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Pharmaceutical Compositions Of Therapeutic Proteins

Abstract: The present invention relates to pharmaceutical compositions of therapeutic proteins which are selected from the group comprising of naturally occurring or recombinant parathyroid hormone(PTH) and its analogues such as teriparatide PTH (1-34), PTH (1-37), PTH (1-38), PTH (1-41), PTH (1-84) and the like; or their pharmaceutically acceptable salts, enantiomers, polymorphs, crystalline forms or mixtures thereof; atleast one suitable buffer or buffer system maintaining a pH range from about 2 to about 8 having a concentration from about 0.001 mM to about 1M; atleast one stabilizer with or without atleast one preservative or combinations thereof in any ratio, optionally with pharmaceutically acceptable excipients.

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Notices, Deadlines & Correspondence

Patent Information

Application #
Filing Date
21 December 2006
Publication Number
25/2009
Publication Type
INA
Invention Field
BIOTECHNOLOGY
Status
Email
Parent Application

Applicants

INTAS BIOPHARMACEUTICALS LIMITED
Gautam Bakshi IN/PA-1069 Intellectual Property Rights (IPR) Intas Biopharmaceuticals Limited Plot No: 423/P/A/GIDC Sarkhej-Bavla Highway Moraiya, Tal.: sanand Ahmedabad - 382 210

Inventors

1. TEJAS PRAKASH GUNJIKAR
Flat no 14, Gurukripa Society, Tagore Nagar, Nashik - 422006,
2. GAUTAM BAKSHI
House No: 290, Sector 4, Panchkula, Haryana - 134 112,
3. RUSTOM SORAB MODY
22, Upvan Villa, Near Gala gymkhana, Bopal, Ahmedabad - 380058,

Specification

FORM 2
THE PATENTS ACT, 1970
(39 of 1970)
&
The Patents Rules, 2003
PROVISIONAL/COMPLETE SPECIFICATION (See section 10 and rule 13)
Title: PHARMACEUTICAL COMPOSITIONS OF THERAPEUTIC PROTEINS
Intas Biopharmaceuticals Limited
An Indian company having its registered office at:
Plot No: 423/P/A/GIDC
Sarkhej-Bavla Highway
Moraiya, Tal.: Sanand
Ahmedabad - 382 210
Gujarat, India
The following specification describes the invention.

-2-
PHARMACEUTICAL COMPOSITIONS OF THERAPEUTIC PROTEINS
ABSTRACT
The present invention relates to pharmaceutical compositions of therapeutic proteins which are selected from the group comprising of naturally occurring or recombinant parathyroid hormone(PTH) and its analogues such as teriparatide PTH (1-34), PTH (1-37), PTH (1-38), PTH (1-41), PTH (1-84) and the like; or their pharmaceutically acceptable salts, enantiomers, polymorphs, crystalline forms or mixtures thereof; atleast one suitable buffer or buffer system maintaining a pH range from about 2 to about 8 having a concentration from about 0.001 mM to about 1M; atleast one stabilizer with or without atleast one preservative or combinations thereof in any ratio, optionally with pharmaceutically acceptable excipients. The pharmaceutical compositions of the present invention can either be in a powder form and/or as a liquid dosage form. The processes for preparing the pharmaceutical compositions as discussed in context of the present invention and method(s) of use and treatment are also described.

Dated: 20tn day of December 2006

Signed @¥^ Gautam Bakshi
(IN/ PA- 1069) Manager
Intellectual Property Rights (IPR) Intas Biopharmaceuticals Limited Plot No: 423/P/A/GIDC Sarkhej-Bavla Highway Moraiya, Tal.: Sanand Ahmedabad-382 210 Gujarat, India.

Documents

Orders

Section Controller Decision Date

Application Documents

# Name Date
1 2097-mum-2006-abstract(17-6-2008).pdf 2018-08-09
1 2097-mum-2006-form 2(title page)-(provisional)-(21-12-2006).pdf 2006-12-21
2 2097-mum-2006-form 2(title page)-(complete)-(21-12-2006).pdf 2006-12-21
2 2097-mum-2006-abstract(21-6-2007).pdf 2018-08-09
3 2097-mum-2006-form 2(provisional)-(21-12-2006).pdf 2006-12-21
3 2097-mum-2006-abstract.doc 2018-08-09
4 2097-mum-2006-form 2(complete)-(21-12-2006).pdf 2006-12-21
4 2097-mum-2006-abstract.pdf 2018-08-09
5 2097-mum-2006-form 1(21-12-2006).pdf 2006-12-21
5 2097-MUM-2006-CLAIMS(17-6-2008).pdf 2018-08-09
6 2097-mum-2006-drawing(21-12-2006).pdf 2006-12-21
6 2097-mum-2006-correspondance-received.pdf 2018-08-09
7 2097-mum-2006-description(provisional)-(21-12-2006).pdf 2006-12-21
7 2097-mum-2006-correspondence(17-6-2008).pdf 2018-08-09
8 2097-mum-2006-description(complete)-(21-12-2006).pdf 2006-12-21
8 2097-MUM-2006-CORRESPONDENCE(20-5-2013).pdf 2018-08-09
9 2097-MUM-2006-CORRESPONDENCE(6-6-2011).pdf 2018-08-09
9 2097-mum-2006-claims(21-12-2006).pdf 2006-12-21
10 2097-mum-2006-abstract(21-12-2006).pdf 2006-12-21
10 2097-mum-2006-correspondence(ipo)-(7-4-2008).pdf 2018-08-09
11 2097-MUM-2006-CORRESPONDENCE(IPO)-(DECISION)-(16-8-2016).pdf 2018-08-09
11 2097-MUM-2006-REPLY TO EXAMINATION REPORT-30-01-2015.pdf 2015-01-30
12 2097-MUM-2006-CORRESPONDENCE(IPO)-(FER)-(8-2-2014).pdf 2018-08-09
12 2097-MUM-2006-MARKED COPY-30-01-2015.pdf 2015-01-30
13 2097-MUM-2006-CORRESPONDENCE(IPO)-(HEARING NOTICE)-(21-4-2016).pdf 2018-08-09
13 2097-MUM-2006-FORM 3-30-01-2015.pdf 2015-01-30
14 2097-mum-2006-description (provisional).pdf 2018-08-09
14 2097-MUM-2006-FORM 26-30-01-2015.pdf 2015-01-30
15 2097-MUM-2006-CLAIMS-30-01-2015.pdf 2015-01-30
15 2097-MUM-2006-DESCRIPTION(COMPLETE)-(17-6-2008).pdf 2018-08-09
16 2097-mum-2006-form 1(17-6-2008).pdf 2018-08-09
16 2097-MUM-2006_EXAMREPORT.pdf 2018-08-09
17 2097-MUM-2006-FORM 18(6-6-2011).pdf 2018-08-09
17 2097-mum-2006-form-3.pdf 2018-08-09
18 2097-MUM-2006-FORM 2(COMPLETE)-(17-6-2008).pdf 2018-08-09
18 2097-mum-2006-form-2.pdf 2018-08-09
19 2097-MUM-2006-FORM 2(TITLE PAGE)-(COMPLETE)-(17-6-2008).pdf 2018-08-09
20 2097-mum-2006-form 2(title page)-(provisional)-(21-6-2007).pdf 2018-08-09
20 2097-mum-2006-form-1.pdf 2018-08-09
21 2097-MUM-2006-FORM 26(20-5-2013).pdf 2018-08-09
21 2097-mum-2006-form 5(17-6-2008).pdf 2018-08-09
22 2097-mum-2006-form 3(17-6-2008).pdf 2018-08-09
23 2097-MUM-2006-FORM 26(20-5-2013).pdf 2018-08-09
23 2097-mum-2006-form 5(17-6-2008).pdf 2018-08-09
24 2097-mum-2006-form 2(title page)-(provisional)-(21-6-2007).pdf 2018-08-09
24 2097-mum-2006-form-1.pdf 2018-08-09
25 2097-MUM-2006-FORM 2(TITLE PAGE)-(COMPLETE)-(17-6-2008).pdf 2018-08-09
26 2097-mum-2006-form-2.pdf 2018-08-09
26 2097-MUM-2006-FORM 2(COMPLETE)-(17-6-2008).pdf 2018-08-09
27 2097-mum-2006-form-3.pdf 2018-08-09
27 2097-MUM-2006-FORM 18(6-6-2011).pdf 2018-08-09
28 2097-mum-2006-form 1(17-6-2008).pdf 2018-08-09
28 2097-MUM-2006_EXAMREPORT.pdf 2018-08-09
29 2097-MUM-2006-CLAIMS-30-01-2015.pdf 2015-01-30
29 2097-MUM-2006-DESCRIPTION(COMPLETE)-(17-6-2008).pdf 2018-08-09
30 2097-mum-2006-description (provisional).pdf 2018-08-09
30 2097-MUM-2006-FORM 26-30-01-2015.pdf 2015-01-30
31 2097-MUM-2006-CORRESPONDENCE(IPO)-(HEARING NOTICE)-(21-4-2016).pdf 2018-08-09
31 2097-MUM-2006-FORM 3-30-01-2015.pdf 2015-01-30
32 2097-MUM-2006-CORRESPONDENCE(IPO)-(FER)-(8-2-2014).pdf 2018-08-09
32 2097-MUM-2006-MARKED COPY-30-01-2015.pdf 2015-01-30
33 2097-MUM-2006-CORRESPONDENCE(IPO)-(DECISION)-(16-8-2016).pdf 2018-08-09
33 2097-MUM-2006-REPLY TO EXAMINATION REPORT-30-01-2015.pdf 2015-01-30
34 2097-mum-2006-abstract(21-12-2006).pdf 2006-12-21
34 2097-mum-2006-correspondence(ipo)-(7-4-2008).pdf 2018-08-09
35 2097-mum-2006-claims(21-12-2006).pdf 2006-12-21
35 2097-MUM-2006-CORRESPONDENCE(6-6-2011).pdf 2018-08-09
36 2097-MUM-2006-CORRESPONDENCE(20-5-2013).pdf 2018-08-09
36 2097-mum-2006-description(complete)-(21-12-2006).pdf 2006-12-21
37 2097-mum-2006-correspondence(17-6-2008).pdf 2018-08-09
37 2097-mum-2006-description(provisional)-(21-12-2006).pdf 2006-12-21
38 2097-mum-2006-drawing(21-12-2006).pdf 2006-12-21
38 2097-mum-2006-correspondance-received.pdf 2018-08-09
39 2097-mum-2006-form 1(21-12-2006).pdf 2006-12-21
39 2097-MUM-2006-CLAIMS(17-6-2008).pdf 2018-08-09
40 2097-mum-2006-form 2(complete)-(21-12-2006).pdf 2006-12-21
40 2097-mum-2006-abstract.pdf 2018-08-09
41 2097-mum-2006-form 2(provisional)-(21-12-2006).pdf 2006-12-21
42 2097-mum-2006-form 2(title page)-(complete)-(21-12-2006).pdf 2006-12-21
42 2097-mum-2006-abstract(21-6-2007).pdf 2018-08-09
43 2097-mum-2006-form 2(title page)-(provisional)-(21-12-2006).pdf 2006-12-21
43 2097-mum-2006-abstract(17-6-2008).pdf 2018-08-09