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BLA

TEPLIZUMAB-MZWV | B761183 | PROVENTION BIO INC

1 product0 Purple Book patents

Biologic LOEProtected

Estimated date when biosimilar competition may begin

November 17, 2034(3059 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Nov. 17, 2034	Active	Computed

Purple Book Patents

No listed patents in Purple Book.

Estimated Patent LOE

May. 2, 20446513 days remaining

Based on latest discovered patent 11976136(composition) · relevance 72/100

Estimate based on AI-discovered patents. No patents are officially listed in the Purple Book for this product.

Discovered Patents

View all 4 patents →

4 AI-discovered patents, sorted by relevance.

Composition

(1)

72/10011976136Grant: 2024-05-07 | Exp: 2044-05-02

Formulation

(1)

65/1008871201Grant: 2014-10-28 | Exp: 2034-10-23

Manufacturing

(2)

71/10010294307Grant: 2019-05-21 | Exp: 2039-05-16

68/10010047167Grant: 2018-08-14 | Exp: 2038-08-09

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Purple Book (Biologics)

BLA 761183

351(a) ReferenceLicensedCDERInjection

Proper Name

teplizumab-mzwv

Applicant

Provention Bio, Inc.

Approval Date

17-Nov-22

Source: FDA Purple Book (purplebooksearch.fda.gov).

Approval Letters

4 letters from Drugs@FDA

Date	Submission	Document
Jun 15, 2026	SUPPL -10	View Letter (PDF)
Jun 15, 2026	SUPPL -14	View Letter (PDF)
Apr 21, 2026	SUPPL -13	View Letter (PDF)
Nov 22, 2022	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 2MG/2ML(1MG/ML)

▴

INJECTABLE;INJECTION | Approved: 2022-11-17 00:00:00

No patent or exclusivity listings for this strength.