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NATPARA

BLA

PARATHYROID HORMONE | B125511 | NPS PHARMS INC

4 products0 Purple Book patents

Biologic LOELOE within 1 year

Estimated date when biosimilar competition may begin

January 23, 2027(204 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Jan. 23, 2027	Active	Computed
7-Year Orphan	Jan. 23, 2022	Expired	Purple Book

Purple Book Patents

No listed patents in Purple Book.

Estimated Patent LOE

May. 8, 20456884 days remaining

Based on latest discovered patent 12295989(composition) · relevance 88/100

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

Discovered Patents

View all 60 patents →

Top 50 of 60 AI-discovered patents by relevance.

Composition

(34)

93/1006537965Grant: 2003-03-25 | Exp: 2023-03-20

92/100OB11759504Grant: 2023-09-19 | Exp: 2043-09-14

92/1007022815Grant: 2006-04-04 | Exp: 2026-03-30

92/1008563513Grant: 2013-10-22 | Exp: 2033-10-17

92/1006803213Grant: 2004-10-12 | Exp: 2024-10-07

92/10012291556Grant: 2025-05-06 | Exp: 2045-05-01

90/100OB11918628Grant: 2024-03-05 | Exp: 2044-02-29

90/1006417333Grant: 2002-07-09 | Exp: 2022-07-04

90/1007371844Grant: 2008-05-13 | Exp: 2028-05-08

89/1007521528Grant: 2009-04-21 | Exp: 2029-04-16

89/1007572765Grant: 2009-08-11 | Exp: 2029-08-06

88/100OB12295989Grant: 2025-05-13 | Exp: 2045-05-08

88/10011780901Grant: 2023-10-10 | Exp: 2043-10-05

88/10011975050Grant: 2024-05-07 | Exp: 2044-05-02

88/1008143374Grant: 2012-03-27 | Exp: 2032-03-22

88/1007910544Grant: 2011-03-22 | Exp: 2031-03-17

88/10010501518Grant: 2019-12-10 | Exp: 2039-12-05

88/10011634468Grant: 2023-04-25 | Exp: 2043-04-20

88/10010960054Grant: 2021-03-30 | Exp: 2041-03-25

88/1007985835Grant: 2011-07-26 | Exp: 2031-07-21

88/1007153951Grant: 2006-12-26 | Exp: 2026-12-21

88/1009492508Grant: 2016-11-15 | Exp: 2036-11-10

85/1007057012Grant: 2006-06-06 | Exp: 2026-06-01

85/1006362163Grant: 2002-03-26 | Exp: 2022-03-21

85/1007795220Grant: 2010-09-14 | Exp: 2030-09-09

85/1008568736Grant: 2013-10-29 | Exp: 2033-10-24

85/1007078487Grant: 2006-07-18 | Exp: 2026-07-13

85/1007244834Grant: 2007-07-17 | Exp: 2027-07-12

82/1008658854Grant: 2014-02-25 | Exp: 2034-02-20

82/10011878063Grant: 2024-01-23 | Exp: 2044-01-18

82/100OB11890326Grant: 2024-02-06 | Exp: 2044-02-01

80/1008603977Grant: 2013-12-10 | Exp: 2033-12-05

75/1006541220Grant: 2003-04-01 | Exp: 2023-03-27

75/1006495662Grant: 2002-12-17 | Exp: 2022-12-12

Formulation

(3)

92/100OB11590207Grant: 2023-02-28 | Exp: 2043-02-23

91/100OB11857603Grant: 2024-01-02 | Exp: 2043-12-28

78/1008802622Grant: 2014-08-12 | Exp: 2034-08-07

Method of Use

(9)

88/1007776334Grant: 2010-08-17 | Exp: 2030-08-12

88/10011318166Grant: 2022-05-03 | Exp: 2042-04-28

85/1008309095Grant: 2012-11-13 | Exp: 2032-11-08

85/1007270968Grant: 2007-09-18 | Exp: 2027-09-13

82/1007635477Grant: 2009-12-22 | Exp: 2029-12-17

82/1007429383Grant: 2008-09-30 | Exp: 2028-09-25

82/1008008074Grant: 2011-08-30 | Exp: 2031-08-25

75/1008802104Grant: 2014-08-12 | Exp: 2034-08-07

72/1007943136Grant: 2011-05-17 | Exp: 2031-05-12

Manufacturing

(3)

78/10010870830Grant: 2020-12-22 | Exp: 2040-12-17

75/1006309859Grant: 2001-10-30 | Exp: 2021-10-25

75/1006287806Grant: 2001-09-11 | Exp: 2021-09-06

Diagnostic

(1)

72/1007033773Grant: 2006-04-25 | Exp: 2026-04-20

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 125511 | 4 presentations

351(a) ReferenceLicensedCDERFor Injection

Proper Name

parathyroid hormone

Applicant

Takeda Pharmaceuticals U.S.A., Inc.

Approval Date

23-Jan-15

Orphan Exclusivity

23-Jan-22

Expired

Presentations

25MCG — Multi-Dose Vial (Subcutaneous)

50MCG — Multi-Dose Vial (Subcutaneous)

75MCG — Multi-Dose Vial (Subcutaneous)

100MCG — Multi-Dose Vial (Subcutaneous)

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

Approval Letters

8 letters from Drugs@FDA

Date	Submission	Document
Apr 8, 2022	SUPPL -28	View Letter (PDF)
Jul 14, 2020	SUPPL -20	View Letter (PDF)
Jun 9, 2020	SUPPL -21	View Letter (PDF)
Dec 21, 2018	SUPPL -16	View Letter (PDF)
Oct 1, 2018	SUPPL -14	View Letter (PDF)
Oct 3, 2016	SUPPL -2	View Letter (PDF)
Jun 21, 2016	SUPPL -4	View Letter (PDF)
Jan 26, 2015	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 25MCG

▴

INJECTABLE;INJECTION | Approved: 2015-01-23 00:00:00

No patent or exclusivity listings for this strength.

#002 — 50MCG

▾

INJECTABLE;INJECTION | Approved: 2015-01-23 00:00:00

#003 — 75MCG

▾

INJECTABLE;INJECTION | Approved: 2015-01-23 00:00:00

#004 — 100MCG

▾

INJECTABLE;INJECTION | Approved: 2015-01-23 00:00:00