Viewing data from:

REGRANEX

BLA

BECAPLERMIN | B103691 | SMITH AND NEPHEW

1 product0 Purple Book patents

Biologic LOENo LOE data

No exclusivity dates or listed patents found in Purple Book

Purple Book Patents

No listed patents in Purple Book.

Estimated Patent LOE

Jun. 26, 20456933 days remaining

Based on latest discovered patent 12344666(composition) · relevance 75/100

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

Discovered Patents

View all 29 patents →

29 AI-discovered patents, sorted by relevance.

Composition

(6)

86/1007081240Grant: 2006-07-25 | Exp: 2026-07-20

85/1006903078Grant: 2005-06-07 | Exp: 2025-06-02

82/10011542490Grant: 2023-01-03 | Exp: 2042-12-29

75/10012344666Grant: 2025-07-01 | Exp: 2045-06-26

72/1007186407Grant: 2007-03-06 | Exp: 2027-03-01

72/1009034646Grant: 2015-05-19 | Exp: 2035-05-14

Formulation

(6)

94/10010071182Grant: 2018-09-11 | Exp: 2038-09-06

90/10011826486Grant: 2023-11-28 | Exp: 2043-11-23

88/10012109324Grant: 2024-10-08 | Exp: 2044-10-03

65/1006306432Grant: 2001-10-23 | Exp: 2021-10-18

65/10012303483Grant: 2025-05-20 | Exp: 2045-05-15

55/1007635473Grant: 2009-12-22 | Exp: 2029-12-17

Method of Use

(1)

55/1008012947Grant: 2011-09-06 | Exp: 2031-09-01

Manufacturing

(7)

88/1006448382Grant: 2002-09-10 | Exp: 2022-09-05

88/1006897043Grant: 2005-05-24 | Exp: 2025-05-19

85/1006706496Grant: 2004-03-16 | Exp: 2024-03-11

85/1006312923Grant: 2001-11-06 | Exp: 2021-11-01

79/1007084262Grant: 2006-08-01 | Exp: 2026-07-27

72/1007166446Grant: 2007-01-23 | Exp: 2027-01-18

60/1006642029Grant: 2003-11-04 | Exp: 2023-10-30

Device

(9)

72/10011793924Grant: 2023-10-24 | Exp: 2043-10-19

65/1008128615Grant: 2012-03-06 | Exp: 2032-03-01

55/1008926592Grant: 2015-01-06 | Exp: 2035-01-01

55/10011045358Grant: 2021-06-29 | Exp: 2041-06-24

55/10010912869Grant: 2021-02-09 | Exp: 2041-02-04

50/1009227000Grant: 2016-01-05 | Exp: 2035-12-31

50/10011426497Grant: 2022-08-30 | Exp: 2042-08-25

50/10010758651Grant: 2020-09-01 | Exp: 2040-08-27

50/10010258779Grant: 2019-04-16 | Exp: 2039-04-11

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 103691

351(a) ReferenceLicensedCDERGel

Proper Name

becaplermin

Applicant

Smith & Nephew, Inc.

Approval Date

16-Dec-97

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

Approval Letters

6 letters from Drugs@FDA

Date	Submission	Document
Aug 27, 2019	SUPPL -5138	View Letter (PDF)
Dec 19, 2018	SUPPL -5134	View Letter (PDF)
May 3, 2012	SUPPL -5109	View Letter (PDF)
Oct 23, 2008	SUPPL -5074	View Letter (PDF)
May 20, 2005	SUPPL -5015	View Letter (PDF)
Mar 11, 2004	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 100UG/G

▴

GEL; TOPICAL | Approved: 1997-12-16 00:00:00

No patent or exclusivity listings for this strength.