: Not determinable.

Is there any indication of related ANDA litigation or settlement tie-ins?

Answer: Not determinable.

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Commercial impact: could Norwich’s case affect generic entry timing or exclusivity for specific drug(s)?

Answer: Not determinable.

Which product or therapeutic area is implicated?

Answer: Not determinable.

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Key Takeaways

• A litigation summary and analysis cannot be produced from “NORWICH PHARMACEUTICALS, INC. v. BECERRA|1:23-cv-01611” alone without docket-specific facts (court, dates, claims, challenged FDA action, and disposition).
• No reliable mapping can be made to patents, Orange Book listings, Paragraph IV events, or exclusivity impacts without the case record.

FAQs

1. What does “1:23-cv-01611” mean for identifying the correct Norwich v. Becerra docket?
   Not determinable from provided text.

2. Is Norwich v. Becerra a Hatch-Waxman Paragraph IV dispute or an administrative-law challenge?
   Not determinable from provided text.

3. Does this case involve Orange Book patent listings, FDA exclusivity, or an NDA/ANDA approval decision?
   Not determinable from provided text.

4. Can Norwich’s case affect FDA approval timelines for an ANDA or biosimilar applicant?
   Not determinable from provided text.

5. Has the court ruled on motions (dismissal, injunction, summary judgment) in 1:23-cv-01611?
   Not determinable from provided text.

References

(No sources were cited because no docket-specific facts were provided.)